Draft Recommendation Statement
Latent Tuberculosis Infection in Adults: Screening
November 22, 2022
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
- Update in Progress for Latent Tuberculosis Infection in Adults: Screening
|Asymptomatic adults at increased risk of latent tuberculosis infection||The USPSTF recommends screening for latent tuberculosis infection in populations at increased risk.||B|
Pathway to Benefit
To achieve the benefit of screening, it is important that persons who screen positive for LTBI receive followup and treatment.
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
In the United States, tuberculosis (TB) remains an important preventable disease, including active TB, which may be infectious, and latent TB infection (LTBI), which is asymptomatic and not infectious but can later progress to active disease. The precise prevalence rate of LTBI in the United States is difficult to determine; however, estimated prevalence is about 5.0%,1 or up to 13 million persons.2 TB is spread through respiratory transmission. Approximately 30% of persons exposed to Mycobacterium tuberculosis will develop LTBI3,4 and, if left untreated, approximately 5% to 10% of healthy, immunocompetent persons will progress to active TB disease.5,6 Rates of progression may be higher in persons with certain risk factors or medical conditions.
TB disproportionately affects certain populations in the United States, including Native Hawaiian/Pacific Islander, Asian, Hispanic/Latino, Native American/Alaska Native, and Black persons.7 Incidence of TB varies by geography8 and living accommodations,9 suggesting an association with social determinants of health.10,11 An effective strategy for reducing the transmission, morbidity, and mortality of active TB disease is the identification and treatment of LTBI.
The U.S. Preventive Services Task Force (USPSTF) concludes with moderate certainty that there is a moderate net benefit in preventing active TB disease by screening for LTBI in persons at increased risk for TB infection.
Patient Population Under Consideration
This recommendation applies to asymptomatic adults age 18 years or older at increased risk for TB (see the “Assessment of Risk” section for more information). It does not apply to adults with symptoms of TB or to children and adolescents.
According to the Centers for Disease Control and Prevention (CDC),12 TB infection or LTBI is an infection with M. tuberculosis in which the bacteria are alive but contained by the immune system. Persons with LTBI have no apparent symptoms, do not feel sick, cannot spread TB to others, and usually have a positive TB skin test or positive TB blood test reaction. Persons with LTBI may develop TB disease if they do not receive treatment for LTBI. Active TB or TB disease is an illness in which TB bacteria are multiplying and attacking a part of the body, usually the lungs. TB disease may be symptomatic (including weakness, weight loss, fever, no appetite, chills, sweating at night, bad cough, pain in the chest, or coughing up blood). A person with TB disease may be infectious and spread TB bacteria to others.
Assessment of Risk
Populations at increased risk for LTBI based on increased prevalence of active disease and increased risk of exposure include persons who were born in, or are former residents of, countries with increased TB prevalence and persons who live in, or have lived in, high-risk congregate settings (e.g., homeless shelters or correctional facilities). Clinicians can consult their local or state health departments for more information about populations at risk in their community since local demographic patterns may vary across the United States.
In 2020, 71.5% of all cases of active TB in the United States occurred among persons born outside the United States.13 According to the CDC, TB disease is common in most countries in Latin America, the Caribbean, Africa, Asia, Eastern Europe, and Russia.14 The most common countries of birth among persons living in the United States who were born outside the United States with new TB in 2020 were Mexico (18.0%), the Philippines (12.5%), India (10.4%), Vietnam (8.2%), and China (5.1%), accounting for 54.2% of total cases.15 Most of these cases are thought to be due to progression of latent infection to active TB disease rather than new transmission within communities.16-21
Persons who live in, or have lived in, high-risk congregate settings also have a higher prevalence rate of active TB and an increased risk for exposure. In 2020, 4.3% of TB disease cases diagnosed in persons age 15 years or older occurred in persons experiencing homelessness and 2.6% occurred in residents of correctional facilities.22 It is estimated that persons experiencing homelessness have an 11 times higher incidence of TB disease compared with persons who are not experiencing homelessness (36 cases per 100,000 population vs. 2.9 cases per 100,000 population, respectively, during 2011 to 2016).23
Other populations at increased risk for LTBI or progression to active disease include persons who have immunosuppression (e.g., persons living with HIV, patients receiving immunosuppressive medications such as chemotherapy or tumor necrosis factor-alpha inhibitors, and patients who have received an organ transplant) and patients with silicosis (a lung disease).9 However, given that screening in these populations may be considered standard care as part of disease management or indicated prior to the use of certain medications, the USPSTF did not review evidence on screening in these populations. Information on testing in these populations is addressed by other groups, such as the Office of AIDS Research at the National Institutes of Health,24 and in a guideline issued jointly by the American Thoracic Society, Infectious Diseases Society of America, and CDC.25 Some evidence from observational studies has explored the association between poorly controlled diabetes and progression of LTBI to active disease. However, there is insufficient evidence on screening for and treatment of LTBI in persons with diabetes for the USPSTF to make a separate recommendation for this important population.9,26
Persons who are contacts of individuals with active TB, healthcare workers, and workers in high-risk congregate settings may also be at increased risk of exposure. Because screening in these populations is conducted as part of public health or employee health surveillance, the USPSTF did not review the evidence in these populations. Clinicians seeking further information about testing for TB in these populations can refer to the “Additional Tools and Resources” and “Recommendations of Others” sections.
Two types of screening tests for LTBI are currently available in the United States: the tuberculin skin test (TST) and the interferon-gamma release assay (IGRA). The TST requires trained personnel to administer intradermal purified protein derivative and interpret the response 48 to 72 hours later.25,27 IGRA requires a single venous blood sample that measures the CD4 T-cell response to specific M. tuberculosis antigens and laboratory processing within 8 to 30 hours after collection. Three types of IGRA are currently approved by the U.S. Food and Drug Administration: T-SPOT.TB (Oxford Immunotec Global), QuantiFERON-TB Gold In-Tube (Qiagen), and QuantiFERON-Gold Plus (Qiagen).9
Diagnosis of LTBI is based on further clinical assessment of positive screening results and ruling out active TB.
The USPSTF found no evidence on the optimal frequency of screening for LTBI. In the absence of evidence, a reasonable approach is to repeat screening based on specific risk factors; screening frequency could range from one-time only screening among persons at low risk for future TB exposure to annual screening among those who are at continued risk of exposure.
Several antibiotics are available for the treatment of LTBI. Isoniazid (INH) was the first medication shown to prevent progression to active TB; however, concerns about hepatotoxicity and drug resistance resulting from low adherence with long courses of treatment have prompted exploration of shorter courses and in combination with other medications such as rifapentine (RPT) and rifampin (RIF). Current recommendations for the treatment of LTBI are available from the CDC.28
Screening with the TST requires that patients return 48 to 72 hours after administration of the skin test for interpretation of results. When placing a TST, clinicians should plan with patients accordingly to ensure they can return in time and that the facility is able to interpret the test results within the proper time frame. Screening with an IGRA requires obtaining a single venous blood sample, and patients do not need to return for interpretation of results. However, clinicians should be aware of processing requirements for blood samples and ensure that venous blood samples are drawn and can reach the laboratory for processing within the appropriate time frame (8 to 30 hours, depending on the test). Testing with IGRA may be preferable for persons who have received a Bacille Calmette–Guérin vaccination or persons who may be unlikely to return for TST interpretation.
Additional Tools and Resources
Information on estimated TB burden by country is available from the World Health Organization at its website (https://worldhealthorg.shinyapps.io/tb_profiles/?_inputs_&entity_type=%22country%22&lan=%22EN%22&iso2=%22AF%22) and through its annual Global Tuberculosis Report (https://www.who.int/publications/digital/global-tuberculosis-report-2021).
The CDC offers several resources and continuing education activities on LTBI for clinicians (https://www.cdc.gov/tb/education/provider_edmaterials.htm) as well as a Guide for Primary Health Care Providers (https://www.cdc.gov/tb/publications/ltbi/pdf/LTBIbooklet508.pdf). Resources for TB screening of health care personnel are also available (https://www.cdc.gov/tb/topic/infectioncontrol/healthCarePersonnel-resources.htm).
Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV are available through Clinical Info HIV.gov (https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/mycobacterium-0?view=full).
When final, this recommendation will replace the 2016 USPSTF recommendation on LTBI screening. In 2016, the USPSTF recommended screening for LTBI in populations at increased risk (B recommendation).29 The current draft recommendation is consistent with the 2016 USPSTF recommendation.
Scope of Review
The USPSTF commissioned a systematic evidence review9 to update its 2016 recommendation on screening for LTBI. The review focused on the benefits and harms of LTBI screening and treatment in asymptomatic adults seen in primary care, as well as the accuracy of LTBI screening tests. It did not include evidence on screening in persons for whom LTBI screening would be considered management of a specific condition (e.g., persons living with HIV), public health surveillance (i.e., tracing contacts of persons with active TB disease), surveillance of employees working in high-risk settings, or screening indicated prior to the use of specific immunosuppressive medications.
Accuracy of Screening Tests
There is no direct test for the diagnosis of latent infection with M. tuberculosis. In the absence of a reference standard for detection of LTBI, screening test performance is based on detection of disease in persons with known active TB and nondetection of disease in populations at low risk for the disease and presumed not to have LTBI or active TB.
Currently available TST and IGRA screening tests are moderately sensitive and highly specific for LTBI.9 The sensitivity and specificity of TST depends on the threshold used to determine positivity. Using a threshold of 5 mm induration, the pooled sensitivity of TST was 80% (12 studies; n=1,323) and the pooled specificity was 95% (3 studies; n=5,149).9 Using a threshold of 10 mm induration, the pooled sensitivity was 81% (15 studies; n=1,427) and the pooled specificity was 98% (8 studies; n=9,604).9 Last, using a threshold of 15 mm induration, the pooled sensitivity was 60% (9 studies; n=1,004) and the pooled specificity was 99% (10 studies; n=9,563).9
For IGRA tests, pooled sensitivity of the T-SPOT.TB test was 90% (37 studies; n=5,367) and pooled specificity ranged from 95% to 97% (2 studies; n=1,664).9 For QFT-GIT, pooled sensitivity was 81% (48 studies; n=7,055) and pooled specificity was 99% (3 studies; n=2,090).9 For QFT-Gold Plus, pooled sensitivity was 89% (11 studies; n=939) and specificity was 98% based on a single study (n=211).9 No eligible studies reported on the accuracy of sequential testing (TST followed by IGRA or IGRA followed by TST).
Additional studies reporting on the reliability of TST and IGRA screening tests suggest moderate to substantial agreement between two observers.9 Interrater reliability was higher for IGRA and varied by whether results were read manually or by automation.9
Benefits of Early Detection and Treatment
The USPSTF identified no randomized clinical trials that directly compared the benefits on health outcomes of LTBI-screened populations compared with unscreened populations. The International Union Against Tuberculosis (IUAT) trial,30 a randomized clinical trial of LTBI treatment published in 1982, compared INH with placebo in 27,830 European adults with fibrotic pulmonary lesions (but not active TB). Treatment with INH 300 mg daily for 24 weeks was associated with a decreased risk of developing active TB (relative risk [RR], 0.35 [95% CI, 0.24 to 0.52]), which translates to a number needed to treat of 112. The IUAT trial also suggested a potential reduction of risk of death from TB at 5 years with INH treatment (RR, 0.14 [95% CI, 0.01 to 2.78]).
More recent comparative effectiveness trials have compared other treatment regimens with INH alone to establish the noninferiority of other regimens in asymptomatic persons with positive TST or IGRA results.9 Two clinical trials compared treatment of LTBI with RIF vs. INH (n=6,910):9,31,32 eight vs. nine participants developed active TB in the RIF group vs. INH group, and there were 22 deaths (all-cause mortality) in the RIF group compared with 15 deaths in the INH group. Two clinical trials (n=7,149) have compared treatment of LTBI with RPT+INH vs. INH alone:9,33,34 30 vs. 34 deaths (all-cause mortality) in RPT+INH vs. INH-alone groups were reported across both studies and one trial (n=6,886) reported 5 vs. 10 cases of subsequent active TB in the RPT+INH group vs. INH-alone group. None of the treatment studies reported on transmission rates of TB.
Harms of Screening and Treatment
The USPSTF identified no studies that directly reported on the harms of screening. Potential hypothesized harms of screening include stigma associated with screening and diagnostic workup, as well as treatment of false-positive results. The IUAT trial reported on harms of treatment of LTBI with INH compared with placebo.30,35 An increased risk of hepatoxicity with INH 300 mg for 24 weeks of treatment was reported in the IUAT trial (RR, 4.59 [95% CI, 2.03 to 10.39]), translating to a number needed to harm of 279. Deaths due to hepatoxicity were rare; increased risk of death from hepatotoxicity was reported with an RR of 2.35 (95% CI, 0.12 to 45.46), translating to a number needed to harm of 6,947. There was also a greater risk of treatment discontinuation because of adverse events reported with INH (RR, 1.50 [95% CI, 1.18 to 1.89]) and a greater risk of gastrointestinal adverse events (RR, 1.33 [95% CI, 1.01 to 1.75]).
More recent trials have evaluated whether other treatment regimens, including lower doses or shorter durations of INH in combination with other medications, may be associated with lower risk of hepatotoxicity. Meta-analysis of three trials (n=7,339) that compared INH vs. RIF found a higher pooled RR of hepatotoxicity with INH (pooled RR, 4.22 [95% CI, 2.21 to 8.06]);9,31,32,36,37 deaths from hepatotoxicity were not reported in any treatment groups. Two trials reported on harms of RPT+INH vs. INH alone.9,33,34,38 The PREVENT TB study (n=7,731)33 reported a nonstatistically significant difference in Grade 3 or 4 hepatotoxicity between participants receiving RPT+INH and those taking INH alone (RR, 0.90 [95% CI, 0.75 to 1.08]); post-hoc analyses showed a smaller number of cases of hepatotoxicity attributable to the study drug in the RPT+INH group compared with the INH-alone group (RR, 0.16 [95% CI, 0.10 to 0.28]).38 The second trial (n=263)34 reported a nonstatistically significant decreased risk of clinically relevant hepatoxicity in the RPT+INH group compared with the INH-alone group (RR, 0.28 [95% CI, 0.06 to 1.34]); no deaths due to hepatoxicity were reported in either treatment group.
Recent trials also reported on discontinuation due to adverse events. There was a nonstatistically significant increase in discontinuation due to adverse events in a meta-analysis of three trials of INH vs. RIF (pooled RR, 2.25 [95% CI, 0.90 to 5.59]; 3 trials; n=7,339). Both the PREVENT TB study and a second trial of participants receiving RPT+INH vs. INH alone reported increased discontinuation due to adverse events in study participants in the RPT+INH group compared with INH alone; however, this was statistically significant in only one trial.9 Overall, study reports of gastrointestinal adverse events other than hepatotoxicity were heterogenous with mixed results.9
More research is needed on the following.
- Although risk factors for active TB disease are well described, studies are needed on the accuracy of risk assessment tools to help clinicians identify who is at increased risk for LTBI and who should receive screening.
- Evidence is needed to inform which populations should receive repeat screening for LTBI and how frequently.
- More research is needed to inform which screening strategies are more effective for certain patient populations.
The CDC, together with the American Thoracic Society and the Infectious Diseases Society of America, recommends screening for LTBI to identify persons who may benefit from treatment before progression to active TB infection.25,39 Joint guidelines from the American Academy of Pediatrics and American College of Obstetricians and Gynecologists recommend screening for latent TB in early pregnancy for women at high risk for TB, including those with recent TB exposure, HIV infection, risk factors increasing risk of progression to active disease (such as diabetes, lupus, cancer, alcoholism, and drug addiction), use of immune-suppressing drugs such as tumor necrosis factor-alpha inhibitors or chronic steroids, renal failure on dialysis, homelessness, living or working in long-term care facilities such as nursing homes and prisons, being medically underserved, and being born in a country with high prevalence of TB.40 The American Academy of Family Physicians supports the 2016 USPSTF recommendation on screening for LTBI.41
1. Miramontes R, Hill AN, Yelk Woodruff RS, et al. Tuberculosis infection in the United States: prevalence estimates from the National Health and Nutrition Examination Survey, 2011-2012. PLoS One. 2015;10(11):e0140881.
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6. Ferebee SH. Controlled chemoprophylaxis trials in tuberculosis. A general review. Bibl Tuberc. 1970;26:28-106.
7. Centers for Disease Control and Prevention. Reported Tuberculosis in the United States, 2020; Table 2. Tuberculosis Cases, Percentages, and Incidence Rates per 100,000 Population by Hispanic Ethnicity and Non-Hispanic Race: United States, 1993–2020. Accessed October 18, 2022. https://www.cdc.gov/tb/statistics/reports/2020/table2.htm
8. Centers for Disease Control and Prevention. Reported Tuberculosis in the United States, 2020; Table 29. Tuberculosis Cases and Incidence Rates per 100,000 Population, Ranked and Grouped by Number of Cases: United States and the District of Columbia, 2020 and 2019. Accessed October 18, 2022. https://www.cdc.gov/tb/statistics/reports/2020/table29.htm
9. Jonas DE, Riley S, Lee L, et al. Screening for Latent Tuberculosis Infection in Adults: An Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 226. Rockville, MD; Agency for Healthcare Research and Quality; 2022. AHRQ Publication No. 22-05298-EF-1.
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13. Centers for Disease Control and Prevention. Reported Tuberculosis in the United States, 2020; Table 5. Tuberculosis Cases, Percentages, and Incidence Rates per 100,000 Population by Origin of Birth: United States, 1993–2020. Accessed October 18, 2022. https://www.cdc.gov/tb/statistics/reports/2020/table5.htm
14. Centers for Disease Control and Prevention. Who Should Be Tested for TB Infection. Accessed October 18, 2022. https://www.cdc.gov/tb/topic/testing/whobetested.htm
15. Centers for Disease Control and Prevention. Reported Tuberculosis in the United States, 2020; Table 6A. Tuberculosis Cases and Percentages Among Non-U.S.–Born Persons by the Top 30 Countries of Birth: United States, 2016–2020. Accessed October 18, 2022. https://www.cdc.gov/tb/statistics/reports/2020/table6A.htm
16. Geng E, Kreiswirth B, Driver C, et al. Changes in the transmission of tuberculosis in New York City from 1990 to 1999. N Engl J Med. 2002;346(19):1453-1458.
17. Chin DP, DeRiemer K, Small PM, et al. Differences in contributing factors to tuberculosis incidence in U.S.-born and foreign-born persons. Am J Respir Crit Care Med. 1998;158(6):1797-1803.
18. Talbot EA, Moore M, McCray E, Binkin NJ. Tuberculosis among foreign-born persons in the United States, 1993-1998. JAMA. 2000;284(22):2894-2900.
19. Borgdorff MW, Behr MA, Nagelkerke NJ, Hopewell PC, Small PM. Transmission of tuberculosis in San Francisco and its association with immigration and ethnicity. Int J Tuberc Lung Dis. 2000;4(4):287-294.
20. Jasmer RM, Ponce de Leon A, Hopewell PC, et al. Tuberculosis in Mexican-born persons in San Francisco: reactivation, acquired infection and transmission. Int J Tuberc Lung Dis. 1997;1(6):536-541.
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24. Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. Accessed October 18, 2022. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf
25. Lewinsohn DM, Leonard MK, LoBue PA, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: diagnosis of tuberculosis in adults and children. Clin Infect Dis. 2017;64(2):e1-e33.
26. Kahwati LC, Feltner C, Halpern M, et al. Screening for Latent Tuberculosis Infection in Adults: An Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 142. Rockville, MD: Agency for Healthcare Research and Quality; 2016. AHRQ Publication No. 14-05212-EF-1.
27.Yang H, Kruh-Garcia NA, Dobos KM. Purified protein derivatives of tuberculin--past, present, and future. FEMS Immunol Med Microbiol. 2012;66(3):273-280.
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29. US Preventive Services Task Force. Screening for latent tuberculosis infection in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(9):962-969.
30. Thompson MJ. Efficacy of various durations of isoniazid preventive therapy for tuberculosis: five years of follow-up in the IUAT trial. International Union Against Tuberculosis Committee on Prophylaxis. Bull World Health Organ. 1982;60(4):555-564.
31. Menzies D, Long R, Trajman A, et al. Adverse events with 4 months of rifampin therapy or 9 months of isoniazid therapy for latent tuberculosis infection: a randomized trial. Ann Intern Med. 2008;149(10):689-697.
32. Menzies D, Adjobimey M, Ruslami R, et al. Four months of rifampin or nine months of isoniazid for latent tuberculosis in adults. N Engl J Med. 2018;379(5):440-453.
33. Sterling TR, Villarino ME, Borisov AS, et al. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011;365(23):2155-2166.
34. Sun HY, Huang YW, Huang WC, et al. Twelve-dose weekly rifapentine plus isoniazid for latent tuberculosis infection: a multicentre randomised controlled trial in Taiwan. Tuberculosis (Edinb). 2018;111:121-126.
35. Krebs A. The IUAT trial on isoniazid preventive treatment in persons with fibrotic lung lesions. Bull Int Union Tuberc. 1976;51(1):193-201.
36. Menzies D, Dion MJ, Rabinovitch B, Mannix S, Brassard P, Schwartzman K. Treatment completion and costs of a randomized trial of rifampin for 4 months versus isoniazid for 9 months. Am J Respir Crit Care Med. 2004;170(4):445-449.
37. White MC, Tulsky JP, Lee JR, et al. Isoniazid vs. rifampin for latent tuberculosis infection in jail inmates: toxicity and adherence. J Correct Health Care. 2012;18(2):131-142.
38. Sterling TR, Moro RN, Borisov AS, et al. Flu-like and other systemic drug reactions among persons receiving weekly rifapentine plus isoniazid or daily isoniazid for treatment of latent tuberculosis infection in the PREVENT Tuberculosis Study. Clin Infect Dis. 2015;61(4):527-535.
39. Taylor Z, Nolan CM, Blumberg HM. Controlling tuberculosis in the United States. Recommendations from the American Thoracic Society, CDC, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2005;54(Rr-12):1-81.
40. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care. 8th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2017.
41. American Academy of Family Physicians. Clinical Practice Guideline: Tuberculosis Infection, Asymptomatic Adults. Accessed October 18, 2022. https://www.aafp.org/family-physician/patient-care/clinical-recommendations/all-clinical-recommendations/tuberculosis.html
|Detection||The USPSTF found adequate evidence that the tuberculin skin test and interferon-gamma release assay are accurate screening tests to detect LTBI.|
|Benefits of Early Detection and Intervention and Treatment||
|Harms of Early Detection and Intervention and Treatment||
|USPSTF Assessment||The USPSTF concludes with moderate certainty that there is moderate net benefit in preventing progression to active tuberculosis disease by screening for LTBI in persons at increased risk for tuberculosis infection.|
Abbreviations: CDC=Centers for Disease Control and Prevention; LTBI=latent tuberculosis infection; USPSTF=U.S. Preventive Services Task Force.