Zespół oddechowy bliskiego wschodu (mers)
Diagnostyka i diagnoza

Zespół oddechowy bliskiego wschodu (MERS) to ciężka infekcja układu oddechowego wywoływana przez koronawirusa MERS-CoV, zdiagnozowana po raz pierwszy w 2012 roku. Diagnostyka opiera się na wywiadzie epidemiologicznym (pobyt lub kontakt z regionami endemicznego występowania w ciągu ostatnich 14 dni), objawach takich jak gorączka, kaszel i duszność oraz na badaniach laboratoryjnych. Złotym standardem jest real-time RT-PCR, wykrywający co najmniej dwa specyficzne geny wirusa (upE, ORF1a, ORF1b, N) w próbkach z dróg oddechowych, z preferencją dla materiału z dolnych dróg oddechowych (aspirat tchawiczny, plwocina, płyn z płukania oskrzelowo-pęcherzykowego). Dodatkowo, testy serologiczne i szybkie testy antygenowe mogą wspierać diagnostykę, zwłaszcza w badaniach epidemiologicznych i przesiewowych. Zaleca się pobieranie wielu próbek w różnych odstępach czasu, a także uwzględnienie badań obrazowych (RTG, TK klatki piersiowej) oraz badań laboratoryjnych oceniających funkcję nerek i morfologię krwi.

Diagnostyka Zespołu Oddechowego Bliskiego Wschodu (MERS)

Zespół oddechowy bliskiego wschodu (MERS) to ciężka choroba układu oddechowego wywoływana przez koronawirusa MERS-CoV, po raz pierwszy zidentyfikowanego w Arabii Saudyjskiej w 2012 roku. Prawidłowa i szybka diagnostyka MERS jest kluczowa dla skutecznego zarządzania przypadkami i zapobiegania rozprzestrzenianiu się wirusa. Wczesna diagnostyka zwiększa prawdopodobieństwo uzyskania prawdziwie dodatniego wyniku testu i poprawia potencjalne wyniki zdrowotne.12

Kryteria podejrzenia MERS

MERS należy rozważyć, gdy ciężka choroba układu oddechowego pojawia się w ciągu 2 tygodni po pobycie lub podróży na Bliski Wschód lub obszary objęte wybuchem epidemii, a także po bliskim kontakcie z zakażonymi osobami. Objawy kliniczne i czynniki ryzyka epidemiologicznego są wykorzystywane w Stanach Zjednoczonych do określenia, kto powinien być testowany w kierunku MERS-CoV.12

Kluczowe czynniki diagnostyczne obejmują:

  • Pobyt lub podróż na Bliski Wschód (lub kraj, w którym występuje aktywny wybuch epidemii) w ciągu ostatnich 14 dni1
  • Wiek powyżej 14 lat1
  • Gorączka1
  • Kaszel1
  • Duszność1

Badania laboratoryjne

Diagnoza MERS wymaga specjalistycznych badań laboratoryjnych. Preferowane testy i typy próbek są kluczowe dla właściwej identyfikacji wirusa.1

Testy molekularne

Podstawowym testem diagnostycznym dla MERS jest reakcja łańcuchowa polimerazy z odwrotną transkryptazą w czasie rzeczywistym (rRT-PCR). Centers for Disease Control and Prevention (CDC) opracowało test rRT-PCR, który jest głównym testem diagnostycznym w Stanach Zjednoczonych. FDA przyznała temu testowi autoryzację do użytku w sytuacjach nadzwyczajnych.1

Diagnoza MERS wymaga pozytywnego wyniku testu molekularnego, który wskazuje na wykrycie materiału genetycznego MERS-CoV w próbce klinicznej pacjenta. Zgodnie z zaleceniami WHO, potwierdzenie przypadku wymaga wykrycia wirusowego RNA za pomocą RT-PCR, nakierowanego na region powyżej genu białka E (upE) oraz wtórnego testu PCR nakierowanego na otwartą ramkę odczytu (ORF) 1a lub 1b.12

Kryteria wykrycia RNA MERS-CoV obejmują:

  • Pozytywny wynik dla co najmniej dwóch specyficznych dla MERS-CoV genów (upE, ORF1a, ORF1b, N) metodą RT-PCR w czasie rzeczywistym (zalecane)1
  • Lub pozytywny wynik dla pojedynczego celu RT-PCR w czasie rzeczywistym plus sekwencjonowanie innego miejsca (RdRp lub gen N) w genomie MERS-CoV1

W niektórych przypadkach mogą być wymagane dodatkowe badania:

  • Sekwencjonowanie genów RdRp i fragmentów genu N może być wykorzystane do potwierdzenia1
  • W Japonii opracowano metodę RT-LAMP, która wykrywa region białka nukleokapsydu MERS-CoV w ciągu 30 minut1
Testy serologiczne

Testy serologiczne mogą być wykorzystywane do wykrywania przeciwciał u pacjentów lub kontaktów, gdy bezpośrednie wykrycie (metody molekularne) MERS-CoV jest negatywne w odpowiednich próbkach, a także do badań ludzi i zwierząt.1

Do potwierdzenia zakażenia MERS-CoV może być wymagana serokonwersja z użyciem dwóch próbek surowicy pobranych w odstępie co najmniej 14 dni. Różne testy przesiewowe są używane, takie jak pośredni test immunofluorescencji (IFA), ELISA, western blot, mikromacierze białkowe wykorzystujące cały wirus lub rekombinowane białka spike i nukleokapsydu lub rozpuszczalną podjednostkę S1 białka spike.12

Do potwierdzenia używany jest standardowy test neutralizacji (tj. test neutralizacji redukcji płytek lub test mikroneutralizacji lub przy użyciu pseudocząstek wirusa).1

Rodzaje próbek do badań

Właściwy dobór próbek jest kluczowy dla skutecznej diagnostyki MERS.

Próbki z układu oddechowego

CDC zaleca pobieranie wielu próbek z różnych miejsc w różnym czasie, gdy podejrzewa się zakażenie MERS-CoV. Preferowane są próbki z dolnych dróg oddechowych, ponieważ zawierają najwyższe miano wirusa:12

Zalecane jest pobieranie próbek zarówno z górnych, jak i dolnych dróg oddechowych. Jednak próbki z dolnych dróg oddechowych, takie jak płukanie oskrzelowo-pęcherzykowe, plwocina i aspiraty tchawiczne, zawierają najwyższe miano wirusa i są preferowane.1

Inne próbki

Jeśli pozwalają na to zasoby, należy również pobrać dodatkowe próbki:

  • Kał (MERS-CoV może być wykrywany w kale do 16 dni od początku choroby)1
  • Mocz (MERS-CoV może być wykrywany w moczu do 13 dni od początku choroby)1
  • Surowica krwi (wykrycie MERS-CoV we krwi wiązało się z gorszym wynikiem klinicznym)1

Zaleca się wielokrotne pobieranie próbek, aby zwiększyć pewność, że badana osoba nie ma aktywnego zakażenia.1

Czas pobierania próbek

Próbki z dróg oddechowych powinny być pobierane jak najszybciej po rozpoczęciu objawów, najlepiej w ciągu 7 dni. Jednak jeśli od wystąpienia objawów minął więcej niż tydzień, a pacjent wciąż ma objawy, należy nadal pobierać próbki z układu oddechowego, zwłaszcza z dolnych dróg oddechowych.1

Testowanie w kierunku MERS-CoV powinno odbywać się jak najszybciej po wystąpieniu choroby. Wcześniejsze testowanie zwiększa prawdopodobieństwo uzyskania prawdziwie dodatniego wyniku testu.1

Badania obrazowe

W ramach diagnostyki MERS wykonuje się również badania obrazowe:

U wszystkich pacjentów z MERS badania obrazowe wykazują nieprawidłowości, które mogą być subtelne lub rozległe, jednostronne lub obustronne.1

Inne badania diagnostyczne

W ramach diagnostyki MERS wykonuje się również inne badania wspomagające:

Postępowanie diagnostyczne przy podejrzeniu MERS

Algorytm diagnostyczny

CDC zaleca, aby klinicyści i departamenty zdrowia publicznego rozważyli pełną diagnozę różnicową i zlecili testy specyficzne dla patogenów w oparciu o najbardziej prawdopodobną etiologię objawów klinicznych pacjenta.1

Jeśli istnieje silne podejrzenie, że osoba objęta dochodzeniem (PUI) jest zakażona MERS-CoV, można rozważyć jednoczesne testowanie w kierunku MERS-CoV wraz z innymi możliwymi patogenami po omówieniu z państwowymi i lokalnymi departamentami zdrowia.1

Wykrycie innych patogenów układu oddechowego nie wyklucza możliwości zakażenia MERS-CoV, dlatego wszyscy pacjenci spełniający definicję przypadku powinni być testowani w kierunku MERS-CoV.1

Procedury bezpieczeństwa

Podczas przetwarzania próbek z dróg oddechowych należy nosić środki ochrony indywidualnej poziomu D i rękawice. Procedury generujące aerozole zaleca się wykonywać wewnątrz komory bezpieczeństwa biologicznego klasy II (BSC).1

Podczas pobierania i obchodzenia się z próbkami, które mogą zawierać MERS-CoV, należy przestrzegać środków ostrożności dotyczących bezpieczeństwa biologicznego. Laboratoria kliniczne i mikrobiologiczne powinny stosować standardowe praktyki laboratoryjne, w tym Standardowe Środki Ostrożności, podczas obchodzenia się z potencjalnymi próbkami MERS-CoV.1

Raportowanie przypadków

Natychmiastowe powiadomienia powinny być wysyłane do lokalnych departamentów zdrowia, jeśli istnieje podejrzenie, że pacjent jest zakażony MERS-CoV.1

W przypadku podejrzenia, że pacjent jest zakażony MERS lub zamierzenia przeprowadzenia testu na MERS, należy natychmiast skontaktować się z Oddziałem Kontroli Chorób Zakaźnych w celu uzyskania pomocy w diagnozie i wdrożeniu kontroli zakażeń.1

Laboratoria diagnostyczne

Nie wszystkie laboratoria są zatwierdzone do przeprowadzania badań MERS-CoV. Lekarz może wysłać próbki do laboratorium stanowego departamentu zdrowia lub do Centers for Disease Control and Prevention.1

W Stanach Zjednoczonych wszystkie testy diagnostyczne MERS-CoV są dostępne obecnie w CDC lub w laboratoriach zdrowia publicznego i nie są dostępne poprzez laboratoria kliniczne lub komercyjne.1

Wszystkie podejrzane próbki MERS-CoV powinny być pilnie przekazane do laboratorium referencyjnego w celu potwierdzenia, także w weekendy.1

Interpretacja wyników testów

Interpretacja negatywnego wyniku testu rRT-PCR zależy od wielu czynników, w tym rodzaju próbki i czasu od wystąpienia choroby. Pobranie i przetestowanie wielu próbek może zwiększyć pewność, że osoba objęta dochodzeniem nie ma aktywnego zakażenia.1

Jeśli wynik był negatywny w próbce z górnych dróg oddechowych, należy ponownie wykonać test z dodatkową próbką z dolnych dróg oddechowych.1

Wszystkie próbki domniemanie pozytywne w kierunku MERS-CoV powinny być przekazane do laboratorium referencyjnego w celu potwierdzenia.1

Testy szybkiej diagnostyki

Opracowano również szybkie i wizualne metody wykrywania kwasów nukleinowych, które łączą odwrotną transkrypcję z amplifikacją rekombinazą polimerazy z zamkniętym pionowym paskiem wizualizacji przepływu (RT-RPA-VF). Ten panel testowy został zaprojektowany w celu poprawy dokładności diagnostycznej poprzez podwójne badanie przesiewowe po odniesieniu do wytycznych badań laboratoryjnych dla MERS-CoV.1

RT-RPA-VF ma przewagę nad tradycyjnymi metodami PCR, ponieważ eliminuje potrzebę stosowania precyzyjnych urządzeń do cyklicznej zmiany temperatury. Dodatkowo jest prosta w implementacji i wymaga mniej czasu.1

Opracowano również metodę RT-LAMP (Loop-mediated isothermal amplification) do wykrywania MERS-CoV, która charakteryzuje się wrażliwością i specyficznością równą testom RT-PCR dla upE i ORF1a. Metoda RT-LAMP wymaga tylko jednej temperatury do amplifikacji, a wyniki są zwykle dostępne w mniej niż 1 godzinę przez obserwację wytrąconego pirofosforanu magnezu lub sygnałów fluorescencji gołym okiem.1

Szybkie testy antygenowe

Opracowano również szybki immunochromatograficzny test wykrywania antygenu MERS-CoV, który wykazuje wysoką specyficzność i czułość. Test nie wykazuje reaktywności krzyżowej z szerokim spektrum betakoronawirusów, co jest kluczowe dla wykazania, że test jest wysoce specyficzny dla MERS-CoV.1

Test ma specyficzność wynoszącą 100% i czułość 91,7% przy użyciu próbek klinicznych od wielbłądów, co jest zgodne z wynikami zgłoszonymi we wcześniejszych badaniach.1

Typ testu Zalety Wady Wskazania
RT-PCR (upE i ORF1a/ORF1b) Wysoka czułość i specyficzność, złoty standard diagnostyczny Wymaga zaawansowanego sprzętu, dłuższy czas oczekiwania na wyniki Potwierdzenie diagnozy MERS
RT-RPA-VF Szybki (< 30 min), nie wymaga zaawansowanego sprzętu Mniejsza dostępność Szybkie badania przesiewowe
RT-LAMP Szybki (< 60 min), wizualna ocena wyników Wymaga walidacji klinicznej Diagnostyka w ograniczonych warunkach
Testy serologiczne Wykrywa przebyte zakażenie Nie wykrywa wczesnego stadium zakażenia Badania epidemiologiczne, potwierdzenie przebytego zakażenia
Szybki test antygenowy Szybki, łatwy w użyciu Niższa czułość niż RT-PCR Badania przesiewowe, szczególnie u wielbłądów

Wnioski

Diagnostyka Zespołu oddechowego bliskiego wschodu (MERS) wymaga kompleksowego podejścia, obejmującego ocenę kliniczną, badania laboratoryjne i obrazowe. Kluczowymi elementami są:123

  • Dokładny wywiad epidemiologiczny uwzględniający podróże do regionów endemicznych
  • Pobieranie odpowiednich próbek, z preferencją dla materiału z dolnych dróg oddechowych
  • Zastosowanie testów molekularnych (RT-PCR) jako złotego standardu diagnostycznego
  • Potwierdzenie zakażenia przez wykrycie co najmniej dwóch różnych regionów genomowych MERS-CoV
  • Uzupełnienie diagnostyki o badania obrazowe i inne testy laboratoryjne

Szybka i dokładna diagnostyka MERS jest niezbędna dla wdrożenia odpowiednich środków kontroli zakażeń i zminimalizowania ryzyka transmisji wirusa w placówkach opieki zdrowotnej i społecznościach.12

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  1. 12.04.2026
  2. www.leksykon.com.pl

Materiały źródłowe

  • #1 Diagnostic Testing for MERS | MERS | CDC
    https://www.cdc.gov/mers/hcp/diagnosis-testing/index.html
    The criteria for diagnostic testing for MERS in the United States is also known as MERS Patient Under Investigation (PUI) criteria. […] Clinical features and epidemiologic risk factors are used in the United States to determine who should be tested for Middle East Respiratory Syndrome Coronavirus (MERS-CoV). […] All MERS diagnostic testing currently available in the United States is completed at CDC or at public health laboratories and is not available through clinical or commercial laboratories. […] All diagnostic testing for MERS in the United States is accessed through jurisdictional public health departments. Clinicians should evaluate their patients and discuss with their jurisdictional public health departments if the clinical features and epidemiologic risk factors are concerning for MERS. […] The below criteria serve as guidance for who should be tested for MERS-CoV infection in the United States. […] Testing for MERS should occur as soon as possible following onset of illness. Earlier testing increases the likelihood of identifying a true positive test result.
  • #1 Middle East respiratory syndrome (MERS) – Symptoms, diagnosis and treatment | BMJ Best Practice
    https://bestpractice.bmj.com/topics/en-gb/1301
    Middle East respiratory syndrome (MERS) should be considered when a severe respiratory illness occurs in the 2 weeks following residence in or travel to the Middle East or areas of outbreak, and/or close contact with infected individuals. […] Confirmation of infection requires specialised laboratory testing including real-time reverse transcription polymerase chain reaction (RT-PCR) on respiratory samples and serum. […] Key diagnostic factors include residence in, or travel to, the Middle East (or country where there is an active outbreak) in previous 14 days, age 14 years, fever, cough, and dyspnoea. […] 1st investigations to order include FBC, comprehensive metabolic panel, pulse oximetry, blood cultures, real-time reverse transcription polymerase chain reaction (RT-PCR), RT-PCR sequencing assay, and chest x-ray.
  • #1 Middle East respiratory syndrome coronavirus: Clinical manifestations and diagnosis – UpToDate
    https://www.uptodate.com/contents/middle-east-respiratory-syndrome-coronavirus-clinical-manifestations-and-diagnosis?search=mers%2
    Middle East respiratory syndrome coronavirus: Clinical manifestations and diagnosis […] The clinical manifestations and diagnosis of MERS-CoV are discussed here. […] DIAGNOSIS […] Preferred tests and specimen types […] Polymerase chain reaction and sequencing […] Serology […] Whom to test […] Outside the United States […] In the United States […] Specimen handling […] Where to ship specimens […] Reporting cases.
  • #1 Laboratory Testing for MERS | MERS | CDC
    https://www.cdc.gov/mers/php/laboratories/index.html
    CDC developed an rRT-PCR assay that is the primary test for MERS diagnostic purposes in the United States. FDA granted Emergency Use Authorization for this test. […] A MERS diagnosis requires a positive test result from a molecular test, which indicates that MERS-CoV genetic material was detected in a patient’s clinical specimen. […] Interpretation of a negative rRT-PCR test result depends on multiple factors, including specimen type and time since illness onset. Collecting and testing multiple specimens may increase confidence that the person under investigation does not have an active infection. […] Biosafety precautions should be taken in collecting and handling specimens that may contain MERS-CoV. […] Clinical and microbiology laboratories should follow standard laboratory practices, including Standard Precautions, when handling potential MERS-CoV specimens.
  • #1 Guidelines for the Laboratory Diagnosis of Middle East Respiratory Syndrome Coronavirus in Korea
    https://pmc.ncbi.nlm.nih.gov/articles/PMC4835438/
    Criteria for detection of MERS-CoV RNA: a positive result for at least one of the following: […] A positive result for at least two MERS-CoV-specific gene targets (upE, ORF1a, ORF1b, N) by real-time RT-PCR (recommended) […] Seroconversion using two serum specimens collected at an interval of at least 14 days […] During processing respiratory specimens, level D personal protective equipment and gloves should be worn. […] Aerosol-generating procedures are highly recommended to be performed inside a class II biosafety cabinet (BSC). […] If the result was negative in an upper respiratory tract specimen, retest with an additional lower respiratory tract specimen. […] If detection test of MERS-CoV RNA is not available, seroconversion of antibodies using acute-phase and recovery-phase serum is required to confirm MERS.
  • #1 Middle East Respiratory Syndrome Coronavirus (MERS-CoV) – Real-time PCR | Public Health Ontario
    https://www.publichealthontario.ca/en/Laboratory-Services/Test-Information-Index/Middle-Eastern-Respiratory-Syndrome-Coronavirus
    Testing for MERS-CoV requires approval by the Public Health Ontario prior to submission. […] MERS-CoV RT-PCR testing is routinely performed at PHOs laboratory, Toronto location, as needed on Monday to Friday. […] Turnaround time is up to 3 days from receipt at PHO. […] Nucleic acid is extracted from the specimen and tested by real-time PCR for the detection of MERS-CoV using protocols endorsed by the World Health Organization. […] A confirmed case should either have positive test results for at least two different sites in the virus genome tested by real-time PCR, or a positive result for a single real-time PCR target plus sequencing of a different site (RdRp or N gene) in the MERS-CoV genome. […] Serology for MERS-CoV is not currently available. […] Specimens that are positive by RT-PCR at PHO are sent to National Microbiology Laboratory (NML) in Winnipeg, MB for confirmation. […] Results are reported to the physician, authorized health care provider (General O. Reg 45/22, s.18) or submitter as indicated on the requisition.
  • #1 Azthena logo with the word Azthena
    https://www.news-medical.net/health/Middle-East-Respiratory-Syndrome-Coronavirus-(MERS-CoV)-Diagnosis.aspx
    Middle East respiratory syndrome coronavirus (MERS-CoV) is a novel coronavirus that was discovered in 2012. […] Adequate diagnosis is of the utmost importance. […] The Centers for Disease Control and Prevention (CDC) recommends taking multiple specimens from various sites at different times when MERS-CoV infection is suspected. […] Immediate notifications should be sent to the local health departments if there is a patient suspected of harboring MERS-CoV. […] The diagnosis of MERS-CoV infection is based on exposure history, clinical criteria and diagnostic findings. […] Serologic testing is also available to confirm past infection, and the diagnosis of MERS-CoV infection can be established by seroconversion in two samples taken at the acute stage and during the convalescence phase. […] At the moment, the diagnosis of MERS-CoV can be confirmed by molecular testing using the realtime reverse-transcription polymerase chain reaction (r-RT-PCR). […] Gene sequencing that targets RdRp and N gene fragments may be used for confirmation.
  • #1 IASR 36(12), 2015【Topic】Middle East Respiratory Syndrome (MERS), as of November 2015|Japan Institute for Health Security The Infectious Disease Information Website
    https://id-info.jihs.go.jp/niid/en/iasr/6147-tpc430.html
    Laboratory diagnosis of MERS-CoV (see p. 239 of this issue) For laboratory diagnosis, detection of the viral genome(s) by real-time RT-PCR is used. On account of less virus materials in the upper respiratory tract, the lower respiratory tract specimens, such as sputa, tracheal aspirate, or bronchoalveolar lavage fluid, should be used. According to the WHOs criteria, detection of at least 2 different viral genomic regions is required for confirmatory diagnosis. […] In Japan, prefectural and municipal public health institutes (PHIs), quarantine stations and the National Institute of Infectious Diseases (NIID) are prepared to conduct laboratory diagnosis. NIID has distributed the necessary diagnostic materials (e.g. upE primers, probes, positive control specimens) to PHIs and quarantine stations, and has also recently developed an RT-LAMP method that detects nucleocapsid protein region of MERS-CoV within 30 minutes.
  • #1 Factsheet about Middle East respiratory syndrome coronavirus (MERS-CoV)
    https://www.ecdc.europa.eu/en/middle-east-respiratory-syndrome-coronavirus/factsheet
    Serology can be used to detect antibodies in patients or contacts when the direct detection (molecular methods) of MERS-CoV is negative in suitable specimens, as well as for human and animal surveys. However, interpretation of MERS-CoV serological results can be hampered by the widespread circulation of other human coronaviruses such as HCoV-OC43, HCoV-HKU1, HCoV-NL63, and HCoV-229E. Different screening assays are used such as indirect immunofluorescence assay (IFA), ELISA, western blot, protein microarrays using the whole virus or recombinant spike and nucleocapsid proteins or a soluble S1 subunit of spike protein. A gold-standard neutralisation test should be used for confirmation (i.e. plaque reduction neutralisation test or micro neutralisation test or using pseudoparticle virus).
  • #1 Guidelines for the Laboratory Diagnosis of Middle East Respiratory Syndrome Coronavirus in Korea
    https://pmc.ncbi.nlm.nih.gov/articles/PMC4835438/
    The recent outbreak of Middle East respiratory syndrome (MERS) in Korea was unexpected that laboratory response had to be built up urgently during the outbreak. […] MERS TF established guidelines for laboratory diagnosis of MERS-CoV and provided it to all participating laboratories as the official guidance of MERS Joint committee. […] Cases with positive MERS-CoV on molecular tests (irrespective of the presence or absence of clinical signs and symptoms) […] a. Real time reverse transcriptase PCR (rRT-PCR): Detection of MERS-CoV RNA […] Tracheal aspirate is preferred specimens for detection test of MERS-CoV RNA. […] Before close contact cases progress to full-brown MERS an early diagnosis is essential to prevent further spread. […] For all patients with pneumonia accompanied by fever, the detection tests of MERS-CoV RNA is incorporated to the diagnostic panels to differentiate the cause of SARI during MERS epidemics.
  • #1 Factsheet about Middle East respiratory syndrome coronavirus (MERS-CoV)
    https://www.ecdc.europa.eu/en/middle-east-respiratory-syndrome-coronavirus/factsheet
    WHO provides recommendations for laboratory testing for MERS-CoV. These are based on, and updated according to, the latest scientific knowledge. The most recent recommendations can be found on the WHO Global Alert and Response webpage for coronavirus. […] Both upper and lower respiratory tract specimens should be collected. Lower respiratory tract specimens, such as bronchoalveolar lavage, sputum and tracheal aspirates contain the highest viral loads and are to be preferred. If resources permit, further samples from faeces and urine should also be collected and repeated sampling is highly recommended to gather further evidence on viral shedding and infectious periods. […] Currently, confirmation of cases according to WHO standards is performed with detection of viral RNA by real-time PCR targeting upstream of the MRS-CoV E protein (upE) and then a secondary PCR assay targeting open reading frame (ORF) 1a or 1b. A negative secondary PCR result would require further nucleotide sequencing of the viral RNA.
  • #1
    https://www.gov.uk/government/publications/middle-east-respiratory-syndrome-coronavirus-mers-cov-testing/testing-for-the-middle-east-respiratory-syndrome-coronavirus-mers-cov-in-england
    This guidance describes the process for primary and confirmatory testing of human samples for MERS-CoV testing when MERS-CoV is being considered as a diagnosis. […] MERS diagnostic testing should be requested as soon as possible. Samples should be obtained and sent to a primary MERS testing laboratory within 12 hours of case suspicion. […] All presumptive positive MERS-CoV samples must be sent to RVU for confirmatory testing, regardless of where the primary testing was performed. […] Testing should not be delayed; samples should be obtained and sent to a MERS testing laboratory within 12 hours of suspicion. […] The recommended minimum diagnostic sample set for MERS-CoV testing is: an upper respiratory tract sample (a combined nose and throat viral swab, or nasopharyngeal aspirate) and a lower respiratory tract sample (such as sputum, endotracheal tube aspirate or BAL if intubated), if obtainable.
  • #1 Middle East respiratory syndrome coronavirus (MERS-CoV): what lessons can we learn?
    https://pmc.ncbi.nlm.nih.gov/articles/PMC7114843/
    Diagnosis is confirmed by detection of MERS-CoV RNA in respiratory samples by real-time PCR targeting the upE and ORF 1b genes. Samples obtained from the lower respiratory tract have higher viral loads and better diagnostic yield than those obtained from the throat or nasopharynx. […] Moreover, viral shedding is considerably prolonged in symptomatic and severely ill MERS-CoV patients compared with asymptomatic infected contacts. […] Interestingly, detection of MERS-CoV in blood has been associated with worse clinical outcome. […] MERS-CoV may also be detected in stool for up 16 days and in urine for up to 13 days from disease onset. […] In the absence of appropriate precautions, the environment surrounding a symptomatic MERS-CoV patient can therefore become extensively contaminated with viable, potentially infectious virus.
  • #1 Middle Eastern Respiratory Syndrome (MERS) | Disease Outbreak Control Division
    https://health.hawaii.gov/docd/disease_listing/middle-eastern-respiratory-syndrome-mers/
    Molecular tests are used to diagnose people who are thought to be infected with MERS based on their clinical symptoms and having links to places where MERS has been reported (Saudia Arabia, Jordan, Qatar, or the United Arab Emirates). […] It is recommended that 3 specimens be collected for testing using molecular diagnostics (Real-time reverse transcription PCR); lower respiratory, upper respiratory and serum specimens. […] Respiratory specimens should be collected as soon as possible after symptoms begin ideally within 7 days. […] However, if more than a week has passed since symptom onset and the patient is still symptomatic, respiratory samples should still be collected; especially lower respiratory specimens.
  • #1 Content – Health Encyclopedia – University of Rochester Medical Center
    https://www.urmc.rochester.edu/encyclopedia/content?contenttypeid=134&contentid=252
    How is MERS diagnosed? The healthcare providers will ask about your health history. They will also ask about when you were exposed to MERS. They may ask about your recent travel and contact with sick people. They may also ask about recent contact with camels. […] You will have tests to check for the cause of your symptoms. The symptoms of MERS can also be caused by other illnesses. You may have tests, such as: […] Chest X-ray. X-rays use a small amount of radiation to make images of the inside of your body. A chest X-ray is done to check for problems in your lungs. […] Blood tests. Blood is taken from a vein in your arm or hand. This is done to check for certain chemicals that can show if you have the MERS virus or other illness. […] Nasal or throat swab. A stick with a small piece of cotton at the tip is wiped inside your nose or throat. This is done to check for viruses in your nasal mucus. […] Stool culture. A small sample of stool is collected from your rectum or from a bowel movement. The sample is checked for the virus. […] Sputum culture. A small sample of mucus coughed from your lungs is collected. It is checked for the virus.
  • #1 Middle East respiratory syndrome (MERS) – Symptoms, diagnosis and treatment | BMJ Best Practice US
    https://bestpractice.bmj.com/topics/en-us/1301
    Middle East respiratory syndrome (MERS) should be considered when a severe respiratory illness occurs in the 2 weeks following residence in or travel to the Middle East or areas of outbreak, and/or close contact with infected individuals. […] Confirmation of infection requires specialized laboratory testing including real-time reverse transcription polymerase chain reaction (RT-PCR) on respiratory samples and serum. […] Key diagnostic factors include residence in, or travel to, the Middle East (or country where there is an active outbreak) in previous 14 days, age 14 years, fever, cough, and dyspnea. […] 1st tests to order include CBC, comprehensive metabolic panel, pulse oximetry, blood cultures, real-time reverse transcription polymerase chain reaction (RT-PCR), RT-PCR sequencing assay, and chest x-ray. […] Tests to consider include serology and CT chest.
  • #1 Coronaviruses and Acute Respiratory Syndromes (MERS and SARS) – Infectious Diseases – Merck Manual Professional Edition
    https://www.merckmanuals.com/professional/infectious-diseases/respiratory-viruses/coronaviruses-and-acute-respiratory-syndromes-mers-and-sars
    Middle East respiratory syndrome (MERS) is a severe, acute respiratory illness caused by the MERS coronavirus (MERS-CoV). […] MERS should be suspected in patients who have an unexplained acute febrile lower respiratory infection and who have had any of the following within 14 days of symptom onset: […] Testing should include real-time RT-PCR testing of upper and lower respiratory secretions, ideally taken from different sites and at different times. […] In all patients, chest imaging detects abnormalities, which may be subtle or extensive, unilateral or bilateral. […] Diagnosis of MERS is made clinically, and treatment is supportive.
  • #1 Middle Eastern Respiratory Syndrome (MERS) | American Lung Association
    https://www.lung.org/lung-health-diseases/lung-disease-lookup/middle-eastern-respiratory-syndrome-mers
    Symptoms of respiratory illness and recent travel to the Middle East region should raise the suspicion that a patient may have MERS. If your doctor suspects MERS, you will have a chest X-ray, blood tests, kidney function tests and respiratory samples (lung secretions) for evaluation. […] Early diagnosis improves potential health outcomes. You should see a doctor promptly if you have traveled to affected areas, particularly the Middle East, or had contact with people known to be infected with the MERS virus and are exhibiting the above symptoms.
  • #1 Laboratory Testing for MERS | MERS | CDC
    https://www.cdc.gov/mers/php/laboratories/index.html
    CDC works with state and local public health departments, clinicians, travel industry partners, and others to identify and test people who may be infected with Middle East respiratory syndrome coronavirus (MERS-CoV). […] CDC recommends that clinicians and public health departments consider a full differential diagnosis, and order pathogen-specific testing based on the most likely etiology for the patient’s clinical presentation. […] If there is strong suspicion that a person under investigation (PUI) is infected with MERS-CoV, simultaneous testing for MERS-CoV along with other possible pathogens can be considered following discussion with state and local health departments. […] Multiple public health laboratories offer diagnostic MERS-CoV PCR testing, which is a type of nucleic acid amplification test (NAAT).
  • #1
    https://www.gov.uk/government/publications/middle-east-respiratory-syndrome-coronavirus-mers-cov-testing/testing-for-the-middle-east-respiratory-syndrome-coronavirus-mers-cov-in-england
    All presumptive MERS positive samples from these laboratories should be urgently forwarded to the Colindale UKHSA laboratory for confirmation. […] Detection of other respiratory pathogens does not rule out the possibility of MERS-CoV infection, therefore all cases meeting the case definition should be tested for MERS-CoV. […] Presumptive positive MERS-CoV samples should be forwarded urgently to RVU for confirmatory testing, including at weekends. […] RVU will report all results of confirmatory testing, positive and negative by telephone to the laboratory that produced the presumptive positive result. […] Once a presumptive positive MERS-CoV result has been confirmed by testing at RVU, follow-up samples will need to be tested for MERS-CoV.
  • #1 Department of Public Health – Acute Communicable Disease Control
    http://publichealth.lacounty.gov/acd/mers.htm
    If you suspect that a patient is infected with MERS or intend to test a patient for MERS, immediately call Acute Communicable Disease Control to assist with diagnosis and implementation of infection control. […] MERS in the United States […] Information for Healthcare Professionals […] MERS Case Definitions […] Information for Laboratories.
  • #1 Middle East Respiratory Syndrome: Symptoms & Treatment
    https://my.clevelandclinic.org/health/diseases/22633-middle-east-respiratory-syndrome-mers
    Middle East respiratory syndrome (MERS) is a severe respiratory illness caused by a type of coronavirus. It was first reported in Saudi Arabia in 2012. […] Laboratory tests can determine if you have active MERS or a previous MERS infection. Your provider may collect several samples for laboratory testing, including: […] Not all laboratories are approved to do MERS-CoV testing. Your provider may send the samples to your state health department laboratory or to the Centers for Disease Control and Prevention. […] Currently, there is no approved treatment for MERS. Your medical care will focus on managing your symptoms while your body fights the infection. […] If you know or think you may have MERS, take steps to prevent infecting others: […] You should call your provider if you have symptoms of MERS and think you were exposed to MERS-CoV. Exposure may include direct contact with someone with MERS or if you or a close contact recently traveled to the Arabian Peninsula.
  • #1 Nucleic acid visualization assay for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) by targeting the UpE and N gene | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0009227
    Nucleic acid visualization assay for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) by targeting the UpE and N gene […] Since its first emergence in 2012, cases of infection with Middle East respiratory syndrome coronavirus (MERS-CoV) have continued to occur. […] The emergence of MERS-CoV has highlighted need for a rapid and accurate assay to triage patients with a suspected infection in a timely manner because of the lack of an approved vaccine or an effective treatment for MERS-CoV to prevent and control potential outbreaks. In this study, we present two rapid and visual nucleic acid assays that target the MERS-CoV UpE and N genes as a panel that combines reverse transcription recombinase polymerase amplification with a closed vertical flow visualization strip (RT-RPA-VF). This test panel was designed to improve the diagnostic accuracy through dual-target screening after referencing laboratory testing guidance for MERS-CoV. The limit of detection was 1.2101 copies/l viral RNA for the UpE assay and 1.2 copies/l viral RNA for the N assay, with almost consistent with the sensitivity of the RT-qPCR assays. […] The two assays exhibited no cross-reactivity with multiple CoVs, including the bat severe acute respiratory syndrome related coronavirus (SARSr-CoV), the bat coronavirus HKU4, and the human coronaviruses 229E, OC43, HKU1 and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Furthermore, the panel does not require sophisticated equipment and provides rapid detection within 30 min. This panel displays good sensitivity and specificity and may be useful to rapidly detect MERS-CoV early during an outbreak and for disease surveillance.
  • #1 Nucleic acid visualization assay for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) by targeting the UpE and N gene | PLOS Neglected Tropical Diseases
    https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0009227
    The diagnostic method for MERS-CoV is mainly nucleic acid detection. The World Health Organization (WHO) recommends real-time RT-PCR targeting the sequence upstream of the envelope protein gene (UpE) and the open reading frame 1ab (ORF1ab) or the gene encoding the nucleocapsid protein gene (N) as the screening and diagnostic targets for MERS-CoV. […] Real-time RT-PCR has great advantages in terms of high sensitivity and technological maturity; however, the need for sophisticated instruments has led to the delivery of specimens from low-resource settings to highly equipped centralized laboratories for testing. This approach results in a significant delay in the reporting of test results, which delays epidemic outbreak control and treatment. […] In this study, we present two nucleic acid visualization assays targeting the MERS-CoV UpE and N genes, which are rapid and highly sensitive methods to amplify MERS-CoV RNA by reverse transcription RPA (RT-RPA). […] Compared with PCR technology, the RT-RPA-VF assay has eliminated the need for precision temperature cycling instruments. Additionally, it has the advantages of being simple to implement and requires less time. Based on these properties, the RT-RPA-VF assay has been used as an alternative to the RT-PCR or RT-qPCR to detect various pathogens. In particular, the rapid and accurate RT-RPA-VF assay has potential to reduce the risk of contagion in the early stages of an epidemic.
  • #1 Detection of Middle East respiratory syndrome coronavirus using reverse transcription loop-mediated isothermal amplification (RT-LAMP) | Virology Journal | Full Text
    https://virologyj.biomedcentral.com/articles/10.1186/1743-422X-11-139
    These results suggest that the RT-LAMP assay described here is a useful tool for the diagnosis and epidemiologic surveillance of human MERS-CoV infections. […] This study describes a novel genetic diagnostic method for MERS-CoV based on the RT-LAMP assay, with a sensitivity and specificity equal to that of the upE and ORF1a RT-PCR assays. […] The RT-LAMP method requires only a single temperature for amplification, with results usually available in less than 1 h by observing magnesium pyrophosphate precipitate or fluorescence signals by the naked eye. […] Taken together, the specificity and sensitivity of the RT-LAMP assay described here, in combination with its accessibility and ease of use, make this assay a valuable tool for the diagnosis and epidemiologic surveillance of human MERS-CoV infection, especially for field use.
  • #1
    https://journals.lww.com/imd/fulltext/2022/12000/evaluation_of_a_rapid_immunochromatographic_middle.7.aspx
    Here, we report the results of further evaluation for the assay using a broader spectrum of important CoVs that were not included in their study, as well as MERS-CoV real-time quantitative RT-PCR positive and RT-PCR negative nasal samples collected from dromedaries in Dubai, UAE. […] In this study, we showed that the rapid immunochromatographic MERS-CoV antigen detection assay has a high specificity and sensitivity. For the specificity, a wide spectrum of betacoronaviruses was tested for possible cross-reactivity, but none of them showed false-positive results. […] The lack of cross-reactivity between Ty-BatCoV HKU4 and MERS-CoV for the rapid antigen detection assay is crucial for showing that the assay is highly specific for MERS-CoV. […] In addition to these CoVs, the assay also showed 100% specificity and 91.7% sensitivity using clinical samples from dromedaries, concurring with the results reported by Song et al.
  • #2 Middle Eastern Respiratory Syndrome (MERS) | American Lung Association
    https://www.lung.org/lung-health-diseases/lung-disease-lookup/middle-eastern-respiratory-syndrome-mers
    Symptoms of respiratory illness and recent travel to the Middle East region should raise the suspicion that a patient may have MERS. If your doctor suspects MERS, you will have a chest X-ray, blood tests, kidney function tests and respiratory samples (lung secretions) for evaluation. […] Early diagnosis improves potential health outcomes. You should see a doctor promptly if you have traveled to affected areas, particularly the Middle East, or had contact with people known to be infected with the MERS virus and are exhibiting the above symptoms.
  • #2 Diagnostic Testing for MERS | MERS | CDC
    https://www.cdc.gov/mers/hcp/diagnosis-testing/index.html
    The criteria for diagnostic testing for MERS in the United States is also known as MERS Patient Under Investigation (PUI) criteria. […] Clinical features and epidemiologic risk factors are used in the United States to determine who should be tested for Middle East Respiratory Syndrome Coronavirus (MERS-CoV). […] All MERS diagnostic testing currently available in the United States is completed at CDC or at public health laboratories and is not available through clinical or commercial laboratories. […] All diagnostic testing for MERS in the United States is accessed through jurisdictional public health departments. Clinicians should evaluate their patients and discuss with their jurisdictional public health departments if the clinical features and epidemiologic risk factors are concerning for MERS. […] The below criteria serve as guidance for who should be tested for MERS-CoV infection in the United States. […] Testing for MERS should occur as soon as possible following onset of illness. Earlier testing increases the likelihood of identifying a true positive test result.
  • #2 Factsheet about Middle East respiratory syndrome coronavirus (MERS-CoV)
    https://www.ecdc.europa.eu/en/middle-east-respiratory-syndrome-coronavirus/factsheet
    WHO provides recommendations for laboratory testing for MERS-CoV. These are based on, and updated according to, the latest scientific knowledge. The most recent recommendations can be found on the WHO Global Alert and Response webpage for coronavirus. […] Both upper and lower respiratory tract specimens should be collected. Lower respiratory tract specimens, such as bronchoalveolar lavage, sputum and tracheal aspirates contain the highest viral loads and are to be preferred. If resources permit, further samples from faeces and urine should also be collected and repeated sampling is highly recommended to gather further evidence on viral shedding and infectious periods. […] Currently, confirmation of cases according to WHO standards is performed with detection of viral RNA by real-time PCR targeting upstream of the MRS-CoV E protein (upE) and then a secondary PCR assay targeting open reading frame (ORF) 1a or 1b. A negative secondary PCR result would require further nucleotide sequencing of the viral RNA.
  • #2 Factsheet about Middle East respiratory syndrome coronavirus (MERS-CoV)
    https://www.ecdc.europa.eu/en/middle-east-respiratory-syndrome-coronavirus/factsheet
    Serology can be used to detect antibodies in patients or contacts when the direct detection (molecular methods) of MERS-CoV is negative in suitable specimens, as well as for human and animal surveys. However, interpretation of MERS-CoV serological results can be hampered by the widespread circulation of other human coronaviruses such as HCoV-OC43, HCoV-HKU1, HCoV-NL63, and HCoV-229E. Different screening assays are used such as indirect immunofluorescence assay (IFA), ELISA, western blot, protein microarrays using the whole virus or recombinant spike and nucleocapsid proteins or a soluble S1 subunit of spike protein. A gold-standard neutralisation test should be used for confirmation (i.e. plaque reduction neutralisation test or micro neutralisation test or using pseudoparticle virus).
  • #2 MERS – Wikipedia
    https://en.wikipedia.org/wiki/MERS
    For PCR testing, the World Health Organization (WHO) recommends obtaining samples from the lower respiratory tract via bronchoalveolar lavage (BAL), sputum sample or tracheal aspirate as these have the highest viral loads. […] Several highly sensitive, confirmatory real-time RT-PCR assays exist for rapid identification of MERS-CoV from patient-derived samples.
  • #2
    https://link.springer.com/article/10.1007/s11547-020-01311-x
    MERS and SARS have been associated with acute kidney injury (AKI), possibly caused by virus tropism for the kidneys and secondary damage due to systemic inflammation and hypotension. […] MERS-CoV infection usually causes severe extra-pulmonary organ dysfunction, and most patients present with shock, acute kidney injury, and thrombocytopenia. […] According to this study, older patients had higher incidence of AKI. […] In a retrospective study with 30 patients diagnosed with MERS, eight (26.7%) patients developed AKI, and 15 (50%) showed proteinuria. […] Studies have reported a variety of liver abnormalities caused by SARS and MERS, including mild to moderately elevated transaminases, hypoalbuminemia, mild steatosis, congestion, and necrosis. […] MERS causes mild inflammation in the liver. Still, the mechanism of entering the cell is different through other types of cell receptors (DDP-4), which also has high expressivity in hepatocytes.
  • #2
    https://www.who.int/news-room/fact-sheets/detail/middle-east-respiratory-syndrome-coronavirus-(mers-cov)
    Transmission of MERS-CoV has occurred in health care facilities in several Member States, including from patients to health care workers and between patients in a health care setting before MERS-CoV was diagnosed. […] However, it is not always possible to identify patients with MERSCoV early or without testing because symptoms and other clinical features may be nonspecific. […] Infection prevention and control measures are therefore critical to prevent the possible spread of MERSCoV in health care facilities.
  • #3 Middle East respiratory syndrome (MERS) – Symptoms, diagnosis and treatment | BMJ Best Practice
    https://bestpractice.bmj.com/topics/en-gb/1301
    Middle East respiratory syndrome (MERS) should be considered when a severe respiratory illness occurs in the 2 weeks following residence in or travel to the Middle East or areas of outbreak, and/or close contact with infected individuals. […] Confirmation of infection requires specialised laboratory testing including real-time reverse transcription polymerase chain reaction (RT-PCR) on respiratory samples and serum. […] Key diagnostic factors include residence in, or travel to, the Middle East (or country where there is an active outbreak) in previous 14 days, age 14 years, fever, cough, and dyspnoea. […] 1st investigations to order include FBC, comprehensive metabolic panel, pulse oximetry, blood cultures, real-time reverse transcription polymerase chain reaction (RT-PCR), RT-PCR sequencing assay, and chest x-ray.