Materiały źródłowe

• #1 Tuberculosis | Pioneering Diagnostics

  https://www.biomerieux.com/corp/en/our-offer/hospital-laboratory/patient-condition/tuberculosis.html

  Tuberculosis remains a major global public health problem and one of the leading causes of death worldwide, with nearly 4,000 lives lost every day. Over 10 million new cases are recorded each year. […] With prompt diagnosis and appropriate antibiotic treatment, most people with TB can be cured. However, diagnosis of TB is often delayed, due to multiple factors including a lack of knowledge or awareness of TB, non-specific symptoms, and inadequate access to healthcare. Additionally, diagnosing active TB and latent TB involve different approaches. […] Methods for diagnosing active TB include bacteriological confirmation and clinical diagnosis. Bacteriological confirmation, including traditional microbial culture, lateral flow urine lipoarabinomannan (LF-LAM) assays, sputum smear microscopy, or rapid molecular tests, is a necessary step for identifying TB that is resistant to antimicrobials.

• #2 Tuberculosis: Causes, Symptoms, Treatment & Prevention

  https://my.clevelandclinic.org/health/diseases/11301-tuberculosis

  Healthcare providers use a skin or blood test to diagnose TB. You might also need: […] Healthcare providers treat both active and inactive tuberculosis with specific kinds of antibiotics. You’ll likely need to take a combination of medications to get rid of the infection. […] If you’ve been exposed to TB, you should talk to your healthcare provider right away. They can talk to you about options for getting tested. It’s important to get tested if you’ve developed any symptoms you could pass TB on to others. […] You can reduce your risk of contracting and spreading TB by: […] TB is responsible for many deaths around the world. But it’s treatable if you take medications as your healthcare provider directs. Make sure you contact your healthcare provider if you think you’ve been exposed to, or have symptoms of, TB.

• #3 Tuberculosis Symptoms and Diagnosis | American Lung Association

  https://www.lung.org/lung-health-diseases/lung-disease-lookup/tuberculosis/symptoms-diagnosis

  A person who suspects that they may have been exposed to TB should contact their health care provider or health department as soon as possible. […] A health care provider will start by collecting a patient history to determine if an individual may have been exposed to TB. During a physical exam, they will use a stethoscope to listen to the lungs and check the lymph nodes in the neck for swelling. […] There are two types of tests for TB infection: […] A positive test result for TB infection means there is TB germs in the body. A health care provider will do other tests to determine if it is inactive TB or active TB disease. These tests may include a chest x-ray and a test of the sputum (coughed-up mucus) for bacteria. […] A negative test result for TB infection means inactive TB or active TB disease is unlikely, but a health care provider may do additional tests especially if: An individual has symptoms of active TB disease, such as coughing, chest pain, fever, weight loss, or fatigue.

• #4 Transforming tuberculosis diagnosis | Nature Microbiology

  https://www.nature.com/articles/s41564-023-01365-3

  Diagnosis is the weakest aspect of tuberculosis (TB) care and control. […] But globally, diagnosis is the weakest link in the TB cascade or continuum of care, with only one in two people with drug-sensitive TB completing all the steps of the care cascade. […] In 2021, of the estimated 10.6 million people who developed TB, only 6.4 million people were diagnosed and notified to national TB programmes worldwide. […] Simply put, if we cannot find TB, we cannot treat TB. And if we cannot treat TB, we cannot end TB. […] It is crucial to phase out sputum smear microscopy and replace it with WHO-approved molecular diagnostics as the initial diagnostic. This would not only increase the sensitivity of TB diagnosis, but also widen access to drug-resistance testing, and reduce the risk of amplifying drug-resistant TB strains.

• #4 Transforming tuberculosis diagnosis | Nature Microbiology

  https://www.nature.com/articles/s41564-023-01365-3

  The COVID-19 pandemic resulted in substantial innovations in miniaturized, simplified, low maintenance molecular platforms that can be decentralized and used in primary health clinics or homes, for example, single-use, disposable, molecular self-tests for SARS-CoV-2 and influenza. […] Multi-disease testing offers a solution to this problem. […] Non-sputum-based tests could also help to detect subclinical disease, which is defined as microbiologically confirmed disease in individuals not reporting symptoms. […] The massive gap in TB detection, made worse during the pandemic, has already cost lives, worsened transmission, and derailed years of progress in TB care and control. The seven transitions we describe could be truly transformative. They could close the diagnostic gap, and diagnose more people thereby enabling TB treatment, which would in turn reduce spread of TB in the community.

• #5 Clinical and Laboratory Diagnosis for Tuberculosis | Tuberculosis (TB) | CDC

  https://www.cdc.gov/tb/hcp/testing-diagnosis/clinical-and-laboratory-diagnosis.html

  A complete medical evaluation for TB disease has five components: Medical history, Physical examination, TB blood tests or TB skin test, Chest radiograph, Bacteriologic examination. […] Health care providers should „Think TB” for people with respiratory symptoms, especially if they have risk factors for TB. […] A positive TB blood test result or TB skin test result usually means TB infection. More tests, such as a chest radiograph, are needed to rule out TB disease. […] Chest radiographs (x-rays) help differentiate between latent TB infection and pulmonary TB disease in people with positive results from a TB blood test or TB skin test. […] Treatment generally should not be delayed while waiting for bacteriologic results if TB disease is the presumptive diagnosis. […] Drug susceptibility tests should be done when a patient is first found to have a positive culture for M. tuberculosis. […] TB is a nationally notifiable disease, and reporting is mandated in all states. […] All persons with clinically active or presumed TB disease should be reported promptly to the local or state health department.

• #5 Clinical and Laboratory Diagnosis for Tuberculosis | Tuberculosis (TB) | CDC

  https://www.cdc.gov/tb/hcp/testing-diagnosis/clinical-and-laboratory-diagnosis.html

  All persons with signs or symptoms of TB disease, or a positive result from a TB blood test or skin test should be medically evaluated for TB disease. […] Latent TB infection is diagnosed if the person has a positive result from a TB blood test or skin test and a medical evaluation does not indicate TB disease. […] TB disease is diagnosed by medical history, physical examination, chest x-ray, and other laboratory tests, including culture. […] Diagnosing and treating people with latent TB infection prevents the development of TB disease. […] TB disease was the leading cause of death for many groups and regions in the United States at the beginning of the 20th century, but is not as common in the United States now. […] Most people with TB disease have one or more symptoms that lead them to seek medical care, but occasionally, TB disease is discovered during a medical examination for an unrelated condition.

• #6 Tuberculosis (TB) Workup: Approach Considerations, Sputum Smear, Nucleic Acid Amplification Tests

  https://emedicine.medscape.com/article/230802-workup

  The primary screening method for tuberculosis (TB) infection (active or latent) is the Mantoux tuberculin skin test with purified protein derivative (PPD). An in vitro blood test based on interferon-gamma release assay (IGRA) with antigens specific for Mycobacterium tuberculosis can also screen for latent TB infection. IGRA assays offer certain advantages over tuberculin skin testing. […] Obtain the following laboratory tests for patients with suspected TB: Acid-fast bacilli (AFB) smear and culture – Using sputum obtained from the patient. HIV serology in all patients with TB and unknown HIV status. […] AFB stain is quick but requires a very high organism load for positivity and the expertise to read the stained sample. This test is more useful in patients with pulmonary disease. Other diagnostic testing may need to be considered, as a delay in diagnosis can increase patient mortality. Traditional mycobacterial cultures require weeks for growth and identification. Newer technologies allow identification within 24 hours.

• #6 Tuberculosis (TB) Workup: Approach Considerations, Sputum Smear, Nucleic Acid Amplification Tests

  https://emedicine.medscape.com/article/230802-workup

  Obtain a chest radiograph to evaluate for possible associated pulmonary findings. If chest radiography findings suggest TB and a sputum smear is positive for AFB, initiate treatment for TB. […] Symptoms and radiographic findings do not differentiate multidrug-resistant TB (MDR-TB) from fully susceptible TB. Suspect MDR-TB if the patient has a history of previous treatment for TB, was born in or lived in a country with a high prevalence of MDR-TB, has a known exposure to an MDR-TB case, or is clinically progressing despite standard TB therapy. […] Extrapulmonary involvement occurs in one fifth of all TB cases, although 60% of patients with extrapulmonary manifestations of TB have no evidence of pulmonary infection on chest radiograph or sputum culture. […] The hallmark of extrapulmonary TB histopathology is the caseating granuloma, consisting of giant cells with central caseating necrosis. Rarely, if ever, are any TB bacilli seen.

• #6 Tuberculosis (TB) Workup: Approach Considerations, Sputum Smear, Nucleic Acid Amplification Tests

  https://emedicine.medscape.com/article/230802-workup

  Culture for AFB is the most specific test for TB and allows direct identification and determination of the causative organism’s susceptibility. […] Positive cultures should be followed by drug susceptibility testing. […] An automated molecular test that uses sputum samples for detecting M tuberculosis and resistance to rifampin has been developed. […] The primary screening method for TB infection (active or latent) is the Mantoux tuberculin skin test with PPD. Tuberculin sensitivity develops 2-10 weeks after infection and usually is lifelong. […] An in vitro blood test based on IGRA with antigens specific for M tuberculosis can also be used to screen for latent TB infection and offers certain advantages over tuberculin skin testing.

• #6 Tuberculosis (TB) Workup: Approach Considerations, Sputum Smear, Nucleic Acid Amplification Tests

  https://emedicine.medscape.com/article/230802-workup

  The best diagnostic tests for congenital TB are the pathologic and histologic examination of the placenta and a placental culture. Mycobacterial blood cultures of the newborn also may be helpful. […] Individuals infected with HIV are at increased risk for TB, beginning within the first year of HIV infection. All patients who are diagnosed with active TB and who are not known to be HIV positive should be considered for HIV testing. […] Patients suspected of having TB should submit sputum for AFB smear and culture. Sputum should be collected in the early morning on 3 consecutive days. […] The absence of a positive smear result does not exclude active TB infection. Approximately 35% of culture-positive specimens are associated with a negative smear result. […] Deoxyribonucleic acid (DNA) probes specific for mycobacterial ribosomal RNA identify species of clinically significant isolates after recovery.

• #7 Advancing Tuberculosis Diagnosis and Treatment – Center for Health Decision Science

  https://chds.hsph.harvard.edu/advancing-tuberculosis-diagnosis-and-treatment/

  CHDS Nicolas Menzies recently participated in a panel discussion on Advances in Genomic Surveillance and Tuberculosis Diagnosis, hosted by Harvard T.H. Chan School of Public Health. […] The discussion highlighted the growing recognition of asymptomatic TB patients and their role in spreading the disease. Experts stressed the need for better diagnostic tools and treatment methods to tackle the global TB crisis. […] Menzies pointed out that genomic surveillance is a key strategy for detecting and monitoring hard-to-diagnose TB cases. […] Panelists also noted the need for more research and resources to address the complexities of TB transmission, especially in asymptomatic carriers. […] Menzies and others stressed the importance of partnerships between governments, researchers, and activists to ensure new treatments reach those in need.

• #8 TB Test: What It Is, How It Works, Results & Side Effects

  https://my.clevelandclinic.org/health/diagnostics/22751-tuberculosis-tb-test

  A TB test checks to see if youve been infected with tuberculosis (TB). There are two types of TB tests: a skin test and a blood test. TB skin and blood tests can show if youve ever been exposed to the bacterium that causes TB, but they cant determine if you have a latent (dormant) or active TB infection. […] A TB test checks to see if youve been infected with Mycobacterium tuberculosis complex, which is the bacteria that causes tuberculosis (TB). There are two types of latent tuberculosis infection (LTBI) screen tests: a skin test and a blood test. […] A TB skin test is also called a Mantoux test or tuberculin skin test (TST). A TB blood test is also called an Interferon-Gamma Release Assay (IGRA). TB skin tests are more common and are the preferred type for children under age 5. But blood tests for TB are becoming more common, especially for healthcare workers and those who have compromised immune systems or are going to become immunocompromised by medications.

• #8 TB Test: What It Is, How It Works, Results & Side Effects

  https://my.clevelandclinic.org/health/diagnostics/22751-tuberculosis-tb-test

  TB skin and blood tests can show if youve ever been infected with M. tuberculosis complex, but they cant distinguish between a latent (dormant) or active TB infection. Youll need additional tests (like a sputum test) to see if you have an active infection. […] You may need a TB test if you have symptoms of an active TB infection or if youre at a higher risk for getting TB. […] The results of a TB skin test or blood test will be either negative or positive. Its important to remember that these tests only show if youve been exposed to the tuberculosis infection not if your infection is active or latent. […] If your TB skin test or blood test is positive, it probably means youve been exposed to the bacterium that causes TB. Your healthcare provider will likely order more tests to help make a diagnosis. Tests that diagnose active TB infections include chest X-rays and laboratory tests on a sputum sample.

• #9 Tuberculosis – Diagnosis & treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/tuberculosis/diagnosis-treatment/drc-20351256

  To diagnosis a tuberculosis (TB) infection, your healthcare professional will do an exam that includes: […] Your healthcare professional will order tests if: […] Your healthcare team will determine whether a skin test or blood test is the best option. […] A tiny amount of a substance called tuberculin is injected just below the skin on the inside of one forearm. […] A positive test indicates you likely have either a latent TB infection or active TB disease. […] A negative test means that your body didn’t react to the test. It doesn’t necessarily mean you don’t have an infection. […] A sample of blood is sent to a lab. […] A positive test shows that you have either a latent TB infection or active TB disease. […] A negative result means you likely do not have a TB infection. […] A chest X-ray can show irregular patches in the lungs that are typical of active TB disease.

• #10 Tuberculosis (TB) Blood Test (IGRA) – MN Dept. of Health

  https://www.health.state.mn.us/diseases/tb/basics/factsheets/igra.html

  The tuberculosis (TB) blood test, also called an Interferon Gamma Release Assay or IGRA, is a way to find out if you have TB germs in your body. The TB blood test can be done instead of a TB skin test (Mantoux). […] There are two kinds of TB blood tests: QuantiFERON-TB and T-SPOT.TB. […] A negative TB blood test result usually means that you dont have TB germs in your body. […] A positive TB blood test result means you probably have TB germs in your body. Most people with a positive TB blood test have latent TB infection. To be sure, your doctor will examine you and do a chest x-ray. You may need other tests to see if you have latent TB infection or active TB disease. […] If you had the BCG vaccine and you have a choice of having a TB blood test or a TB skin test, it is better for you to have the TB blood test. This is because the TB blood test is not affected by the BCG vaccine. This means that your TB blood test will be positive only if you have TB germs in your body.

• #11 Testing for Diagnosis of Active or Latent Tuberculosis AHS – G2063 | Providers | Blue Cross NC

  https://www.bluecrossnc.com/providers/policies-guidelines-codes/commercial/laboratory/updates/testing-for-diagnosis-of-active-or-latent-tuberculosis

  Mycobacterial infection results in a predominantly cell-mediated immune response (Daniel, 1980). […] Interferon-gamma release assays (IGRAs), which are in-vitro culture assays measuring IFN-γ production in response to tuberculin antigen stimulation, have been developed as diagnostic screening tests (Katial et al., 2001; Lein & Von Reyn, 1997) IGRAs have specificity >95% for diagnosis of latent TB infection and a sensitivity of 80-90% (Menzies et al., 2007; Pai et al., 2014). […] The diagnosis of TB disease should be suspected in patients with relevant clinical manifestations and exposure history (Lewinsohn et al., 2017). Laboratory testing is an integral part of the rapid and accurate diagnosis of TB to facilitate timely initiation of treatment. […] Microbiologic testing is used to evaluate an active TB infection. These tests may include the acid-fast bacilli smear (AFB), the mycobacterial culture, and molecular testing.

• #11 Testing for Diagnosis of Active or Latent Tuberculosis AHS – G2063 | Providers | Blue Cross NC

  https://www.bluecrossnc.com/providers/policies-guidelines-codes/commercial/laboratory/updates/testing-for-diagnosis-of-active-or-latent-tuberculosis

  Testing for Diagnosis of Active or Latent Tuberculosis AHS – G2063 […] Infection by Mycobacterium tuberculosis (Mtb) results in a wide range of clinical presentations dependent upon the site of infection from classic signs and symptoms of pulmonary disease (cough great than two to three weeks’ duration, lymphadenopathy, fevers, night sweats, weight loss) to silent infection with a complete absence of signs or symptoms (Lewinsohn et al., 2017). […] Culture of Mtb is the gold standard for diagnosis as it is the most sensitive and provides an isolate for drug susceptibility testing and species identification (Bernardo, 2024). Nucleic acid amplification tests (NAAT) use polymerase chain reactions (PCR) to enable sensitive detection and identification of low density infections (Pai et al., 2004). Interferon-gamma release assays (IGRAs) are blood tests of cell-mediated immune response which measure T cell release of interferon (IFN)-gamma following stimulation by specific antigens such as Mycobacterium tuberculosis antigens (Lewinsohn et al., 2017; Menzies, 2024) used to detect a cellular immune response to M. tuberculosis which would indicate latent tuberculosis infection (LTBI) (Pai et al., 2014).

• #12 Tuberculosis Diagnosis: Current, Ongoing, and Future Approaches

  https://www.mdpi.com/2079-9721/12/9/202

  Chest radiography/chest X-ray (CXR) is very useful for TB diagnosis, particularly in resource-limited settings, showing high sensitivity in detecting PTB but limited specificity. According to the World Health Organization (WHO), this technique exhibits a sensitivity ranging from 87% to 98% and is considered a valuable tool for screening PTB. Furthermore, the rise of AI, particularly deep learning algorithms, has revolutionized TB detection, showing superior performance in both screening and diagnosis. […] M. tuberculosis is classified as a slow-growing mycobacteria, requiring seven days to six weeks to produce visible colonies on solid media. The procedure for culturing M. tuberculosis must be performed only in Biosafety Level 3 or 4 laboratories due to the high transmissibility of the mycobacteria, which is a limiting diagnostic capacity in many low and middle-income countries. Despite the time-consuming nature of culture, it remains the gold standard for diagnosing TB and monitoring TB treatment, offering advantages in identifying the pathogen and the antimicrobial susceptibility profile determination.

• #12 Tuberculosis Diagnosis: Current, Ongoing, and Future Approaches

  https://www.mdpi.com/2079-9721/12/9/202

  Emerging as alternatives to traditional TST, TBSTs like Cy-Tb™ and Diaskintest® offer improved specificity and sensitivity for TB diagnosis. These TBSTs represent a promising advancement in TB diagnosis, offering improved accuracy and potentially reducing limitations associated with the traditional TST. […] Recent studies showcase promising advancements in TB diagnostics, including the Cepheid MTB-HR cartridge, which identifies a three-gene transcriptomic signature, and the CAPTURE-XT technology, which uses dielectrophoresis to isolate M. tuberculosis from sputum. These studies offer hope for improved TB diagnosis, particularly in challenging settings. […] In summary, this review addresses the multiple approaches to diagnosing tuberculosis, focusing on pulmonary tuberculosis. Despite the availability of several molecular testing techniques, they are not accessible in various settings, especially in low- and middle-income countries. When feasible, the scenario of tuberculosis diagnosis can be improved with molecular testing without neglecting culture-based methods and SSM, thus improving specific identification of the etiological agent and the drug susceptibility testing.

• #13 Diagnosing Tuberculosis | NYU Langone Health

  https://nyulangone.org/conditions/tuberculosis/diagnosis

  NYU Langone physicians are experienced at recognizing tuberculosis, an infectious disease caused by the bacterium Mycobacterium tuberculosis. […] To diagnose tuberculosis, an NYU Langone pulmonologist takes a medical history and conducts a physical exam. […] A sputum culture is the primary test used to diagnose tuberculosis. […] If a sputum culture appears to test positive, doctors perform a polymerase chain reaction (PCR) test to confirm that the organisms seen are tuberculosis bacteria. […] In a chest X-ray, electromagnetic radiation forms an image of the organs in your chest, such as your heart and lungs. An X-ray can detect damage in the lungs, which may indicate tuberculosis. […] If a chest X-ray does not produce a clear enough image or is not definitive, your doctor may order a CT scan. […] Rarely, a doctor might suspect a person has tuberculosis despite negative sputum tests and negative PCR test results. In this case, he or she may perform a bronchoscopy.

• #14 Ways to Diagnose Tuberculosis (TB) and Recommended Tests | Suburban Diagnostics

  https://suburbandiagnostics.com/blog/diagnosis-of-tuberculosis-past-present-future/?srsltid=AfmBOoobn8FyM5zK6ZITuMncD7ER3MMrKE6gWvooMFp02xiKN1dAIw21

  Chest X-ray (CXR) is a screening tool and are used as a diagnostic aid to differentiate between primary and secondary tuberculosis. Chest X-ray can help in the detection of pulmonary TB but do not provide any etiological diagnosis. It also cant detect latent infection.(2) […] Microscopic evaluation of stained smears made from sputum, urine or aspirated body fluids has been a rapid and inexpensive screening method for mycobacteria within clinical specimens for over 100 years and even today, in resource-poor settings, the diagnosis of TB relies on Ziehl-Neelsen smear microscopy with the light microscope. Smear microscopy with the light microscope is a relatively insensitive methodology for the diagnosis of TB and only detects about 60-70% of the TB cases.(1) […] The gold standard test for the diagnosis of TB is the isolation of MTB on a culture medium. Until the early nineties culturing was usually done on solid egg-based media like Lowenstein Jensen (LJ medium). A drawback of culturing on these solid media is that MTB is a slow-growing organism with a generation time of 1415 hours and the colonies appear only in about two weeks and sometimes may be delayed up to 68 weeks.(2)

• #15 Azthena logo with the word Azthena

  https://www.news-medical.net/health/Tuberculosis-Diagnosis.aspx

  There are several investigations that may be used to diagnose tuberculosis. This may depend on the type of tuberculosis that is suspected. […] A Chest X ray shows the lesion within the lungs. […] The phlegm or mucus is collected from the patient. It is placed onto a glass slide and stained with a special dye called the Ziehl-Neelson stain and then viewed under the microscope. The tubercle bacilli show up as tiny red thread like organisms. […] For examination of sputum at least 3 spontaneous sputum samples need to be examined for culture and microscopy. […] In patients with tuberculosis suspected outside the lungs several tests are suggested. […] Those with suspected tuberculosis of the nervous system or of the brain and meninges (layers of cells that cover the brain and the spinal cord) also need a lumbar puncture. […] Diagnosis that need to be ruled out while confirming tuberculosis include:- Cancers, Lymphoma, Pneumonia, Fibrotic lung disease (e.g. Sarcoidosis, silicosis etc.), Diabetes.

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  Evidence shows that the diagnostic accuracy of LED microscopy is comparable to that of conventional fluorescence microscopy and it surpasses that of conventional Ziehl-Neelsen microscopy (by an average of 10%). Therefore, WHO recommends replacing conventional fluorescence microscopy with LED microscopy, and that LED microscopy should be phased in as an alternative to conventional ZiehlNeelsen light microscopy in all settings, prioritizing high-volume laboratories (WHO, 2015b). […] Mycobacteria can be cultured in specific solid or liquid media. Bacterial growth can be identified visually (that is, by identifying specific characteristics) or by automated detection of its metabolism. All positive mycobacterial cultures must be tested to confirm the identification of M. tuberculosis complex (MTBC) (WHO, 2015b).

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  The reference standard for diagnosis of any TB infection is isolation of M. tuberculosis (Pai et al., 2016). The isolate recovered should be identified according to the Clinical and Laboratory Standards Institute guidelines (Institute, 2018) and the American Society for Microbiology Manual of Clinical Microbiology (Lewinsohn et al., 2017; Woods et al., 2015), and all United States jurisdictions require submission of culture isolates identified as M. tuberculosis for confirmation of identification and drug susceptibility testing (Taylor et al., 2005). Positive cultures are also reported to public health authorities for oversight and case management (Bernardo, 2024). […] Cruciani et al. (2004) performed a meta-analysis of 10 studies (1381 strains from 14,745 clinical specimens) which found that both liquid and solid culture media methods are highly specific (99%). Liquid culture methods are more sensitive (81.5-85.8%) and have a shorter time to detection (13.2 15.2 day) than solid media but are more prone to contamination (4% 9%). Solid media has a sensitivity of 76% and averages 25.8 days for detection. The use of both culture methods increases the overall sensitivity to 87.7% 89.7%.

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  Nucleic acid amplification techniques (NAAT) have been developed for rapid diagnosis of TB. Two major tests are available, the Amplified Mycobacterium tuberculosis Direct (MTD) test and the Xpert MTB/RIF test. NAAT-based assays are more sensitive than smear, but less sensitive than culture, with a reported sensitivity of 96% and specificity of 99% (Greco et al., 2006; Lewinsohn et al., 2017). NAAT testing has 95% positive predictive value in the setting of AFB smear-positive specimens for distinguishing tuberculous from nontuberculous mycobacteria, and it can establish the presence of tuberculosis in 50 to 80% of AFB smear-negative specimens (Cheng et al., 2005). NAAT does not replace the roles of AFB smear and culture (Ling et al., 2008) in the diagnostic algorithm for tuberculosis and results must be interpreted in conjunction with AFB smear results while mycobacterial culture is pending (CDC, 2009; Lewinsohn et al., 2017).

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  Recommendation 1 is extrapolated to children for sputum, although the tests are expected to be less sensitive in children. […] Regarding first-line LPAs [line probe assays]: For persons with a sputum smear-positive specimen or a cultured isolate of MTBC, commercial molecular LPAs may be used as the initial test instead of phenotypic culture-based DST to detect resistance to rifampicin and isoniazid. (Conditional recommendation, moderate certainty in the evidence for the tests accuracy) […] The WHO clarifies the above recommendation with the following remarks: These recommendations apply to the use of LPAs for testing sputum smear-positive specimens (direct testing) and cultured isolates of MTBC (indirect testing) from both pulmonary and extrapulmonary sites. LPAs are not recommended for the direct testing of sputum smear-negative specimens. These recommendations apply to the detection of MTBC and the diagnosis of MDR-TB, but acknowledge that the accuracy of detecting resistance to rifampicin and isoniazid differs and, hence, that the accuracy of a diagnosis of MDR-TB is reduced overall. These recommendations do not eliminate the need for conventional culture-based DST, which will be necessary to determine resistance to other anti-TB agents and to monitor the emergence of additional drug resistance. Conventional culture-based DST for isoniazid may still be used to evaluate patients when the LPA result does not detect isoniazid resistance. This is particularly important for populations with a high pretest probability of resistance to isoniazid. These recommendations apply to the use of LPA in children based on the generalization of data from adults. (WHO, 2021)

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  For individuals whose sputum is AFB smear positive or Hologic Amplified MTD positive, molecular-based drug susceptibility testing is considered MEDICALLY NECESSARY when one of the following criteria is met: The individual has been treated for TB in the past. The individual was born in or has lived for at least 1 year in a foreign country with at least a moderate TB incidence ( 20 per 100,000) or a high primary multi-drug resistant (MDR)-TB prevalence ( 2%). The individual is a contact of an individual with MDR-TB. The individual is HIV infected. […] Repeat drug susceptibility testing is considered MEDICALLY NECESSARY in any of the following situations: For individuals whose sputum cultures remain positive after 3 months of treatment. When there is bacteriological reversion from negative to positive.

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  Rationale Tuberculosis (TB) continues to be a major public health threat globally, causing an estimated 10.0 million new cases and 1.2 million deaths from TB among HIV-negative individuals and 208,000 deaths among HI-positive people in 2019 (WHO, 2020), with the emergence of multidrug resistant strains only adding to the threat (Dheda et al., 2014). The lungs are the primary site of infection by Mtb and subsequent TB disease. Onset of symptoms is usually gradual with a persistent cough being most frequently reported (95%) followed by the typical symptoms of fever (75%), night sweats (45%) and weight loss (55%) (Heemskerk et al., 2015). Clinical manifestations include primary TB, reactivation TB, laryngeal TB, endobronchial TB, lower lung field TB infection, and tuberculoma (Bernardo, 2024). Extrapulmonary infection represents approximately 20% of cases of active TB with an additional 7% having concurrent pulmonary and extrapulmonary infections (Peto et al., 2009).

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  For individuals with pleural effusion, pericardial effusion, or ascites and suspected TB infection, cell counts, protein, glucose, and lactate dehydrogenase (LDH) concentrations of cerebrospinal, pleural, peritoneal, pericardial, and other fluids is considered MEDICALLY NECESSARY. […] In HIV-infected patients with CD4 cell counts 100 cells/microL who have signs and symptoms of tuberculosis, urine-based detection of mycobacterial cell wall glycolipid lipoarabinomannan (LAM) is considered MEDICALLY NECESSARY. […] For individuals with active tuberculosis, IGRA is considered NOT MEDICALLY NECESSARY for patients with active tuberculosis. […] Simultaneous ordering of any combination of direct probe, amplified probe, and/or quantification for the same organism in a single encounter is considered NOT MEDICALLY NECESSARY.

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  Adenosine deaminase (ADA) and interferon-gamma (IFN- ) levels in cerebrospinal, pleural, peritoneal, and pericardial fluids have been studied in the diagnosis of extrapulmonary TB. In 2017, a joint review by the ATS, IDSA, and CDC found the sensitivity of ADA in these fluids to be 79% and the specificity to be 83% for TB. The sensitivity of IFN- in these fluids was 89% and the specificity was 97%. However, the authors remarked that neither the ADA level nor the IFN- level provide a definitive diagnosis of TB disease (Lewinsohn et al., 2017). […] De Groote et al. (2017) developed a panel based on proteomic analysis. A total of 1,470 serum samples were collected from patients with symptoms and signs suggestive of active pulmonary TB that were systematically confirmed or ruled out for TB by culture and clinical follow-up. Six protein biomarkers were identified: SYWC, kallistatin, complement C9, gelsolin, testican-2, and aldolase C, which performed well in a training set (area under curve = 0.92) to distinguish between TB and non-TB. It was also found to have 90% sensitivity and 80 % specificity. The authors concluded that their panel warrants diagnostic development on a patient-near platform (De Groote et al., 2017).

• #16 Testing for Diagnosis of Active or Latent Tuberculosis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/testing-for-diagnosis-of-active-or-latent-tuberculosis/

  Finally, the WHO published an extensive guideline on the diagnosis of tuberculosis. Some relevant recommendations and comments are listed below: Recommendations on Xpert MTB/RIF [Mycobacterium tuberculosis/rifampicin] and Xpert Ultra as initial tests in adults and children with signs and symptoms of pulmonary TB: In adults with signs and symptoms of pulmonary TB, Xpert MTB/RIF should be used as an initial diagnostic test for TB and rifampicin-resistance detection in sputum rather than smear microscopy/culture and phenotypic DST [drug susceptibility testing]. (Strong recommendation, high certainty of evidence for test accuracy; moderate certainty of evidence for patient-important outcomes) In children with signs and symptoms of pulmonary TB, Xpert MTB/RIF should be used as an initial diagnostic test for TB and rifampicin-resistance detection in sputum, gastric aspirate, nasopharyngeal aspirate and stool rather than smear microscopy/culture and phenotypic DST. (Strong recommendation, moderate certainty for accuracy in sputum; low certainty of evidence for test accuracy in gastric aspirate, nasopharyngeal aspirate and stool) In adults with signs and symptoms of pulmonary TB and without a prior history of TB (5 years) or with a remote history of TB treatment (5 years since end of treatment), Xpert Ultra should be used as an initial diagnostic test for TB and for rifampicin-resistance detection in sputum, rather than smear microscopy/culture and phenotypic DST. (Strong recommendation, high certainty of evidence for test accuracy) In adults with signs and symptoms of pulmonary TB and with a prior history of TB and an end of treatment within the last 5 years, Xpert Ultra may be used as an initial diagnostic test for TB and for rifampicin-resistance detection in sputum, rather than smear microscopy/culture and phenotypic DST. (Conditional recommendation, low certainty of evidence for test accuracy) In children with signs and symptoms of pulmonary TB, Xpert Ultra should be used as the initial diagnostic test for TB and detection of rifampicin resistance in sputum or nasopharyngeal aspirate, rather than smear microscopy/culture and phenotypic DST. (Strong recommendation, low certainty of evidence for test accuracy in sputum; very low certainty of evidence for test accuracy in nasopharyngeal aspirate)

• #17 Frontiers | Improved Conventional and New Approaches in the Diagnosis of Tuberculosis

  https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.924410/full

  The clinical samples can be used for mycobacterial culture (10^2 bacilli•mL^-1 of sputum); cultivation is still the gold standard for TB diagnosis. M. tuberculosis is usually cultured on a solid medium, where it can be further identified and tested for drug sensitivity, providing to clinicians an effective antibacterial treatment guidance. The liquid culture systems such as BACTEC MGIT 960, VersaTREK, and MB/BacT Alert 3D allow the detection of M. tuberculosis in a few days. The BACTEC MGIT 960 automated culture system monitors the oxygen quenching fluorescence, and the signal is detected once the mycobacteria grow in the tube. Hasan et al. found that MGIT 960 is effective in the quick detection of mycobacteria and early TB diagnosis than L-J solid medium. The VersaTREK system is sensitive to pressure variation; thus, it detects the growth of the inoculated specimen by measuring the pressure change above the broth medium. The MB / BacT Alert 3D system uses a colorimetric carbon dioxide sensor to detect the growth of M. tuberculosis. Considering the slow growth of the M. tuberculosis complex (MTBC), most cultures positive for MTCB occur at least in 1 week, while a culture negative for MTCB occurs in 8 weeks.

• #17 Frontiers | Improved Conventional and New Approaches in the Diagnosis of Tuberculosis

  https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.924410/full

  GeneXpert MTB/RIF is the most widely used detection method in molecular diagnostics. It is a semi-nested real-time fluorescent PCR for the detection of M. tuberculosis and rifampin resistance simultaneously. The Xpert MTB/RIF Ultra developed based on Xpert MTB/RIF increases two different multi-copy amplification targets and a larger DNA reaction chamber. The limit for Xpert Ultra is increased to 15.6 CFU/ml compared to the detection limit of 112.6 CFU/ml of Xpert MTB/RIF. This technology directly detects MTBC DNA in sputum or concentrated sputum deposits as well as rifampin resistance, producing results within 2 hours. In December 2010, the World Health Organization recommended Xpert MTB/RIF in the diagnosis of TB and drug resistance, especially in HIV patients and suspected patients with multidrug-resistant TB. In consideration of high demands for professional testing personnel and supporting infrastructure, the primary medical institutions have difficulties to meet the above requirements for Xpert MTB/RIF and ensure the quality of test results.

• #17 Frontiers | Improved Conventional and New Approaches in the Diagnosis of Tuberculosis

  https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.924410/full

  Loop-mediated isothermal amplification is a type of Nucleic Acid Amplification Test that employs DNA polymerase and a set of specially designed primers to detect the presence of pathogenic DNA from a patient sample. The SS-LAMP is specially designed with a set of six specific primers to identify eight different regions on the MTBC-specific repeat insertion sequence 6,110 (IS6110), which is qualified to directly detect the DNA of MTBC from liquefied sputum samples. A validation study of the method was performed using 157 liquefied sputum specimens from Moroccan suspected TB patients. SS-LAMP analysis is faster, with a specificity of 99.14% and a sensitivity of 82.93% compared with the conventional L-J solid culture method. LAMP method is suitable for areas where medical resources are relatively scarce.

• #17 Frontiers | Improved Conventional and New Approaches in the Diagnosis of Tuberculosis

  https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.924410/full

  Digital PCR (dPCR) is a new type of nucleic acid quantification technology that requires very small amounts of target molecules, and it performs the absolute quantification without the need for a standard curve. Therefore, dPCR is precise and sensitive, and most importantly, it detects single copies of DNA. The dPCR samples can be sputum, blood, formalin fixed paraffin embedded tissue, and exhaled breath. The drug sensitivity testing can also be performed by this method. IS6110 is a common target for dPCR amplification, but when combined with IS1081 and IS6110, the dPCR sensitivity is higher than IS6110 qPCR, thus improving the diagnosis of smear-negative TB. This method has been demonstrated as useful for studying in the case of lung, extrapulmonary, latent TB infection, and active TB, though more prone to error in the hands of inexperienced users.

• #18 Mycobacterium tuberculosis – Tuberculosis | Choose the Right Test

  https://arupconsult.com/content/mycobacterium-tuberculosis

  The CDC recommends performing a NAAT on the initial respiratory specimen from patients with suspected pulmonary TB. NAATs are rapid and highly specific, although they are often less sensitive than culture. A NAAT, unlike an AFB smear, can distinguish MTB from NTM. A positive NAAT result with or without a positive AFB smear is considered sufficient evidence for TB diagnosis. […] Mycobacterial culture is a recommended test for the diagnosis of TB, and a positive culture is considered confirmatory. […] Culture-based drug susceptibility testing is considered the gold standard to identify drug-resistant TB.

• #19 2.2 Diagnostic testing

  https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/tb-reports/global-tuberculosis-report-2023/tb-diagnosis—treatment/2.2-diagnostic-testing-for-tb

  An essential step in the pathway of tuberculosis (TB) care is rapid and accurate testing. Since 2011, rapid molecular tests that are highly specific and sensitive have revolutionized the TB diagnostic landscape, which previously relied upon more traditional microscopy and culture methods. […] Bacteriological confirmation of TB is necessary to test for resistance to anti-TB drugs. Such testing can be done using rapid molecular tests, phenotypic susceptibility testing or (at reference-level laboratories) genetic sequencing. […] In general in 2022, levels of bacteriological confirmation were highest in high-income countries (median, 89%), where there is wide access to the most sensitive diagnostic tests, and lowest in low-income countries (median, 71%). […] This is particularly needed in the Democratic Peoples Republic of Korea, Mozambique, Myanmar, Pakistan, Papua New Guinea, the Philippines, the United Republic of Tanzania and Zambia, where levels of bacteriological confirmation remained around or below 50% in 2022.

• #19 2.2 Diagnostic testing

  https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/tb-reports/global-tuberculosis-report-2023/tb-diagnosis—treatment/2.2-diagnostic-testing-for-tb

  Globally in 2022, a WHO-recommended rapid diagnostic test (WRD) was used as the initial diagnostic test for 47% (3.5 million) of the 7.5 million people newly diagnosed with TB in 2022. […] Expanding access to TB diagnosis using rapid tests should be a top priority in many countries. […] The percentage of people initially tested with a WRD who had a positive test result provides an indication of the level of case-finding efforts. […] The number of WRDs used per person notified as a TB case also provides an indication of the level of diagnostic effort based on rapid tests. […] Bacteriological confirmation of TB is necessary to test for drug-resistant TB. […] The global and regional coverage of testing for susceptibility to fluoroquinolones, which is necessary to determine the most appropriate treatment regimen for people with RR-TB, is lower than the coverage of testing for RR-TB. […] Further country-specific details about diagnostic testing for TB, HIV-associated TB and anti-TB drug resistance are available in the Global tuberculosis report app and country profiles.

• #20 Pulmonary tuberculosis – Symptoms, diagnosis and treatment | BMJ Best Practice US

  https://bestpractice.bmj.com/topics/en-us/165

  Pulmonary tuberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. […] If pulmonary TB is suspected, the patient should be isolated, a chest x-ray obtained, and three sputum samples collected for acid-fast bacilli smear and culture; nucleic acid amplification test should be performed on at least one respiratory specimen. […] Diagnostic tests include chest x-ray, sputum acid-fast bacilli smear, sputum culture, CBC (complete blood count), and nucleic acid amplification tests (NAAT). […] Tests to consider include gastric aspirate, bronchoscopy and bronchoalveolar lavage, stool testing, drug susceptibility testing, genotyping, HIV test, lateral flow urine lipoarabinomannan (LF-LAM) assay, CT of chest, tuberculin skin testing, interferon-gamma release assays, and TB antigen-based skin tests (TBSTs).

• #21 Tuberculosis: Guidelines for Diagnosis from the ATS, IDSA, and CDC | AAFP

  https://www.aafp.org/pubs/afp/issues/2018/0101/p56.html

  For adults with suspected pulmonary TB who cannot provide sputum or whose sputum was negative on AFB smear, sputum induction is recommended over flexible bronchoscopy for initial sampling. […] In persons with suspected extrapulmonary TB, cell counts and chemistries should be performed on fluid specimens (e.g., pleural or cerebrospinal fluid). […] An AFB smear and NAAT are also recommended; a positive result on either can be reasonable evidence of disease, but a negative result on either cannot exclude disease, because of the high false-negative rate. […] In persons with suspected pleural, peritoneal, or pericardial TB, or tuberculous meningitis, measurement of adenosine deaminase is recommended, with measurement of free interferon gamma also performed in those with suspected pleural or peritoneal TB.

• #22 Revisiting tuberculosis diagnosis: the prospect of urine lipoarabinomannan assay as a diagnostic tool in people living with human immunodeficiency virus | Beni-Suef University Journal of Basic and Applied Sciences | Full Text

  https://bjbas.springeropen.com/articles/10.1186/s43088-024-00578-7

  Tuberculosis, since its discovery has become a global health burden, continuously spreading across the nations of the earth with increased mortality. […] The detection efficacy of urine lipoarabinomannan assay as a prospect in tuberculosis diagnosis in HIV-positive patients was assessed in this study. […] The use of urinary LAM in HIV-positive patients is a helpful tool for TB screening. It also has a promising ability for early TB diagnosis in the study group and other TB-associated disease conditions in resource-deprived settings. […] The Alere determine urine lateral flow (LF)lipoarabinomannan (LAM) assay is an immunocapture point-of-care test that detects mycobacterial LAM antigens in urine. It is the WHO recommended urine test for TB diagnosis. […] In this study, we assessed the diagnostic efficacy of the urine-based AlereLAM test as a rule-in screening test for early TB detection in patients with HIV immunosuppression and the impact of LF-LAM implementation on TB mortality in resource-deprived settings. […] The reactivity of determine TB Ag LAM was 34.1% and non-reactive, 65.9%, respectively. […] The findings from this study suggest that urinary LAM assay could serve as a solution-driven option to addressing the challenge of the late detection of TB in HIV in resource-deprived settings.

• #23 TB Diagnosis and Treatment (For Clinicians) | Wisconsin Department of Health Services

  https://www.dhs.wisconsin.gov/tb/diagnosis-treatment.htm

  Tuberculosis (TB) in Wisconsin is rare. The majority of people with TB in Wisconsin acquire the infection outside of Wisconsin. Diagnosis and treatment of TB disease or latent tuberculosis infection (LTBI) should start with a risk assessment, symptom evaluation, and testing. […] The use of tuberculin skin test (TST) or interferon gamma release assay (IGRA) blood test can aid in diagnosing TB infection, but cannot differentiate between latent infection and active TB disease. Medical evaluation, radiography, and the collection of specimens for microbiology are often needed to complete the diagnosis. […] People with clinical signs and symptoms of TB disease, but negative IGRA or TST, should still be evaluated, especially if TB risk factors are present. […] State and local public health departments are responsible for ensuring that adequate and appropriate TB diagnostic and treatment services are accessed.

• #23 TB Diagnosis and Treatment (For Clinicians) | Wisconsin Department of Health Services

  https://www.dhs.wisconsin.gov/tb/diagnosis-treatment.htm

  In collaboration with the medical provider, public health departments provide the following services for all persons with suspect or active TB disease and LTBI: Facilitation of comprehensive TB patient evaluation, testing, and treatment. […] Testing for TB infection usually means performing a skin test (TST) or IGRA (QuantiFERON or T.Spot.TB) blood test. IGRAs are preferred, especially for persons born outside the U.S. due to higher test specificity. […] Persons who are suspected of having active TB disease may have false negative IGRA or TST results. Additional methods of evaluation are needed to diagnose TB disease. […] All patients with a newly confirmed positive IGRA or TST test should be evaluated with a chest radiograph (chest x-ray or chest CT). […] Persons who are suspected to have pulmonary TB disease, either because of abnormal chest radiograph or TB symptom evaluation, should have sputum specimens collected and sent to the laboratory for smear, culture, and molecular testing (PCR), if indicated. […] Both LTBI and active TB disease are treatable. Many regimens are available, depending on the person’s medical history and the drug (antibiotic) susceptibility patterns, if known.

• #24 Diagnosis of pulmonary tuberculosis in adults – UpToDate

  https://www.uptodate.com/contents/diagnosis-of-pulmonary-tuberculosis-in-adults

  Diagnosis of pulmonary tuberculosis in adults […] Prompt diagnosis of active TB facilitates timely therapeutic intervention and minimizes community transmission. […] The diagnosis of pulmonary TB is definitively established by isolation of M. tuberculosis from a bodily secretion or fluid (eg, culture of sputum, bronchoalveolar lavage, or pleural fluid) or tissue (eg, pleural biopsy or lung biopsy). […] Additional diagnostic tools include sputum acid-fast bacilli (AFB) smear and nucleic acid amplification (NAA) testing; a positive NAA test (with or without AFB smear positivity) in a person at risk for TB (who has no prior history of treatment for pulmonary TB) is considered sufficient for diagnosis of TB. […] Radiographic studies are important supportive diagnostic tools.

• #25 TB Testing and Diagnosis | Vermont Department of Health

  https://www.healthvermont.gov/disease-control/tuberculosis/tb-testing-and-diagnosis

  There are two types of tests used to detect tuberculosis infection: the TB skin test and the TB blood test. A positive test result indicates that a person is infected with TB bacteria. It does not tell whether a person has a latent TB infection or has TB disease. Other tests, such as a chest x-ray, must be used to determine if a person has TB disease. […] A health care provider should evaluate anyone who has TB symptoms or a positive TB test result for TB disease. If a person has a negative TB test result, but still has symptoms, they should still be evaluated for TB. […] A person is diagnosed with a latent TB infection if they have a positive TB test but a medical evaluation does not indicate TB disease. […] TB is diagnosed through many tests including a physical examination, medical history, and a chest x-ray. If someone is diagnosed, their health care provider will recommend multiple medications.

• #26 Diagnosing Tuberculosis | Tuberculosis (TB) | CDC

  https://www.cdc.gov/tb/testing/diagnosing-tuberculosis.html

  A positive test result for tuberculosis (TB) infection means you have TB germs in your body. […] Your health care provider will do other tests to determine if you have inactive TB (also called latent TB infection) or active TB disease. […] Anyone with symptoms of TB disease or a positive TB blood test or TB skin test result should be evaluated by a health care provider for TB disease. […] A health care provider may diagnose you with inactive TB or active TB disease based on your: Medical history, Physical examination, Test for TB infection (TB blood test or TB skin test), Chest x-ray, Laboratory tests to see if TB germs are present (sputum smear and culture), Laboratory tests for drug resistance. […] If you have a positive TB blood test or TB skin test, but your health care provider does not find evidence of TB disease after a medical evaluation, you may be diagnosed with inactive TB.

• #27 Tuberculosis – Eradication & Prevention

  https://www.gatesfoundation.org/our-work/programs/global-health/tuberculosis

  Of the estimated 10 million new cases of TB worldwide each year, 3 million go undiagnosed and/or unreported. We are developing less expensive, more effective diagnostic tools that can reach more people who are infected with TB. […] One new technology we helped fund, the GeneXpert diagnostic test, has led to an increase in overall TB case finding and has the potential to more effectively guide proper treatment. It better detects drug-resistant cases of TB from sputum samples, helping providers select the most appropriate treatment. […] We continue to support development of next-generation TB diagnostic tests based on samples that are easier to obtain than sputum, including blood, urine, and potentially even breath or sweat. While these techniques are in the early stages of development, new diagnostics could improve TB detection, facilitate faster treatment, and reduce transmission.

• #28 Early diagnosis and meta-agnostic model visualization of tuberculosis based on radiography images | Scientific Reports

  https://www.nature.com/articles/s41598-023-49195-x

  Despite being treatable and preventable, tuberculosis (TB) affected one-fourth of the world population in 2019, and it took the lives of 1.4 million people in 2019. […] As it is an infectious bacterial disease, the early diagnosis of TB prevents further transmission and increases the survival rate of the affected person. […] One of the standard diagnosis methods is the sputum culture test. […] Using posterior-anterior chest radiographs (CXR) facilitates a rapid and more cost-effective early diagnosis of tuberculosis. […] We proposed an early TB diagnosis system (tbXpert) based on deep learning methods. […] The proposed system demonstrates a maximum testing accuracy of 99.2%, a sensitivity of 98.9%, a specificity of 99.6%, a precision of 99.6%, and an AUC of 99.4%, all of which are pretty high when compared to current state-of-the-art deep learning approaches for the prognosis of tuberculosis.

• #29 Finding the missed millions: innovations to bring tuberculosis diagnosis closer to key populations | BMC Global and Public Health | Full Text

  https://bmcglobalpublichealth.biomedcentral.com/articles/10.1186/s44263-024-00063-4

  Currently, LAM assay is only recommended for testing in PLHIV with low CD4 counts and report limited sensitivity in the wider population, but newer generation assays are under evaluation, including a third-generation Fujifilm SILVAMP TB LAM II (FujiLAM) which is expected to have much improved sensitivity and could potentially be used amongst people with TB who do not have HIV. […] The improved performance of TB screening and diagnostic testing alone will not bridge the gap between the 10 million people who develop TB every year and the 7 million who are diagnosed, treated, and notified. […] We must work to bring different combinations of the best tests and use them in creative ways to reach those who are currently being missed by existing TB prevention and care services.

• #29 Finding the missed millions: innovations to bring tuberculosis diagnosis closer to key populations | BMC Global and Public Health | Full Text

  https://bmcglobalpublichealth.biomedcentral.com/articles/10.1186/s44263-024-00063-4

  Community-based ACF approaches have also exhibited socio-protective properties in their capacity to reduce catastrophic costs for people with TB and their households. […] Thus, it is vital that these activities are centred around bringing tests to where people are, rather than being reliant on and waiting for people with TB to seek care and attend diagnostic facilities. […] New tools are emerging that are designed for use at the PHC level and in the community. […] For diagnosis, battery-powered molecular testing platforms, lipoarabinomannan (LAM) urine lateral flow assays, and alternatives to sputum specimens, such as upper respiratory swabs and stool specimens, are being considered. […] The recommended specimen for most approved TB diagnostic assays is sputum. […] However, sputum can be difficult to produce and collect from adults and even more so in cases of subclinical TB and from key populations, such as children and PLHIV, whose specimens tend to have lower bacillary loads and who account for a disproportionate share of the missed millions.

• #30 The History of Tuberculosis Diagnostics – Co-Dx

  https://co-dx.com/history-of-tb-diagnostics/

  Tuberculin skin tests (or TSTs) to this day remain recommended by the U.S. CDC, especially for the identification of latent TB. […] In modern times, smear microscopy (growing a sputum sample from a patient suspected of containing TB in a culture, and then inspecting that culture under a microscope) using staining techniques from over a hundred years ago remains a common method of tuberculosis testing. […] The invention of PCR in the late 20th century opened new doors for detection of TB, and today the World Health Organization (WHO) recommends molecular diagnostics as the preferred frontline testing option. […] Despite this recommendation, fewer than 40% of all TB cases reported to the WHO in 2021 were detected using rapid molecular diagnostics. […] The authors emphasize the importance of changes such as shifting away from smear microscopy, of decentralizing molecular testing, lower-cost tests manufactured in low- and middle-income countries, and covering larger sections of the population in the years to come.

• #31 Towards a Lab-Free Tuberculosis Diagnosis – Treatment Action Group

  https://www.treatmentactiongroup.org/publication/towards-lab-free-tuberculosis-diagnosis/

  Tuberculosis (TB) remains a major challenge to public health globally, particularly in resource-poor settings. […] Although most cases of TB are curable, tuberculosis causes around 2 million deaths each year, in part due to late or missed diagnosis. The control and ultimate elimination of this disease, therefore, still rests on prompt diagnosis and therapeutic intervention to reduce ongoing transmission. Improving the performance of diagnostics and their availability is therefore key to reducing global morbidity and mortality from TB and thus achieving the Millennium Development Goals. […] Despite some progress in recent years, simple diagnostics for community-based diagnosis of TB in resource-poor settings are lacking, and funding remains inadequate. […] The limitations of existing diagnostics result in diagnostic delays that contribute to late or missed diagnoses, with serious consequences for disease progression and TB transmission, thus fueling the epidemic.

• #32 Tuberculosis (TB): Practice Essentials, Background, Pathophysiology

  https://emedicine.medscape.com/article/230802-overview

  Tuberculosis (TB) […] The primary screening method for TB infection (active or latent) is the Mantoux tuberculin skin test with purified protein derivative (PPD). An in vitro blood test based on interferon-gamma release assay (IGRA) with antigens specific to M tuberculosis also can screen for latent TB infection. Patients suspected of having TB should submit sputum for acid-fast bacilli (AFB) smear and culture. […] Obtain the following laboratory tests for patients with suspected TB: Acid-fast bacilli (AFB) smear and culture using sputum obtained from the patient. Absence of a positive smear result does not exclude active TB infection; AFB culture is the most specific test for TB. […] Other diagnostic tests may warrant consideration, including the following: Specific enzyme-linked immunospot (ELISpot), Nucleic acid amplification tests, Blood culture.

• #33 Tuberculosis (TB) – Infectious Diseases – MSD Manual Professional Edition

  https://www.msdmanuals.com/professional/infectious-diseases/mycobacteria/tuberculosis-tb

  The use of rapid molecular testing for TB and rifampin resistance has been shown to reduce the propagation of DR-TB. […] The new anti-TB drugs bedaquiline, delamanid, and pretomanid and the fluoroquinolone moxifloxacin are oral drugs highly active against drug-resistant strains using shorter treatment duration than other regimens. […] A three-drug regimen consisting of bedaquiline, pretomanid, and linezolid (known as the BPaL regimen) had favorable outcomes in an uncontrolled clinical trial of 109 people with extensively drug-resistant TB (XDR-TB) as well as treatment-intolerant or nonresponsive multidrug-resistant TB. […] The evolution of all-oral, shorter, better tolerated regimens for highly DR-TB is a landmark in global TB control, but a major commitment from countries to diagnose and effectively treat such cases and prevent their spread is still required.

• #34 Tuberculosis testing

  https://www.racgp.org.au/afp/2012/july/tuberculosis-testing

  Treating LTBI decreases the risk of progression to active TB by 60-90% and eliminates the potential for transmission. […] A positive IGRA suggests that the patient’s immune system recognises TB antigens. This may be due to either current infection or a remote past infection. Interferon gamma release assays do not diagnose active TB microbiological tests are needed. […] If a TST or IGRA are positive, then active disease must be excluded with chest X-ray and sputum for microscopy and culture.

• #35 Tuberculosis | Pioneering Diagnostics

  https://www.biomerieux.com/corp/en/our-offer/hospital-laboratory/patient-condition/tuberculosis.html

  Methods for diagnosing latent TB include the tuberculin skin test (TST) and interferon-gamma release assays (IGRA). Adequate diagnosis and treatment of latent tuberculosis infection is one of the critical components of the World Health Organizations End TB Strategy, essential to prevent the development of active tuberculosis disease and stop the spread of tuberculosis. […] For active tuberculosis infections, our RAL STAINER helps standardize AFB (Acid-fast bacteria) staining for sputum smear microscopy. […] Our VITEK MS and VITEK MS PRIME database includes Mycobacterium tuberculosis complex and is consistently expanding to add new emerging pathogens and clinically relevant species. […] For latent tuberculosis infection, our interferon gamma production detection test, VIDAS TB-IGRA, is simple, effective, and reliable. Its high sensitivity and specificity provide reliable results and an improved ability to detect Mycobacterium tuberculosis in infected individuals.

• #36 The Radiological Diagnosis of Pulmonary Tuberculosis (TB) in Primary Care

  https://clinmedjournals.org/articles/jfmdp/journal-of-family-medicine-and-disease-prevention-jfmdp-4-073.php?jid=jfmdp

  The common two confirmatory tests of active TB are sputum-smear microscopy (SSM) and Xpert MTB/RIF (XP). Nonetheless, most clinician’s judgment to reach a diagnosis of active TB is from symptoms inquiry questionnaire and chest radiography findings. […] The sensitivity and specificity of symptoms inquiry screening questionnaire are 77%, 66% respectively, while it is better in PPD 89%, 80% respectively; though it is higher in CXR reaches to 86%, 89% respectively. […] Whereas, the sensitivity and specificity of the two confirmatory tests are 61%, 98% in SSM, respectively; though it is higher in XP reaches to 90%, 99% respectively. […] In general, the physician should have a high index of suspicion of active TB lesion and should differentiate it from inactive TB lesion. […] Latent TB infection is an asymptomatic individual with a routine chest x-ray, and a negative sputum smear has a positive skin test (PPD/TST) or blood IGRA test result indicate previous TB infection.

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