Infekcja wirusem cytomegalii
Diagnostyka i diagnoza

Infekcja wirusem cytomegalii (CMV) jest istotnym problemem klinicznym, szczególnie u noworodków z zakażeniem wrodzonym oraz u pacjentów z upośledzoną odpornością. Diagnostyka CMV opiera się na metodach serologicznych (ocena przeciwciał IgG, IgM oraz awidności IgG), molekularnych (PCR jakościowy, ilościowy i cyfrowy dPCR), testach antygenemii pp65 oraz klasycznych metodach hodowlanych i badaniach histopatologicznych. W diagnostyce prenatalnej złotym standardem jest PCR płynu owodniowego, wykonywany po 21. tygodniu ciąży, z czułością 78-98% i swoistością 92-98%. U noworodków do potwierdzenia zakażenia wrodzonego stosuje się PCR śliny i moczu pobranych w ciągu pierwszych 3 tygodni życia. Monitorowanie wiremii CMV za pomocą ilościowego PCR jest kluczowe w ocenie przebiegu zakażenia i odpowiedzi na leczenie, zwłaszcza u pacjentów po przeszczepach oraz u noworodków z objawowym zakażeniem.

Diagnostyka infekcji wirusem cytomegalii

Infekcja wirusem cytomegalii (CMV) stanowi jedną z najczęstszych infekcji wirusowych na świecie, mającą szczególne znaczenie kliniczne w przypadku zakażeń wrodzonych oraz u pacjentów z upośledzoną odpornością. Prawidłowa i szybka diagnostyka zakażenia CMV jest kluczowa dla wdrożenia odpowiedniego postępowania terapeutycznego12. Diagnostyka CMV obejmuje szereg metod laboratoryjnych, umożliwiających wykrycie wirusa, jego antygenów lub kwasów nukleinowych w różnych płynach ustrojowych lub próbkach tkanek3.

Diagnostyka serologiczna

Testy serologiczne stanowią powszechnie stosowaną metodę diagnostyczną, pozwalającą ocenić obecność przeciwciał anty-CMV w surowicy pacjenta45:

  • Wykrywanie przeciwciał klasy IgG – wskazuje na przebytą w przeszłości lub obecną infekcję CMV, jednak nie określa dokładnie czasu zakażenia4
  • Wykrywanie przeciwciał klasy IgM – może sugerować aktywną lub niedawną infekcję, jednak wykrycie samych przeciwciał IgM nie jest wystarczające do zdiagnozowania pierwotnej infekcji CMV, gdyż mogą one utrzymywać się przez miesiące po pierwotnym zakażeniu oraz pojawiać się w przypadku reaktywacji zakażenia56
  • Testy awidności IgG – mierzą siłę wiązania przeciwciał IgG z wirusem, co pomaga w różnicowaniu między pierwotną a przeszłą infekcją CMV78

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Do wykrywania przeciwciał anty-CMV najczęściej stosuje się test immunoenzymatyczny ELISA (ang. enzyme-linked immunosorbent assay)4. Pomiar poziomu przeciwciał IgG w parowanych próbkach pobranych w odstępie 1-3 miesięcy może służyć do diagnostyki pierwotnej infekcji7. Serokonwersja (zmiana wyników z negatywnych na pozytywne) lub czterokrotny wzrost miana przeciwciał IgG świadczy o świeżym zakażeniu8.

Diagnostyka molekularna

Reakcja łańcuchowa polimerazy (PCR) jest obecnie powszechnie stosowaną metodą wykrywania CMV, bazującą na amplifikacji kwasów nukleinowych10:

  • PCR jakościowy – służy do wykrywania obecności DNA wirusa
  • PCR ilościowy (real-time PCR) – umożliwia nie tylko wykrycie, ale także ilościowe określenie liczby kopii wirusa (wiremii), co pozwala na monitorowanie przebiegu zakażenia i odpowiedzi na leczenie106
  • Cyfrowy PCR (dPCR) – bardziej precyzyjna, powtarzalna i możliwa do ilościowego określenia metoda niż real-time PCR, szczególnie w próbkach o niskim mianie wirusa11

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Metody molekularne charakteryzują się wysoką czułością i swoistością, a ich wyniki są dostępne szybciej niż w przypadku klasycznych metod hodowlanych13. Stanowią one metodę z wyboru w diagnostyce i monitorowaniu zakażeń CMV u pacjentów z upośledzoną odpornością oraz w diagnostyce zakażeń wrodzonych1411.

Test antygenemii

Test antygenemii pp65 jest metodą wykrywającą antygen białka pp65 wirusa CMV w leukocytach krwi obwodowej15. Jest stosowany od ponad dekady do oceny ilościowej wirusa CMV we krwi i wykazuje dobrą korelację z wiremią oraz nasileniem klinicznym choroby u pacjentów z upośledzeniem odporności5. Obecność antygenemii świadczy o aktywnej replikacji wirusa15.

Badanie antygenemii jest czułe i swoiste, a wyniki dostępne są w krótkim czasie. Niski lub umiarkowany poziom antygenemii CMV u pacjentów z upośledzeniem odporności może wskazywać na reaktywację lub nowe zakażenie15. Wykazano, że test antygenemii pp65 i ilościowy PCR CMV mają podobną skuteczność w diagnostyce i monitorowaniu pacjentów z aktywnym zakażeniem CMV15.

Klasyczne metody hodowlane

Tradycyjną metodą wykrywania CMV jest hodowla komórkowa5:

  • Klasyczna hodowla wirusowa – metoda ta wymaga 2-3 tygodni do uzyskania wyników5
  • Szybka hodowla metodą shell vial – umożliwia uzyskanie wyników w ciągu 24-36 godzin16

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Hodowla wirusowa wykrywająca wirusa w moczu lub ślinie pobranej w ciągu pierwszych dwóch tygodni życia jest uznawana za złoty standard w diagnostyce wrodzonego zakażenia CMV1. Jednak metoda ta charakteryzuje się niską czułością i wymaga utrzymywania hodowli przez ponad 28 dni, zanim zostanie uznana za negatywną11.

Badania histopatologiczne

Histopatologiczne badanie bioptatów tkanek, ukazujące charakterystyczne wtrętowe ciałka wewnątrzjądrowe (ang. owl’s eye inclusions), jest ważnym elementem diagnostycznym, szczególnie w przypadku narządowej postaci zakażenia CMV1712. Obecność tych zmian jest wysoce sugestywna dla zakażenia CMV18.

Diagnoza może być potwierdzona za pomocą hybrydyzacji in situ lub bezpośredniego albo pośredniego barwienia wtrętów wewnątrzjądrowych przy użyciu przeciwciał specyficznych dla CMV12. Metody immunohistochemiczne są wysoce swoistym sposobem potwierdzenia obecności wirusa19.

Diagnostyka wrodzonego zakażenia CMV

Wrodzone zakażenie CMV jest najczęstszą wirusową infekcją wrodzoną u ludzi i główną przyczyną niedosłuchu czuciowo-nerwowego pochodzenia niegenetycznego u dzieci120. Wczesna i prawidłowa diagnostyka ma kluczowe znaczenie dla podjęcia odpowiedniego leczenia i monitorowania pacjenta21.

Diagnostyka prenatalna

W przypadku podejrzenia zakażenia CMV w ciąży, wykonuje się następujące badania:

  • Badania serologiczne u ciężarnej – obecność swoistych przeciwciał IgM, przy jednoczesnej obecności przeciwciał IgG o niskiej awidności, sugeruje pierwotne zakażenie CMV w czasie ciąży2223
  • Amniocenteza – złoty standard w diagnostyce prenatalnej zakażenia płodu, polegający na pobraniu płynu owodniowego i wykryciu DNA wirusa metodą PCR1024

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Najwyższą czułość badania płynu owodniowego uzyskuje się, wykonując amniocentezę po 21. tygodniu ciąży i co najmniej 6 tygodni po pierwszym dodatnim wyniku badania serologicznego u matki1025. Czułość PCR płynu owodniowego wynosi 78-98% (swoistość 92-98%), podczas gdy czułość hodowli wirusowej płynu owodniowego wynosi 70-80%24.

Należy pamiętać, że wykrycie CMV w płynie owodniowym potwierdza zakażenie wrodzone, ale nie przewiduje ciężkości zakażenia24.

Diagnostyka postnatalna

Diagnostyka wrodzonego zakażenia CMV u noworodków polega na bezpośrednim wykrywaniu wirusa, jego antygenów lub materiału genetycznego w próbkach biologicznych pobranych w ciągu pierwszych 2-3 tygodni życia2616:

  • Badanie śliny – metoda PCR śliny jest preferowaną metodą diagnostyczną do badań przesiewowych w kierunku wrodzonego zakażenia CMV ze względu na łatwość pobrania materiału i wysoką czułość427
  • Badanie moczu – klasycznie uznawane za złoty standard w diagnostyce wrodzonego zakażenia CMV1627
  • Badanie krwi – ma mniejsze znaczenie w diagnostyce wrodzonego zakażenia CMV niż badanie śliny czy moczu26

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Materiał do badań musi być pobrany w ciągu pierwszych 3 tygodni życia, aby móc potwierdzić zakażenie wrodzone. Po tym czasie nie można jednoznacznie rozstrzygnąć, czy zakażenie ma charakter wrodzony, czy też zostało nabyte po urodzeniu2829.

Noworodki z potwierdzonym wrodzonym zakażeniem CMV wymagają dalszych badań, takich jak badanie słuchu, badanie okulistyczne oraz obrazowanie mózgu, w celu oceny zasięgu i ciężkości zakażenia3031.

Markery ciężkości zakażenia

Rola wiremii (ilościowej obecności wirusa) jako markera ciężkości choroby i czynnika prognostycznego dla wyników długoterminowych jest przedmiotem badań. Dotychczasowe dane wskazują na wyższy poziom wyjściowej wiremii u dzieci z umiarkowanymi do ciężkich objawami w porównaniu z pacjentami asymptomatycznymi32.

Wartość prognostyczna ilościowego oznaczania CMV w próbkach od noworodków, szczególnie z asymptomatycznym zakażeniem, jest niejasna. Rola obciążenia wirusem we krwi obwodowej, moczu i ślinie w przebiegu choroby i jej wyniku wymaga dalszych badań33.

Diagnostyka zakażenia CMV u pacjentów z upośledzeniem odporności

Zakażenie CMV u pacjentów z upośledzeniem odporności może prowadzić do ciężkiej choroby narządowej, dlatego szybka i dokładna diagnostyka jest kluczowa dla wprowadzenia odpowiedniego leczenia18.

Metody diagnostyczne u pacjentów po przeszczepach

U pacjentów po przeszczepach narządów lub komórek macierzystych stosuje się następujące metody diagnostyczne34:

  • Ilościowy PCR (qPCR) – wykonywany z osocza lub krwi pełnej jest podstawowym testem w wykrywaniu i monitorowaniu zakażenia CMV u pacjentów po przeszczepach6
  • Test antygenemii pp65 – alternatywna metoda do monitorowania aktywnego zakażenia CMV15
  • Badania w kierunku oporności na leki przeciwwirusowe – przy podejrzeniu oporności na leki zaleca się badania genetyczne w celu wykrycia mutacji w genach UL97 i UL54, odpowiedzialnych za oporność na gancyklowir i/lub foskarnet3536

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Ilościowy pomiar CMV w osoczu lub krwi pełnej pozwala na monitorowanie zakażenia i odpowiedzi na leczenie przeciwwirusowe38. Badania diagnostyczne są niezbędne dla wczesnego wykrywania reaktywacji lub nowych zakażeń, co umożliwia wdrożenie terapii wyprzedzającej37.

Diagnostyka choroby narządowej

Zapalenie siatkówki wywołane przez CMV jest najczęściej diagnozowane na podstawie charakterystycznych zmian siatkówkowych obserwowanych podczas badania okulistycznego18. Wykrycie DNA CMV w płynie mózgowo-rdzeniowym, cieczy szklistej lub wodnej oka jest wysoce sugestywne dla CMV jako przyczyny choroby ocznej39.

Choroba CMV przewodu pokarmowego jest definiowana jako połączenie objawów z górnego i dolnego odcinka przewodu pokarmowego, zmian śluzówkowych widocznych w endoskopii oraz wykrycia CMV za pomocą hodowli, badania histopatologicznego, immunohistochemii lub hybrydyzacji in situ40.

Zapalenie płuc wywołane przez CMV jest diagnozowane na podstawie zgodnych objawów klinicznych i radiologicznych (rozlane śródmiąższowe nacieki płucne, gorączka, kaszel lub duszność), identyfikacji licznych ciałek wtrętowych CMV w tkance płucnej lub badaniu cytologicznym oraz braku innych patogenów częściej związanych z zapaleniem płuc4142.

Interpretacja wyników badań

Właściwa interpretacja wyników badań diagnostycznych w kierunku CMV wymaga uwzględnienia kontekstu klinicznego oraz ograniczeń poszczególnych metod diagnostycznych43.

Interpretacja testów serologicznych

  • Dodatni wynik IgG przy ujemnym IgM – wskazuje na przebyte w przeszłości zakażenie CMV i obecność odporności6
  • Dodatni wynik IgM i IgG – może wskazywać na świeże zakażenie CMV lub reaktywację przebytego zakażenia43
  • Dodatni wynik IgM przy ujemnym IgG – może sugerować wczesne stadium pierwotnego zakażenia CMV, jednak do potwierdzenia rozpoznania konieczne są dodatkowe badania6
  • Ujemny wynik IgG – wskazuje, że pacjent nie był wcześniej narażony na CMV i jest podatny na pierwotne zakażenie39

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Należy pamiętać, że obecność przeciwciał anty-CMV w surowicy nie zawsze świadczy o aktywnym zakażeniu, ponieważ duża część populacji ogólnej miała kontakt z CMV i jest seropozytywna45. Z drugiej strony, ujemny poziom przeciwciał IgG wskazuje, że CMV jest mało prawdopodobną przyczyną procesu chorobowego39.

Interpretacja testów molekularnych

Dodatni wynik PCR DNA CMV może wskazywać na obecność aktywnego zakażenia CMV43. W przypadku monitorowania skuteczności leczenia, zmniejszające się poziomy CMV (wiremii) oznaczają odpowiedź na leczenie przeciwwirusowe43.

W przypadku pacjentów z upośledzeniem odporności, negatywny wynik PCR CMV przemawia przeciwko reaktywacji, ale nie wyklucza zakażenia12. Należy pamiętać, że u pacjentów z upośledzeniem odporności wiremie mogą być niewykrywalne w niektórych przypadkach, dlatego ujemny wynik PCR nie wyklucza zakażenia CMV17.

Interpretacja badań u noworodków

Wykrycie DNA CMV w moczu, ślinie lub krwi noworodka w ciągu pierwszych 3 tygodni życia potwierdza wrodzone zakażenie CMV28. Po upływie 3 tygodni od urodzenia nie można jednoznacznie stwierdzić, czy zakażenie ma charakter wrodzony, czy też zostało nabyte po urodzeniu29.

W przypadku dodatniego wyniku badania PCR śliny, szczególnie u noworodków karmionych piersią, zaleca się potwierdzenie wyniku za pomocą badania moczu, aby wykluczyć potencjalne zanieczyszczenie próbki śliny wirusem CMV z mleka matki33.

Badania przesiewowe i problemy diagnostyczne

Pomimo znacznego obciążenia zdrowotnego, społecznego i ekonomicznego, wrodzone zakażenie CMV często pozostaje niewykryte w momencie urodzenia, ponieważ większość zakażonych noworodków jest bezobjawowa lub prezentuje objawy niespecyficzne, które nie skłaniają klinicystów do podejrzewania zakażenia CMV46.

Badania przesiewowe

Obecnie nie zaleca się rutynowego badania przesiewowego wszystkich kobiet ciężarnych w kierunku pierwotnego zakażenia CMV2247. Większość (około 90%) dodatnich wyników IgM jest fałszywie dodatnia i prawdopodobnie wynika z reakcji krzyżowych z innymi przeciwciałami nie-CMV. Ograniczenia badania przeciwciał IgM w różnicowaniu zakażenia pierwotnego od nawrotowego utrudniają również wykorzystanie wyników w poradnictwie pacjentów dotyczącym ryzyka dla płodu47.

W niektórych krajach rozważa się wprowadzenie powszechnych badań przesiewowych noworodków w kierunku wrodzonego zakażenia CMV, a w Kanadzie, w prowincji Ontario, takie badania już rozpoczęto48. Noworodki, które nie przechodzą badania przesiewowego słuchu, są w niektórych stanach poddawane ukierunkowanym badaniom w kierunku CMV4.

Opracowanie niedrogiej, czułej i szybkiej metody diagnostycznej do badań przesiewowych noworodków w kierunku wrodzonego CMV jest pilnie potrzebne3249.

Trudności diagnostyczne

Jednym z głównych wyzwań w diagnostyce CMV jest brak standaryzacji metod diagnostycznych, zwłaszcza w zakresie protokołów PCR czasu rzeczywistego, co utrudnia porównywanie wyników między różnymi ośrodkami i opracowanie jednolitych wytycznych dotyczących postępowania w przypadku inwazyjnych zakażeń CMV u osób z upośledzeniem odporności1.

W przypadku wykorzystania suchej kropli krwi (DBS) do retrospektywnej diagnostyki wrodzonego zakażenia CMV, głównym problemem jest niska czułość tej metody. Powody niskiej czułości PCR DBS w identyfikacji niemowląt z wrodzonym zakażeniem CMV nie są do końca jasne38.

Kalibracja i raportowanie wiremii CMV w międzynarodowych jednostkach na mililitr (IU/ml) poprawiły harmonizację wyników z różnych laboratoriów. Jednak zarządzanie aktywnym zakażeniem CMV nadal jest utrudnione przez ograniczoną porównywalność wyników między materiałami referencyjnymi a próbkami klinicznymi oraz brak opartych na dowodach progów wiremii50.

Implikacje terapeutyczne wyników diagnostycznych

Wyniki badań diagnostycznych w kierunku CMV mają bezpośrednie implikacje dla decyzji terapeutycznych51.

Leczenie wrodzonego zakażenia CMV

Leczenie przeciwwirusowe jest zalecane dla noworodków z objawowym wrodzonym zakażeniem CMV52. Najczęściej stosowanymi lekami są gancyklowir i walgancyklowir53.

Badania wykazały, że leczenie przeciwwirusowe może zmniejszyć utratę słuchu u 5 na 6 noworodków oraz poprawić długoterminowe wyniki rozwoju mózgu u niektórych pacjentów5455.

Obecnie zaleca się stosowanie doustnego walgancyklowiru przez 12 miesięcy w przypadku objawowego wrodzonego zakażenia CMV21. Nie zaleca się rutynowego stosowania leków przeciwwirusowych u noworodków z łagodnie objawową chorobą po urodzeniu, u noworodków poniżej 32 tygodnia ciąży lub u niemowląt starszych niż 30 dni ze względu na niewystarczające dowody z badań21.

Leczenie zakażenia CMV u pacjentów z upośledzeniem odporności

U pacjentów z upośledzeniem odporności, decyzje terapeutyczne opierają się na wynikach badań diagnostycznych, w tym na poziomie wiremii56.

Doustny walgancyklowir, dożylny gancyklowir lub indukcja dożylnym gancyklowirem, a następnie podtrzymanie doustnym walgancyklowirem są terapiami pierwszego rzutu w leczeniu zapalenia siatkówki wywołanego przez CMV56.

W przypadku zapalenia jelita grubego lub przełyku, wielu specjalistów zaleca terapię przeciw-CMV przez 21 do 42 dni lub do ustąpienia objawów. Dożylny gancyklowir jest zazwyczaj lekiem z wyboru i można go zamienić na doustny walgancyklowir, gdy pacjent może tolerować i wchłaniać leki doustne56.

W przypadku podejrzenia oporności na leki, zaleca się stosowanie alternatywnej terapii w oparciu o wyniki badań genetycznych. Mutacja UL54 jest związana z opornością na gancyklowir i krzyżową opornością na cidofowir. Mutacja UL97 jest również związana z opornością na gancyklowir36.

Monitorowanie odpowiedzi na leczenie

Badania diagnostyczne odgrywają kluczową rolę w monitorowaniu odpowiedzi na leczenie przeciwwirusowe u pacjentów zakażonych CMV57. Ilościowy PCR umożliwia ocenę wiremii przed, w trakcie i po zakończeniu leczenia38.

Zmniejszające się poziomy CMV (wiremii) wskazują na odpowiedź na leczenie przeciwwirusowe43. W przypadku braku odpowiedzi na leczenie, należy rozważyć możliwość oporności na leki i wykonać odpowiednie badania genetyczne58.

W przypadku objawowego wrodzonego zakażenia CMV, celem leczenia jest zmniejszenie wiremii o 1-2 log29. Jeśli nie obserwuje się odpowiedzi, należy skonsultować się z wirusologiem lub specjalistą chorób zakaźnych29.

Postępy w diagnostyce CMV

Ostatnie postępy w diagnostyce CMV mają na celu zwiększenie czułości, swoistości i dostępności testów59.

Nowe technologie diagnostyczne

Technologie wykorzystywane do identyfikacji CMV ewoluowały w ciągu ostatniego półwiecza. Testy oparte na metodach amplifikacji kwasów nukleinowych (np. PCR) stały się obecnym standardem rutynowego badania próbek w wielu matrycach tkankowych25.

Rozwój testów PCR na materiałach takich jak ślina może potencjalnie umożliwić adaptację tych metod w sposób wysokowydajny do badań przesiewowych dużej liczby noworodków w kierunku wrodzonego zakażenia CMV38.

Dzięki ulepszonym technikom i ciągłemu monitorowaniu wirusa przez diagnostykę, testy laboratoryjne CMV w kierunku zakażeń u noworodków są w prawie 90% dokładne50.

Badania w kierunku oporności na leki

Badania w kierunku oporności na leki przeciwwirusowe są obecnie powszechne w ośrodkach transplantacyjnych60. Oporność na gancyklowir obserwowano u wielu pacjentów po przeszczepach, co utrudnia leczenie60.

Do wykrywania oporności na leki przeciwwirusowe stosuje się obecnie metody genotypowe, które polegają na wykrywaniu mutacji w genach UL54, UL56 i/lub UL97, związanych z opornością na leki35.

Testowanie w kierunku oporności na leki jest zalecane w przypadku pacjentów z podejrzeniem opornego lub opornego na leczenie zakażenia CMV35.

Standaryzacja metod diagnostycznych

Standaryzacja metod diagnostycznych, zwłaszcza protokołów PCR, jest ważnym wyzwaniem w diagnostyce CMV1.

Kalibracja i raportowanie wiremii CMV w międzynarodowych jednostkach na mililitr (IU/ml) poprawiły harmonizację wyników z różnych laboratoriów. Jednak zarządzanie aktywnym zakażeniem CMV nadal jest utrudnione przez ograniczoną porównywalność wyników między materiałami referencyjnymi a próbkami klinicznymi oraz brak opartych na dowodach progów wiremii50.

Przy wykorzystaniu NAAT (testów amplifikacji kwasów nukleinowych) klinicyści powinni brać pod uwagę następujące czynniki: (1) rodzaj próbki (tj. mocz, ślina, krew pełna lub osocze), (2) granice wykrywalności i kwantyfikacji wybrane przez laboratorium kliniczne, (3) zakres liniowy testu oraz (4) powtarzalność w danej instytucji61.

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  1. 09.04.2026
  2. www.leksykon.com.pl

Materiały źródłowe

  • #1 Diagnosis of Cytomegalovirus Infections
    https://pmc.ncbi.nlm.nih.gov/articles/PMC3730495/
    Cytomegalovirus (CMV) is recognized as the most common congenital viral infection in humans and an important cause of morbidity and mortality in immunocompromised hosts. […] This recognition of the clinical importance of invasive CMV disease in the setting of immunodeficiency and in children with congenital CMV infection has led to the development of new diagnostic procedures for the rapid identification of immunocompromised individuals with CMV disease, as well as fetuses and infants with congenital infection. Diagnosis of acute maternal CMV infection by the presence of IgM and low IgG avidity requires confirmation of fetal infection which is typically performed by CMV PCR of the amniotic fluid. […] Viral culture of the urine and saliva obtained within the first two weeks of life continue to be the gold standard for diagnosis of congenitally infected infants. […] However, saliva PCR assays are currently being assessed as a useful screening method for congenital CMV infection. In the immunocompromised host, newer rapid diagnostic assays such as pp65 antigenemia and real-time CMV PCR of blood or plasma have allowed for preemptive treatment reducing morbidity and mortality. […] However, lack of standardized real-time PCR protocols hinders the comparison of the data across different centers and the development of uniform guidelines for the management of invasive CMV infections in immunocompromised individuals.
  • #2 Approach to the diagnosis of cytomegalovirus infection – UpToDate
    https://www.uptodate.com/contents/approach-to-the-diagnosis-of-cytomegalovirus-infection
    Approach to the diagnosis of cytomegalovirus infection […] The diagnosis and monitoring of CMV infection and tissue-invasive disease will be discussed here, with an emphasis on the role of diagnostic tests and their strengths and limitations. […] CMV infection refers to virus isolation or detection of viral proteins (antigens) or nucleic acid in any body fluid or tissue specimen regardless of symptoms or signs.
  • #3 Cytomegalovirus (CMV) infection – Diagnosis & treatment – Mayo Clinic
    https://www.mayoclinic.org/diseases-conditions/cmv/diagnosis-treatment/drc-20355364
    Laboratory tests including tests of blood and other body fluids or tests of tissue samples can detect cytomegalovirus (CMV). […] If your doctor detects a new CMV infection while you’re pregnant, a prenatal test (amniocentesis) can determine whether the fetus has been infected. […] Testing for CMV can also be important if you have a weakened immune system. […] If your doctor suspects your baby has congenital CMV, it’s important to test the baby within the first three weeks of birth. […] Your doctor will likely ask you a number of questions, including: How long have you had your symptoms? […] What tests do I need? […] Have you been tested for CMV before?
  • #4 Laboratory Testing for CMV and Congenital CMV | Cytomegalovirus (CMV) and Congenital CMV Infection | CDC
    https://www.cdc.gov/cytomegalovirus/php/laboratories/index.html
    The enzyme-linked immunosorbent assay is the most common serologic test for measuring antibody to CMV. […] Congenital CMV infection cannot be diagnosed with antibody testing (IgG and IgM). […] The standard laboratory test for diagnosing congenital CMV infection is a PCR on saliva, with a confirmatory test on urine. […] Polymerase chain reaction (PCR) on saliva is the standard laboratory test for diagnosing congenital CMV infection. Urine is usually collected and tested for confirmation. […] Currently, testing of newborns for CMV is not routinely performed, though some states perform targeted CMV testing of newborns who fail the hearing screening. […] A positive test for CMV IgG indicates that a person was infected with CMV at some time during their life but does not indicate when a person was infected.
  • #5 Diagnosis of Cytomegalovirus Infections
    https://pmc.ncbi.nlm.nih.gov/articles/PMC3730495/
    Serological tests are useful for determining whether a patient has had CMV infection in the past, determined by the presence or absence of CMV IgG. […] The detection of IgM antibodies has been used as an indicator of acute or recent infection. […] However, studies have shown poor correlation of results obtained with different commercial kits for IgM testing. […] In addition, assays for IgM antibody lack specificity for primary infection because of false-positive results, because IgM can persist for months after primary infection, and because IgM can be positive in reactivated CMV infections. […] The traditional method for detecting CMV is through conventional cell culture. […] However, this method is slow and requires 2-3 weeks until a result can be reported as negative. […] The antigenemia assay has been commonly used for more than a decade for CMV virus quantification in blood specimens. […] The test not only gives a qualitative result but is also quantitative, correlating closely with viremia and clinical disease severity in immunosuppressed populations.
  • #6
  • #6 Cytomegalovirus – CMV | Choose the Right Test
    https://arupconsult.com/content/cytomegalovirus
    Cytomegalovirus (CMV) can be detected by nucleic acid amplification testing (NAAT), serology, viral culture, and histology. Depending on the patient population, NAAT and serology are generally preferred for diagnosis. […] Quantitative nucleic acid amplification testing (NAAT) is preferred to monitor viral loads and antiviral treatment response in transplant recipients. […] In patients 12 months or older, a positive cytomegalovirus (CMV) immunoglobulin G (IgG) result suggests a past infection, whereas paired IgG results demonstrating seroconversion indicate a recent infection. […] CMV IgM testing cannot be used alone to diagnose primary CMV infection. However, it may be used alongside IgG avidity testing to confirm a current infection. […] Quantitative NAAT (eg, qPCR) for viral DNA in plasma or whole blood is the primary test for detecting CMV infection in immunocompromised patients because this test quantifies viral load, provides rapid and early detection, and offers higher sensitivity than culture.
  • #7 Laboratory Testing for CMV and Congenital CMV | Cytomegalovirus (CMV) and Congenital CMV Infection | CDC
    https://www.cdc.gov/cytomegalovirus/php/laboratories/index.html
    Measurement of CMV IgG in paired samples taken one to three months apart can be used to diagnose primary infection. […] The presence of CMV IgM cannot be used by itself to diagnose primary CMV infection because IgM can also be present during secondary CMV infection. […] IgG avidity assays measure the binding strength between IgG antibodies and virus that can help distinguish a primary CMV infection from a past infection.
  • #8 Cytomegalovirus (CMV) in Pregnancy | ACOG
    https://www.acog.org/clinical-information/physician-faqs/cytomegalovirus-in-pregnancy
    Most adult CMV infections are asymptomatic, which makes recognition of primary infection difficult. Cytomegalovirus infection in adults usually is established by serologic testing. Serum samples collected 3-4 weeks apart, tested in parallel for anti-CMV IgG, are pathognomonic for the diagnosis of primary infection. Seroconversion from negative to positive or a significant increase (greater than fourfold [eg, from 1:4 to 1:16]) in anti-CMV IgG titers is evidence of infection. In addition, the use of IgG avidity assays, which measure the maturity of the IgG antibody, combined with IgM titers allows for improved identification of primary infection (sensitivity of 92%) when compared with standard serial serologic assays. It should be noted that the presence of CMV IgM alone is inadequate for diagnosis of primary infection as there is a 90% false-positive rate.
  • #9 Cytomegalovirus – Serology including Avidity | Public Health Ontario
    https://www.publichealthontario.ca/en/Laboratory-Services/Test-Information-Index/Cytomegalovirus-Serology
    CMV serology is most often indicated for diagnosing acute/recent CMV infection, determining evidence of past (latent) infection, and working up infants with suspected congenital infection. […] When CMV infection is suspected in a pregnant woman and suspected congenital CMV in a newborn infant, order CMV serology and submit a urine sample for CMV PCR testing. On the PHO requisition form, be sure to request both CMV IgM and IgG. Include all relevant clinical information (e.g. pregnancy, suspected congenital infection, etc.), onset date and signs and symptoms. […] CMV IgG avidity is both a sensitive and specific method for identifying pregnant women with recent primary CMV infection and thus at increased risk for vertical CMV transmission. The test is automatically conducted at PHOs laboratory for pregnant patients with a positive CMV IgG and IgM serology test ordered.
  • #10 Diagnosis of Cytomegalovirus Infections
    https://pmc.ncbi.nlm.nih.gov/articles/PMC3730495/
    Polymerase chain reaction (PCR) is a widely available rapid and sensitive method of CMV detection based on amplification of nucleic acids. […] The threshold of the qualitative method needs to be carefully calibrated for preventing over-detection. […] The quantitative PCR (Real-Time PCR) allows for continuous monitoring of immunocompromised individuals to identify patients at risk for CMV disease for preemptive therapy and to determine response to treatment. […] Detection of CMV in the amniotic fluid has been the standard for diagnosis of infection of the fetus. […] With the advent of PCR, detection of CMV DNA in amniotic fluid has shown to improve prenatal diagnosis of congenital CMV infection. […] The highest sensitivity of this assay (90-100%) has been shown when amniotic fluid samples are obtained after the 21st week of gestation and at least 6 weeks after the first positive maternal serologic assay.
  • #11 Decoding human cytomegalovirus for the development of innovative diagnostics to detect congenital infection | Pediatric Research
    https://www.nature.com/articles/s41390-023-02957-9
    An overview of current and emerging diagnostics is provided in Table 2. […] Viral cultures, employing fibroblast monolayers, are also used in clinical laboratories. […] However, viral cultures lack sensitivity and must be maintained for more than 28 days before being considered negative. […] Consequently, the shell vial assay gained popularity in the 1990s and 2000s as the primary test for cCMV because it was a more rapid and sensitive method than culture-based techniques, with results reported in under 48 hours. […] Food and Drug Administration (FDA)-approved commercially available NAAT kits are listed in Table 3. […] While both assays can be used to test saliva swab samples, only Simplexa is also approved to test urine samples. […] Digital PCR (dPCR) maybe a more precise, reproducible, and quantifiable assay than real-time quantitative PCR (qPCR), especially in samples with low viral load.
  • #12 Cytomegalovirus (CMV) Workup: Laboratory Studies, Imaging Studies, Other Tests
    https://emedicine.medscape.com/article/215702-workup
    Qualitative PCR is used to detect CMV in blood and tissue samples. […] Results typically are negative in patients without CMV viremia. […] In transplant recipients, a negative CMV PCR result goes against reactivation, but not infection. […] Quantitative PCR has been used to detect plasma CMV. […] A study of more than 3400 blood specimens from organ transplant recipients tested with CMV PCR and pp65 antigenemia found that quantitative real-time PCR for CMV DNA could be used in lieu of antigenemia for monitoring CMV infection and determining when to initiate preemptive treatment. […] The hallmark of CMV infection is the finding of intranuclear inclusions consistent with herpesvirus infection. CMV infection may be confirmed using in situ hybridization or direct or indirect staining of intranuclear inclusions using CMV-specific antibodies linked to an indicator system.
  • #13 Cytomegalovirus DNA, Qualitative Real-Time PCR, Saliva | Test Summary | Quest Diagnostics Cytomegalovirus DNA, Qualitative Real-Time PCR, SalivaCytomegalovirus DNA, Qualitative Real-Time PCR, Saliva
    https://testdirectory.questdiagnostics.com/test/test-guides/TS_CMV_Saliva/cytomegalovirus-dna-qualitative-real-time-pcr-saliva
    This test is used to diagnose congenital cytomegalovirus infection in newborns. […] Diagnose congenital cytomegalovirus (CMV) infection in newborns ≤21 days old. […] Diagnosing congenital CMV requires direct detection of the virus from saliva, urine, or blood within 21 days of birth. […] Although viral culture has been the gold standard for CMV detection, polymerase chain reaction (PCR) has comparable performance, is faster, and has less strict specimen handling requirements than culture. […] Saliva is easier to collect than blood or urine and is the preferred specimen for congenital CMV PCR testing. […] A „detected” result is consistent with congenital CMV infection. […] A „not detected” result is consistent with the absence of CMV infection.
  • #14 Cytomegalovirus – CMV | Choose the Right Test
    https://arupconsult.com/content/cytomegalovirus
    Cytomegalovirus (CMV) is a common infection among both children and adults. […] When CMV infection is suspected in fetuses, newborns, or transplant recipients, nucleic acid amplification testing (NAAT, such as polymerase chain reaction [PCR]) is commonly used to detect and quantify the patients viral load. […] Serologic testing is useful to assess immunocompetent individuals, pregnant individuals with possible active infection, and prospective transplant donors and recipients during pretransplantation analysis. […] Testing for cytomegalovirus (CMV) infection is appropriate in: Immunocompromised patients who present with febrile illness, hepatitis, or colitis; Pregnant individuals with possible active CMV infection, which may affect the fetus; Neonates with congenital syndromes suggestive of CMV; Prospective transplant donors and prospective or recent transplant recipients; Immunocompetent patients who present with mononucleosis-like illness and have tested negative for Epstein-Barr virus (EBV).
  • #15 Cytomegalovirus (CMV) Workup: Laboratory Studies, Imaging Studies, Other Tests
    https://emedicine.medscape.com/article/215702-workup
    Antigenemia is defined as the detection of the CMV pp65 antigen in leukocytes. […] The pp65 assay is used to detect messenger matrix proteins on the CMV virus, with either immunofluorescence assay or messenger RNA amplification. These proteins typically are expressed only during viral replication. Antigen tests often are the basis for institution of antiviral therapy in transplant recipients and may allow for the detection of subclinical disease in high-risk patients. The assay is sensitive and specific and yields results quickly. […] In immunocompromised patients, low or moderate CMV antigenemia may indicate reactivation or infection. […] It has been reported that the pp65 antigen assay and quantitative CMV PCR yield similar effectiveness in diagnosing and monitoring patients with active CMV infection.
  • #16 Diagnosis of Cytomegalovirus Infections
    https://pmc.ncbi.nlm.nih.gov/articles/PMC3730495/
    The diagnosis of congenital CMV infection is typically made by the demonstration of the virus or viral antigens in newborn samples, urine or saliva. […] The detection of virus in urine and samples obtained from infants within the first two weeks of age is considered the gold standard method for the diagnosis of congenital CMV infection. […] Serological methods are unreliable for the diagnosis of congenital infection. […] Detection of CMV in the saliva and urine of infants is easily accomplished because newborns with congenital CMV infection shed large amounts of virus. […] The rapid culture methods have been shown to have comparable sensitivity and specificity to the standard cell culture assays and the results are available within 24 to 36 hours. […] The CMV antigenemia assay, which detects the pp65 protein in polymorphonuclear leucocytes, is used widely to diagnose CMV infections and monitor treatment in immunocompromised patients. […] However, the utility of this assay in the diagnosis of congenital CMV infection has not been evaluated.
  • #17 Cytomegalovirus – StatPearls – NCBI Bookshelf
    https://www.ncbi.nlm.nih.gov/books/NBK459185/
    Cytomegalovirus (CMV) is a wide-spread virus, with manifestations ranging from asymptomatic to severe end-organ dysfunction in immunocompromised patients with congenital CMV disease. […] CMV infection may be asymptomatic in healthy people, but it can be life-threatening in an immunocompromised patient. […] Laboratory viral identification is the preferred initial test in patients who have suspected CMV infection. […] Although a histopathological diagnosis is a gold standard for diagnosis (by identification of CMV inclusion bodies), quantitative PCR assays are the preferred method for viral detection. […] In immunocompromised patients, the viral load can be undetectable in some cases. […] For this reason, a negative PCR does not exclude CMV infection. […] Serological testing provides essential information regarding serostatus before organ transplantation for risk-stratification of CMV infection.
  • #18 Cytomegalovirus Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/cytomegalovirus
    Cytomegalovirus (CMV) is a double-stranded DNA virus in the herpesvirus family that can cause disseminated or localized end-organ disease in people with HIV with advanced immunosuppression. Most clinical disease occurs in individuals previously infected with CMV experiencing reactivation of latent infection. Infection with a novel strain also may occur. […] End-organ disease caused by CMV occurs in patients with HIV and advanced immunosuppression, typically those with CD4+ T lymphocyte cell (CD4) counts 50 cells/mm3 who are not receiving, adherent to, or responding to antiretroviral therapy (ART). Among those treated with ART who have achieved virologic control, a new diagnosis of CMV end-organ disease is exceedingly rare. […] The diagnosis of CMV end-organ disease is typically made on the basis of the clinical presentation and, when possible, evidence of the virus in tissue. CMV retinitis usually is diagnosed based on recognition of characteristic retinal changes observed through a dilated pupil during an ophthalmoscopic examination performed by an experienced ophthalmologist. Diagnosis in that setting has a 95% positive predictive value.
  • #19 Cytomegalovirus infection pathology
    https://dermnetnz.org/topics/cytomegalovirus-infection-pathology
    Immunohistochemical studies against CMV are a highly specific way of confirming the presence of the virus. […] PCR can also be used.
  • #20 Congenital Cytomegalovirus (CMV) Diagnosis
    https://asm.org/articles/2020/august/congenital-cytomegalovirus-cmv-diagnosis
    Cytomegalovirus (CMV) is the most common congenital infection in the United States, affecting 40,000 infants annually, and is one of the classic perinatal „TORCH” infections (Toxoplasmosis, Other (including syphilis), Rubella, CMV, Herpes simplex virus). […] Treatment of symptomatic congenital CMV can improve long-term outcomes in neonates, so a prompt diagnosis is important. […] In order to accurately identify CMV disease in a neonate, we must understand the role and implications of different diagnostic modalities in the infant and mother. […] Maternal antibody testing plays a role in the diagnosis of primary maternal or congenital CMV infection, but standard IgM and IgG assays have significant limitations for this purpose. […] Suspected congenital CMV infection can be confirmed by PCR testing of amniotic fluid obtained by amniocentesis.
  • #21 Congenital Cytomegalovirus Infection: Update on Diagnosis and Treatment
    https://www.mdpi.com/2076-2607/8/10/1516
    Congenital cytomegalovirus (cCMV) infection is the most common congenital viral infection and is the leading non-genetic cause of sensorineural hearing loss (SNLH) and an important cause of neurodevelopmental disabilities. […] Despite its prevalence and morbidity among the neonatal population, there is not yet a standardized diagnostic test and therapeutic approach for cCMV infection. […] Currently, we recommend using a PCR assay in blood, urine, and saliva in neonates with suspected cCMV infection. […] In the case of symptomatic cCMV, we actually recommend treatment with oral valganciclovir for a duration of 12 months. […] Treatment with antiviral drugs is not routinely recommended for neonates with the mildly symptomatic disease at birth, for neonates under 32 weeks of gestational age, or for infants more than 30 days old because of insufficient evidence from studies.
  • #22 Society for Maternal-Fetal Medicine Consult Series #39: Diagnosis and antenatal management of congenital cytomegalovirus infection – SMFM Publications and Clinical Guidelines
    https://publications.smfm.org/publications/585-society-for-maternal-fetal-medicine-consult-series-39/
    Congenital cytomegalovirus (CMV) is the most common viral infection, affecting nearly 40,000 infants each year in the United States. The purpose of this document is to review diagnosis of primary maternal CMV infection, diagnosis of fetal CMV infection, and whether antenatal therapy is warranted. We recommend the following: (2) for women suspected of having primary CMV infection in pregnancy, we recommend that diagnosis should be either by IgG seroconversion or with positive CMV IgM, positive IgG, and low IgG avidity (grade 1B); (3) amniocentesis is the best option as a prenatal diagnostic tool to detect fetal congenital CMV infection, performed 21 weeks of gestation and 6 weeks from maternal infection (grade 1C); (4) we do not recommend routine screening of all pregnant women for evidence of primary CMV infection at this time (grade 1B); and (5) we do not recommend antenatal treatment with ganciclovir or valacyclovir; and we recommend that any antenatal therapy, either with antivirals or CMV hyperimmune globulin, should only be offered as part of a research protocol (Best Practice).
  • #23 Cytomegalovirus (CMV) | Causes, Symptoms, and Treatment
    https://patient.info/doctor/cytomegalovirus
    Cytomegalovirus (CMV) is a member of the herpesvirus family. Infection is worldwide and usually asymptomatic. CMV may cause a mononucleosis infection in healthy individuals but can cause severe illness in congenital infection and in an immunocompromised host. […] CMV can be detected by culture, serology, antigen assays, PCR and cytopathology. […] The diagnosis of maternal primary CMV infection in pregnancy is based on positive CMV IgG in a pregnant woman who was previously seronegative or on detection of specific IgM antibody associated with low IgG avidity. […] PCR is the fastest and most sensitive method used to detect CMV in blood and tissue samples. It is positive before the antigenaemia test in patients with viraemia who have received transplants. […] Immunocompetent patients usually require no treatment other than general advice to increase fluids and treat fever. However, patients with immunodeficiency require intensive antiviral treatment.
  • #24 Cytomegalovirus (CMV) in Pregnancy | ACOG
    https://www.acog.org/clinical-information/physician-faqs/cytomegalovirus-in-pregnancy
    After detection of maternal infection or suspected fetal infection based on ultrasound findings, CMV can be detected in the amniotic fluid of infected fetuses by either culture or PCR. Fetal blood sampling, which is less sensitive than amniotic fluid testing and carries additional risks for the fetus, is not warranted. The sensitivity of CMV amniotic fluid culture ranges from 70% to 80% compared with a sensitivity of 78-98% for PCR (specificity of 92-98%). In the setting of maternal CMV infection, the sensitivity of amniotic fluid testing for prenatal diagnosis of congenital CMV infection is increased by waiting 6-8 weeks or longer after infection or after 21 weeks of gestation. Although a positive culture of PCR is highly predictive of congenital infection, the detection of CMV in amniotic fluid does not predict the severity of congenital CMV infection.
  • #25 Decoding human cytomegalovirus for the development of innovative diagnostics to detect congenital infection | Pediatric Research
    https://www.nature.com/articles/s41390-023-02957-9
    The gold standard for diagnosing fetal HCMV infection is the detection of viral DNA in the amniotic fluid via amniocentesis after the 21st week of gestation and at least six weeks after a maternal lytic infection. […] Detecting cytomegalovirus in culture or HCMV DNA in the blood, urine, saliva, or cerebrospinal fluid (CSF) within the first three weeks of life is necessary to diagnose a congenital infection. […] Technologies used to identify HCMV have evolved over the last half-century, and nucleic acid amplification-based tests [i.e., polymerase chain reaction (PCR)] have become the current standard for routine sample testing in multiple tissue matrices. […] Emerging diagnostics promise the ability to not only rapidly identify HCMV DNA from multiple tissue matrices but also provide information regarding the cytomegalovirus strain(s) and antiviral resistance pattern(s) through ultrasensitive detection of single nucleotide-level modifications of the viral genome that are simultaneously analyzed by artificial intelligence algorithms.
  • #26 About Cytomegalovirus | Cytomegalovirus (CMV) and Congenital CMV Infection | CDC
    https://www.cdc.gov/cytomegalovirus/about/index.html
    Healthcare providers can order blood tests to identify CMV infection in adults who have symptoms. […] However, blood is not the best fluid to test newborns with suspected CMV infection. […] Saliva or urine tests are preferred for newborns. These tests must be done within 2 to 3 weeks of birth to confirm if the baby has congenital CMV.
  • #27 Cytomegalovirus (CMV) Infection: Causes & Symptoms
    https://my.clevelandclinic.org/health/diseases/21166-cytomegalovirus
    Healthcare providers use blood, urine (pee) or saliva (spit) tests to diagnose CMV. […] Your healthcare provider may test you for CMV if you have a weakened immune system. Your child’s healthcare provider may test them in their first few weeks of life if they have symptoms of congenital CMV. […] To diagnose CMV, your healthcare provider may order some or all of these tests: Blood tests. A provider usually uses blood tests to diagnose CMV in adults. Your provider will use a needle to take blood from your vein. They’ll send it to a lab to look for signs of infection. […] Urine tests. A provider might use a urine (pee) test to diagnose CMV in a newborn baby. Your baby’s provider will either collect a sample or give you instructions on how to collect one. They’ll send the sample to a lab to look for signs of CMV. […] Saliva tests. A provider might use a saliva (spit) test to diagnose CMV in a newborn baby. Your baby’s provider will use a stick with a soft tip (swab) to gently collect a small amount of spit from the inside of your baby’s mouth. They’ll send the sample to a lab to look for signs of CMV.
  • #28 Cytomegalovirus (CMV) and Congenital CMV Infection
    https://dph.illinois.gov/topics-services/diseases-and-conditions/diseases-a-z-list/diseases/cmv.html
    Blood tests can be used to diagnose CMV infections in adults who have symptoms. However, blood is not the best fluid to test newborns with suspected CMV infection. Tests of saliva or urine are preferred for newborns. […] Congenital CMV infection can be diagnosed by testing a newborn babys saliva, urine, or blood. Such specimens must be collected for testing within two to three weeks after the baby is born in order to confirm a diagnosis of congenital CMV infection.
  • #29 Cytomegalovirus (CMV) – congenital and postnatal infection | NHSGGC
    https://clinicalguidelines.scot.nhs.uk/ggc-paediatric-guidelines/ggc-paediatric-guidelines/neonatology/cytomegalovirus-cmv-congenital-infection/
    CMV infection should be considered if there is: […] The diagnosis of congenital infection is made by PCR testing of body fluids in the first 3 weeks of life but ideally within the first 2 weeks. […] Both urine and salivary swabs should be tested by PCR where CMV is suspected. […] If CMV infection is diagnosed after 3 weeks of age it may be unclear whether the infection is congenital. […] The sensitivity for bloodspot testing is variable and false negatives can occur. […] Treatment may still be considered in infants with evidence of CNS involvement or who have severe focal organ disease, in whom the timing of infection is uncertain but this should be discussed with the paediatric infectious disease team. […] Ganciclovir 6mg/kg twice daily by intravenous infusion (central line) […] Valganciclovir 16mg/kg/dose twice daily by mouth (unless renal impairment)
  • #30 Congenital Cytomegalovirus Infection: Update on Screening, Diagnosis and Treatment (Scientific Impact Paper No. 56) | RCOG
    https://www.rcog.org.uk/guidance/browse-all-guidance/scientific-impact-papers/congenital-cytomegalovirus-infection-update-on-screening-diagnosis-and-treatment-scientific-impact-paper-no-56/
    Cytomegalovirus (CMV) is the most common cause of viral infection in newborn babies, and affects 1 in 200 of all live born infants in high-income countries; and 1 in 71 in low- and middle-income countries. It is a major cause of hearing loss and brain damage. […] The UK National Screening Committee recommends against universal antenatal or newborn screening for CMV. Testing for CMV is usually offered only to women who develop symptoms of influenza, glandular fever or hepatitis (liver inflammation) during pregnancy, or for those whom a routine ultrasound scan detects fetal anomalies that suggests possible CMV infection. […] Babies with CMV infection at birth may have jaundice, a rash, enlarged liver or spleen, a small brain, or be small for their gestational age. Around 1 in 8 babies born with CMV infection will have clinically detectable signs at birth. The rest will not have any features detectable by clinical examination alone. Therefore, all infants with CMV infection at birth should be followed up at a minimum of up to 2 years of age or later, depending upon the disease status, to check hearing and brain development.
  • #31 Update on congenital cytomegalovirus infection: Prenatal prevention, newborn diagnosis, and management | Canadian Paediatric Society
    https://cps.ca/documents/position/update-on-congenital-cytomegalovirus-infection-prenatal-prevention-newborn-diagnosis-and-management
    Infants born to mothers with suspected or proven CMV during pregnancy […] should undergo CMV testing and clinical and laboratory evaluation to determine disease classification. […] A negative urine or saliva CMV test should trigger investigations for other congenital infectious or genetic causes. […] Newborns who fail their newborn hearing screen (NBHS) are also being tested for CMV. […] Although universal screening would (ideally) optimize detection of cCMV, consensus is needed concerning the optimal specimen to use for early newborn screening. […] When testing has confirmed cCMV, symptomatic infants require ophthalmological and hearing evaluation as well as head imaging. […] All infants with symptomatic cCMV and asymptomatic infants with isolated hearing loss should be referred to an infectious disease specialist. […] Early laboratory identification of infants with cCMV (within the first 21 days after birth) is essential to determine disease severity and initiate antiviral therapy in moderate to severe cases.
  • #32 Congenital Cytomegalovirus Infection: Update on Diagnosis and Treatment
    https://www.mdpi.com/2076-2607/8/10/1516
    A reliable, rapid, and possibly not expensive method to screen newborns for congenital CMV infection is urgently needed. […] Virus isolation by culture from urine or saliva has long been the standard method for diagnosing cCMV infection. […] Since PCR exhibits high sensitivity in both saliva and urine samples, postnatal diagnosis of cCMV is preferably performed via real-time polymerase chain reaction (PCR). […] The role of the viral load (VL) at birth has been recently investigated to determine whether it could be a reliable marker of disease severity or could predict long-term outcomes; its role in identifying children who will develop complications in their first years of life has also been studied. […] The current literature demonstrates a higher baseline VL among children with moderate-to-severe symptoms compared to asymptomatic patients.
  • #33 Cytomegalovirus (CMV) Workup: Laboratory Studies, Imaging Studies, Other Tests
    https://emedicine.medscape.com/article/215702-workup
    In congenital CMV disease, laboratory abnormalities may include abnormal transaminases, bilirubin and platelet levels. To diagnose congenital CMV infection, testing should be performed within the first 3 weeks of life, because testing past this period does not differentiate intrauterine from perinatal acquisition of CMV infection. Saliva CMV PCR is the preferred diagnostic test for newborn congenital CMV screening, because high viral loads are shed in both urine and saliva in infants with congenital CMV. Due to some false-positive results in breastfeeding patients, obtaining a sample of saliva at least 1 hour after could avoid potential contamination with CMV from human milk. Other recommended tests include polymerase chain reaction (PCR) in blood and urine as well. […] The prognostic value of CMV viral load in neonatal samples, especially with asymptomatic infection, is unclear. The role of virus burden in the peripheral blood, urine, and saliva in disease and outcome needs further study.
  • #34 Cytomegalovirus – CMV | Choose the Right Test
    https://arupconsult.com/content/cytomegalovirus
    Testing for CMV infection in pregnant individuals generally occurs after concerning ultrasound findings. […] When primary CMV infection is suspected during pregnancy, serologic assays are the main tests used for evaluation. […] In newborns, NAAT using saliva is initially performed to identify CMV infection. […] Following transplantation, quantitative NAAT performed on plasma or whole blood is recommended to screen for CMV infection in at-risk individuals, guide preemptive treatment, diagnose a current infection, and monitor response to antiviral therapies. […] Testing for CMV resistance to antivirals may be warranted in certain situations and is performed with genotypic methods. […] When antiviral resistance is suspected, consensus guidelines recommend testing for causative variants in the UL97 and UL54 genes, at a minimum.
  • #35 Cytomegalovirus (CMV) Genotype | Test Summary | Quest Diagnostics HLA-B27HLA-B27
    https://testdirectory.questdiagnostics.com/test/test-guides/TS_CMV_Genotype/cytomegalovirus-cmv-genotype
    This test is used to detect antiviral resistance in patients with CMV infection. […] Clinical use […] Detect antiviral resistance in patients with cytomegalovirus (CMV) infection. […] According to the same guidelines, suspected antiviral resistance should be confirmed by genotypic resistance testing, which involves testing for CMV mutations that are known to confer resistance. […] Quest Diagnostics offers 3 genotypic tests for CMV drug resistance that detect mutations in the UL54, UL56, and/or UL97 genes. […] The genotypic tests offered by Quest use next-generation sequencing (NGS), which is more sensitive than traditional Sanger sequencing, potentially allowing resistance to be detected earlier. […] Individuals suitable for testing […] Patients with suspected refractory or resistant CMV infection. […] Genotypic tests for CMV drug resistance have the following limitations: […] Test results do not include mutations that are present in <15% of the viral population. [...] Therefore, it is important to detect resistance as quickly and accurately as possible for proper management of CMV infection.
  • #36 Cytomegalovirus (CMV) Workup: Laboratory Studies, Imaging Studies, Other Tests
    https://emedicine.medscape.com/article/215702-workup
    The diagnosis of CMV pneumonia can be suggested by chest radiography findings, but these findings cannot be used to differentiate between other common causes of pneumonia in immunocompromised hosts. A chest radiograph finding consistent with pneumonia and a BAL result that is CMV positive is a common method for diagnosis. […] If resistant CMV infection is suspected (refractory to IV ganciclovir or valganciclovir therapy), an alternative therapy should be used based on genetic resistance. UL54 mutation is associated with ganciclovir resistance and a cross-resistance with cidofovir. UL97 mutation is also associated with ganciclovir resistance. […] The diagnosis of CMV infection is critical for appropriate management and treatment strategies in affected patients.
  • #37 Comprehensive CMV Testing: Assessing, Treating, and Managing Cytomegalovirus
    https://www.eurofins-viracor.com/news-and-events/posts/2023/july/comprehensive-cmv-testing-assessing-treating-and-managing-cytomegalovirus/
    Viral load testing measures the quantity of CMV in a patient’s blood, urine, or other body fluids. It provides a quantitative assessment of viral replication and helps monitor disease progression and response to treatment. […] Comprehensive CMV testing facilitates early detection of CMV infections, allowing for timely intervention. This is particularly crucial in high-risk populations, such as pregnant women and immunocompromised patients. Early identification of CMV in pregnant women enables appropriate counseling, monitoring, and potential interventions to reduce the risk of vertical transmission and associated fetal complications. […] Regular monitoring of CMV through comprehensive testing allows healthcare providers to detect viral reactivation or new infections early on. This enables proactive management, including antiviral treatment initiation or adjustment, to prevent or minimize CMV-related complications and improve overall patient outcomes.
  • #38 Diagnosis of Cytomegalovirus Infections
    https://pmc.ncbi.nlm.nih.gov/articles/PMC3730495/
    Quantitative PCR has also been proven to be useful in the monitoring of these patient groups for their response to antiviral therapy. […] However, the usefulness of PCR or other nucleic acid amplification assays in the diagnosis of congenital CMV infection has not been defined. […] The reasons for the low sensitivity of DBS PCR in identifying infants with congenital CMV infection are not entirely clear. […] These findings underscore the need for further evaluation of high throughput methods performed on saliva or other samples that can be adapted to large-scale newborn CMV screening. […] The development of saliva PCR assays could have the potential to adapt these methods in a high throughput fashion to screen large number of newborns for congenital CMV infection.
  • #39 Cytomegalovirus Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/cytomegalovirus
    Detection of CMV DNA in CSF or vitreous or aqueous humor specimens is highly suggestive that CMV is the cause of ocular disease. […] Blood tests to detect CMV by antigen detection, culture, or PCR are not recommended for diagnosis of CMV end-organ disease because of their poor positive predictive value in people with advanced AIDS. […] The presence of serum antibodies to CMV, in and of itself, does not establish the presence of CMV disease, because a large proportion of the general population has been exposed to CMV and is seropositive. However, a negative immunoglobulin G (IgG) antibody level indicates that CMV is unlikely to be the cause of the disease process. […] CMV end-organ disease is best prevented using ART to maintain the CD4 count 100 cells/mm3. […] The primary method for preventing severe CMV disease is recognizing the early manifestations of the disease and instituting proper therapy.
  • #40 Cytomegalovirus (CMV): Practice Essentials, Background, Pathophysiology
    https://emedicine.medscape.com/article/215702-overview
    CMV GI disease is defined as the combination of symptoms of the upper and lower GI tract, mucosal lesions visible on endoscopy, and detection of CMV via culture, histopathology, immunohistochemistry, or in situ hybridization. […] CMV CNS disease is defined as CNS symptoms in combination with CMV detection in CSF (culture, PCR) or brain biopsy tissue (culture, histopathology, immunohistochemistry, in situ hybridization). […] CMV nephritis is defined as CMV detection in combination with a renal biopsy showing CMV-associated changes in the setting of renal failure. […] In general, it is better to avoid this term in stem cell transplant recipients, as other viruses (eg, HHV-6) also can cause fever and bone marrow suppression. However, in solid organ transplant recipients, CMV syndrome is better defined: fever (38C) for at least 2 days within a 4-day period, CMV detection in blood, and either neutropenia or thrombocytopenia. […] CMV infection has been associated with acute graft verus host disease in bone marrow transplant recipients.
  • #41 Cytomegalovirus (CMV): Practice Essentials, Background, Pathophysiology
    https://emedicine.medscape.com/article/215702-overview
    CMV has been detected via culture, serologies, antigen assays, polymerase chain reaction (PCR), and cytopathology. In the transplant population, antigen assays or PCR is used (sometimes in conjunction with cytopathology) for diagnosis and treatment determinations. […] The diagnosis of CMV pneumonia can be suggested by chest radiography findings, but these findings cannot be used to differentiate between other common causes of pneumonia in immunocompromised hosts. A chest radiograph finding consistent with pneumonia and a bronchoalveolar lavage (BAL) result that is CMV positive is a common method for diagnosis. […] Infection is defined as isolation of CMV, its viral proteins, or its nucleic acid from any tissue sample or body fluid. […] CMV hepatitis is defined as elevated bilirubin and/or liver enzymes levels in combination with the detection of CMV in the absence of other causes for hepatitis.
  • #42 Cytomegalovirus Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/cytomegalovirus
    The optimal duration of therapy and the role of oral valganciclovir have not been established. […] The diagnosis of CMV pneumonitis requires consistent clinical and radiological findings (i.e., diffuse pulmonary interstitial infiltrates, fever, and cough or dyspnea), identification of multiple CMV inclusion bodies in lung tissue or cytology, and the absence of any other pathogens that are more commonly associated with pneumonitis.
  • #43 Cytomegalovirus (CMV) Tests – Testing.com
    https://www.testing.com/tests/cytomegalovirus-cmv-tests/
    Cytomegalovirus (CMV) testing detects antibodies in the blood that the body produces in response to the infection or detects CMV directly. […] Cytomegalovirus (CMV) testing is not used to test everyone for a CMV infection. It may be used help diagnose an active, reactivated, or past CMV infection in certain cases, such as: […] A positive CMV IgG and IgM when you have symptoms means it is likely that you have been exposed to CMV for the first time recently or a previous CMV infection has been reactivated. […] A positive CMV DNA test may mean CMV is present and you have, or the newborn tested, has an active infection. […] When used to monitor effectiveness of treatment, decreasing levels of CMV (viral loads) mean you are responding to antiviral treatment. […] (Updated 2010 December 6) Cytomegalovirus (CMV) and Congenital CMV Infection, Interpretation of Laboratory Tests. Centers for Disease Control and Prevention [On-line information]. Available online at https://www.cdc.gov/cmv/clinical/lab-tests.html. Accessed February 2011.
  • #44 Cytomegalovirus – Serology including Avidity | Public Health Ontario
    https://www.publichealthontario.ca/en/Laboratory-Services/Test-Information-Index/Cytomegalovirus-Serology
    CMV IgG testing will be performed on all requests for CMV immunity serology. […] CMV IgG and IgM testing will only be performed on diagnostic requests when the following clinical information is provided on the General Test Requisition Form indicating acute/recent infection, vaccination history, relevant signs, symptoms, and/or clinical history, and onset date. This information assists in providing the correct interpretation of results. […] CMV IgG avidity will be performed automatically in a pregnant patient with CMV IgG and IgM positive. […] The CMV IgG and IgM tests are performed using Chemiluminescent Immunoassay (CLIA) technology on the Diasorin LIAISON XL for the qualitative determination of IgG and IgM antibodies to human cytomegalovirus (hCMV) in human serum. […] The LIAISON CMV IgM assay is intended to be used as an aid in the diagnosis of acute CMV infection. […] A positive result should be interpreted together with clinical findings and results from other serological tests. The results obtained from this assay are not diagnostic proof of the presence or absence of a disease.
  • #45 Cytomegalovirus (CMV) Infection – Infections – Merck Manual Consumer Version
    https://www.merckmanuals.com/home/infections/herpesvirus-infections/cytomegalovirus-cmv-infection
    In newborns, the diagnosis is usually made by sending a sample of urine to a laboratory to grow (culture) and identify the virus. […] Blood tests that detect antibodies to CMV can confirm a new infection if the person did not previously have these antibodies. […] The presence of CMV in body fluids and tissues does not always indicate disease and may merely represent viral shedding. CMV disease can be caused by reactivation of the virus, as in people with a weakened immune system. In these people, a biopsy of affected tissues is often necessary to confirm CMV disease. […] Blood tests to estimate how many viruses are present may also be done and may be helpful because an elevated or rising CMV viral load is often highly suggestive of invasive disease.
  • #46 Congenital Cytomegalovirus infection: advances and challenges in diagnosis, prevention and treatment | Italian Journal of Pediatrics | Full Text
    https://ijponline.biomedcentral.com/articles/10.1186/s13052-017-0358-8
    Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, with an estimated incidence in developed countries of 0.60.7% of all live births. […] Despite its health, social, and economic burden, congenital CMV infection often goes undetected at birth because the majority of affected infants are asymptomatic or present with symptoms that are sufficiently nonspecific that they do not prompt clinicians to suspect CMV infection. Screening programs, both in pregnant women and in newborns, have not been developed or implemented. […] Traditionally, virus isolation from urine or saliva in tissue cultures has been the standard method for diagnosing congenital CMV infection. […] The optimization of the real-time polymerase chain reaction (PCR) technology has led to important advances in the diagnostic possibilities, since it is amenable to automation, is low-cost, and is unlikely to be affected by sample storage and transport conditions.
  • #47 Cytomegalovirus (CMV) in Pregnancy | ACOG
    https://www.acog.org/clinical-information/physician-faqs/cytomegalovirus-in-pregnancy
    Routine serologic screening of pregnant individuals for CMV is not recommended. The vast majority (approximately 90%) of positive IgM results are false positive and likely due to cross-reactivity with other non-CMV antibodies. The limitations of maternal IgM antibody screening in differentiating primary from recurrent infection also make the results difficult to use in counseling patients about fetal risk. In addition, maternal immunity does not eliminate the possibility of fetal infection. The lack of a vaccine for prevention or a proven treatment to prevent congenital transmission further diminishes the potential benefit of universal screening.
  • #48 Update on congenital cytomegalovirus infection: Prenatal prevention, newborn diagnosis, and management | Canadian Paediatric Society
    https://cps.ca/documents/position/update-on-congenital-cytomegalovirus-infection-prenatal-prevention-newborn-diagnosis-and-management
    Cytomegalovirus (CMV) is the leading cause of congenital infection and the most common cause of non-genetic sensorineural hearing loss (SNHL) in childhood. […] The prompt identification of infected infants allows early initiation of surveillance and management. A multidisciplinary approach to management is critical to optimize outcomes in affected infants. […] This practice point focuses on the diagnosis of cCMV in infants, and outlines current management strategies. Universal infant screening for cCMV is being considered in some countries, and in Canada, has already commenced in Ontario. […] Diagnostic tests for cCMV rely on directly identifying the virus in an infants body fluids before 21 days of age. […] Testing using CMV rapid viral cultures (sensitivity 92%, specificity 100%) or PCR-based assays (sensitivity 95%, specificity 98%) of the infants urine (preferable method and a bag specimen is adequate) or saliva should be done.
  • #49 Decoding human cytomegalovirus for the development of innovative diagnostics to detect congenital infection | Pediatric Research
    https://www.nature.com/articles/s41390-023-02957-9
    A critical need remains for developing a highly sensitive, inexpensive, and rapid diagnostic to identify neonates with cCMV. […] More extensive population-based studies and universal screening initiatives are required to correctly define the effects of cCMV and determine if any intervention would prevent or attenuate observed impairments once detected.
  • #50 Cytomegalovirus (CMV)
    https://diagnostics.roche.com/gb/en/article-listing/health-topics/infectious-diseases/cytomegalovirus.html
    Calibrating and reporting CMV DNA viral load in International Units per millilitre (IU/mL) has improved the harmonisation of results from different laboratories. […] Despite this, management of active CMV infection is still hampered by the limited commutability of results between reference materials and clinical samples, and a subsequent lack of evidence-based viral load thresholds. […] With improved techniques and Roche diagnostics’ continuous monitoring of the virus, CMV lab tests for infections in newborn children are almost 90% accurate.
  • #51 Cytomegalovirus (CMV) Tests: MedlinePlus Medical TestLock
    https://medlineplus.gov/lab-tests/cytomegalovirus-cmv-tests/
    Cytomegalovirus (CMV) tests check for signs of CMV in your blood, sputum, or other body fluids. CMV tests help diagnose a current, reactivated, or past CMV infection in people at risk for health complications. […] You may need testing if you have a weakened immune system or are pregnant and have the following symptoms: Swollen lymph nodes („swollen glands”), Sore throat, Fever, Fatigue, Weakness, Muscle aches, Headache. […] The test result can show whether you have ever had a CMV infection. But the tests can’t show if it’s a current, past, or reactivated infection. […] CMV testing can help those at risk for complications get the treatment they need. While there is no cure for CMV, antiviral medicines and other treatments may reduce your symptoms and improve outcomes.
  • #52
    https://www.healthychildren.org/English/health-issues/conditions/infections/Pages/Cytomegalovirus-CMV-Infections.aspx
    Cytomegalovirus (CMV) infection is generally mild. Most newborns with congenital CMV infection have no signs of illness at birth and remain well. However, it may lead to hearing and developmental differences in infancy and childhood. […] To diagnose a CMV infection, a pediatrician or other health care clinician may order lab tests of urine, saliva, blood or other body fluids. […] Medical treatment is recommended for newborns with congenital CMV who have signs of illness. Even with treatment, babies with CMV infection may have or develop hearing changes or other developmental challenges. […] Serious CMV infections in children with immune system compromise, such as those with HIV infection or an organ transplant, can be treated with a medicine called ganciclovir or valganciclovir. This medicine is also used to treat newborns with moderate or severe congenital CMV disease.
  • #53 Congenital Cytomegalovirus | Boston Children’s Hospital
    https://www.childrenshospital.org/conditions/congenital-cytomegalovirus
    Cytomegalovirus (CMV) is a virus related to the herpes virus group of infections. Like herpes, it is inactive at times, but it is incurable and is a lifetime infection. […] If we find that your baby has been infected with CMV, treatment should begin right away to ensure that the condition has a minimal effect on her health. […] Here at Boston Children’s, physicians in our Division of Infectious Diseases care for children and adolescents with a variety of infections, including treating children with congenital cytomegalovirus. […] The most commonly used treatments for congenital CMV are called ganciclovir and valganciclovir. […] Most CMV infections in the mother are not diagnosed because the virus produces few symptoms. However, the virus can be detected using the following tests: blood test: checking for antibodies in the mother’s bloodstream, swab culture: taking a sample with a cotton swab from the throat of the mother or the baby, urine test: checking the urine of the mother or the baby.
  • #54 Congenital Cytomegalovirus Infection: Update on Screening, Diagnosis and Treatment (Scientific Impact Paper No. 56) | RCOG
    https://www.rcog.org.uk/guidance/browse-all-guidance/scientific-impact-papers/congenital-cytomegalovirus-infection-update-on-screening-diagnosis-and-treatment-scientific-impact-paper-no-56/
    All babies born to women with confirmed or suspected CMV infection should be tested for CMV with a urine or saliva sample within the first 21 days of life. […] In newborns with symptomatic CMV infection at birth, treatment with antiviral medicine (valganciclovir or ganciclovir) can reduce hearing loss in 5 out of 6 babies, and improve long-term brain development outcomes in some.
  • #55 Congenital Cytomegalovirus infection: advances and challenges in diagnosis, prevention and treatment | Italian Journal of Pediatrics | Full Text
    https://ijponline.biomedcentral.com/articles/10.1186/s13052-017-0358-8
    At this time and with the available methods, CMV testing with DBS real-time PCR therefore is unsuitable for the purpose of CMV screening, and its main utility remains the retrospective diagnosis of congenital CMV infection in children who present with delayed-onset sequelae. […] Unlike the DBS specimens, real-time PCR assay on saliva swabs from the CHIMES study produced excellent results, both for air dried swabs and for swabs sent to the laboratory in viral transport medium. […] The excellent analytical sensitivity and the ease of saliva collection in neonates make this specimen advantageous for neonatal CMV screening. […] The advances in neonatal antiviral therapy for symptomatic infants have been substantial in the last years. […] In 2003 the Collaborative Antiviral Study Group (CASG) of the National Institute of Allergy and Infectious Diseases (NIAID) published the results of the first phase III, randomized, controlled trial of 6-week GCV therapy versus no treatment, to determine the effects of GCV on hearing function in symptomatic infants with CNS involvement.
  • #56 Cytomegalovirus Disease: Adult and Adolescent OIs | NIH
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/cytomegalovirus
    The therapeutic approach to CMV retinitis should be individualized based on tolerance of systemic medications, prior exposure to anti-CMV drugs, and possibly the location of lesions. […] Oral valganciclovir, intravenous (IV) ganciclovir, or IV ganciclovir induction followed by oral valganciclovir maintenance are first-line therapies for treating CMV retinitis. […] Treatment with systemic anti-CMV therapy, such as oral valganciclovir for the first 3 to 6 months until ART has induced immune recovery, is beneficial. […] For patients who have colitis or esophagitis, many HIV specialists recommend anti-CMV therapy for 21 to 42 days or until signs and symptoms have resolved. IV ganciclovir generally is the therapy of choice and can be switched to oral valganciclovir once the patient can tolerate and absorb oral medications.
  • #57 Comprehensive CMV Testing: Assessing, Treating, and Managing Cytomegalovirus
    https://www.eurofins-viracor.com/news-and-events/posts/2023/july/comprehensive-cmv-testing-assessing-treating-and-managing-cytomegalovirus/
    Diagnostic testing is essential for monitoring the response to antiviral treatment in CMV-infected individuals. Serological testing plays a crucial role in assessing a patient’s immune response to CMV. It detects the presence of antibodies, specifically immunoglobulin G (IgG) and immunoglobulin M (IgM), against CMV in the blood. IgM antibodies indicate recent or active infection, while the presence of IgG antibodies suggests past exposure or immunity. Serological testing helps determine the patient’s CMV status and provides valuable information for risk assessment and management. […] Molecular tests, such as polymerase chain reaction (PCR), are highly sensitive and specific for detecting CMV DNA or RNA in patient samples. These tests can identify active CMV infections even before symptoms manifest or when viral loads are low.
  • #58 Cytomegalovirus (CMV) – congenital and postnatal infection | NHSGGC
    https://clinicalguidelines.scot.nhs.uk/ggc-paediatric-guidelines/ggc-paediatric-guidelines/neonatology/cytomegalovirus-cmv-congenital-infection/
    The aim with this group of patients is to reduce the viral load by 1-2 logs. […] If no response is seen advice should be sought from the consultant Virologist or Infectious Disease specialist. […] The indication for treatment in symptomatic pCMV is to suppress active viraemia and prevent destructive end-organ disease rather than to alter the course of a chronic infection. […] Ganciclovir IV via central access if unable to tolerate feeds 6mg/kg twice daily […] Valganciclovir 16mg/kg twice daily if/when able to tolerate feeds, transition when on 50% enteral feeds and tolerating. […] There is evidence that anti-viral treatment is beneficial in improving, preventing deterioration or maintaining hearing in some cases of congenital CMV.
  • #59 Congenital Cytomegalovirus (CMV) Infection: Diagnosis, Testing, and Treatment Advances | Meridian Bioscience
    https://www.meridianbioscience.com/diagnostics-blog/breaking-down-congenital-cytomegalovirus-insights-into-diagnosis-and-treatment/
    Congenital CMV Testing: Newborns suspected of having congenital CMV can undergo saliva, urine or blood tests within the first three weeks of life to accurately diagnose the infection. […] Recent developments in CMV diagnostic tests aim to enhance their sensitivity, specificity, and accessibility. […] Diligent screening in newborns and pregnant women for early detection remains a cornerstone of managing congenital CMV, ensuring that affected infants receive the care and support they need to thrive.
  • #60 Cytomegalovirus – StatPearls – NCBI Bookshelf
    https://www.ncbi.nlm.nih.gov/books/NBK459185/
    However, it is not recommended for the diagnosis of acute infection. […] Testing for CMV resistance is now common in transplant centers. […] Resistance to ganciclovir has been noted in many transplant patients and makes treatment difficult. […] Several antiviral agents have been approved for the treatment of CMV (cidofovir, foscarnet, ganciclovir, valganciclovir). […] However, antiviral therapy should be considered in severe cases of CMV mononucleosis, CMV infection, and CMV disease in immunocompromised patients. […] The use of antiviral therapy is not without risk. […] Patients without CMV infection who receive organ transplants from CMV-infected donors should receive prophylactic treatment with valganciclovir or ganciclovir, and regular serological monitoring; if treated, the early establishment of a potentially life-threatening infection can be avoided. […] A definitive diagnosis is rarely required in immunocompetent patients. […] The diagnosis of CMV cannot be made solely based on clinical examination.
  • #61 Decoding human cytomegalovirus for the development of innovative diagnostics to detect congenital infection | Pediatric Research
    https://www.nature.com/articles/s41390-023-02957-9
    Therefore, when utilizing NAAT, clinicians should consider the following when making clinical management decisions the: (1) type of specimen (i.e., urine, saliva, whole blood, or plasma), (2) limits of detection and quantification chosen by the clinical laboratory, (3) linear range of the assay, and (4) reproducibility within the institution. […] CMV derived its name cytomegalovirus from changes in the host cell following viral infection. […] HCMV can be identified by hematoxylin and eosin (HE) staining of tissues, resulting in the pathognomonic appearance of cytomegalic cells with owl eye inclusions. […] While routine monitoring of viral burden is not currently advocated for neonates with moderate to severe symptomatic cCMV disease treated with ganciclovir (GCV) or valganciclovir (VGCV) for less than six months, recent investigations have reported antiviral resistance with prolonged courses (6 months).