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Use of the tuberculin skin test for diagnosis of tuberculosis infection (tuberculosis screening) in adults

Use of the tuberculin skin test for diagnosis of tuberculosis infection (tuberculosis screening) in adults
Literature review current through: Jan 2024.
This topic last updated: Jun 01, 2023.

INTRODUCTION — Identification and treatment of individuals with tuberculosis (TB) infection is an important priority for TB control. The approach to diagnosis of TB infection is discussed separately. (See "Tuberculosis infection (latent tuberculosis) in adults: Approach to diagnosis (screening)".)

TB infection is a clinical diagnosis that is established by demonstrating prior TB infection and excluding TB disease [1-4]. Available tests to demonstrate prior TB infection include the tuberculin skin test (TST) and interferon-gamma release assays (IGRAs). These measure immune sensitization (type IV or delayed-type hypersensitivity) to mycobacterial protein antigens that might occur following exposure to (and infection by) mycobacteria (table 1).

There is no clear advantage of the IGRA or the TST for predicting future risk of TB disease; the decision to select a test should be based on the setting, cost, and availability. Issues related to use and interpretation of the TST are reviewed here; issues related to interpretation of IGRAs are discussed separately. (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults".)

TERMINOLOGY — TB terminology is inconsistent in the literature [5]. Relevant terms are defined in the table (table 2).

PERFORMING THE TST

General principles — The TST consists of intradermal injection of tuberculin material, which stimulates a delayed-type hypersensitivity response mediated by T lymphocytes and, in patients with prior mycobacterial exposure, causes induration at the injection site within 48 to 72 hours.

In the United States, two US Food and Drug Administration (FDA)-approved purified protein derivative (PPD) tuberculin antigens are available in the United States for use in performing TSTs: Tubersol and Aplisol.

Tuberculin skin testing is performed via the Mantoux technique, which consists of intradermal injection of tuberculin material on the inner surface of the forearm [6,7]. Epinephrine should be available during TST placement. (See 'Adverse reactions' below.)

To read the test, the transverse diameter of the induration (not erythema) should be demarcated, measured, and recorded in millimeters. The test should be read 48 to 72 hours following intradermal injection. The results are less reliable if the test is read after 72 hours. A strongly positive reaction after 96 hours may be accepted; however, results become increasingly doubtful with longer intervals between injection and reading. In one study including 400 individuals with positive TST at 48 to 72 hours, about 20 percent had negative results when the TST was read seven days after placement [8].

If the TST cannot be read within 48 to 72 hours, repeat testing should be performed. If a new TST is performed ≥7 days after the unread test, then boosting may cause a positive TST result on the second test (see 'Serial testing' below). However, in the absence of a documented negative first TST, there is no way to know if the second TST represents boosting or new infection. Hence, the second TST must be interpreted in the same way as a single initial TST. This potential problem reinforces the importance of reading the TST at the correct time.

Multipuncture methods (including the Tine test and the Heaf test) should not be used; they may be easier to administer but are not accurate because it is not possible to precisely control the amount of tuberculin [6].

The TST may be repeated with no effect on subsequent testing. Administration of one or more TSTs does not stimulate type IV hypersensitivity to tuberculin (ie, repeated testing does not sensitize individuals to the test reagent) [7].

Tuberculin skin testing materials — In North America, the tuberculin material used is termed PPD (from purified protein derivative); the standard dose is 5 tuberculin units (0.1 mL). In the United States, two US Food and Drug Administration (FDA)-approved PPD materials are available for use in performing TSTs: Tubersol and Aplisol. In other regions of the world, RT-23 may be the tuberculin material used; the standard dose is 2 tuberculin units. These doses have been shown to be equivalent [9].

Tuberculosis antigen-based skin tests (TBST) are skin tests which use the same proteins employed by IGRAs (ESAT6 and CFP10); TBST were endorsed by the World Health Organization (WHO) in 2022 [3]. These tests have been shown to have similar sensitivity and specificity as commercial IGRAs [10]; thus far they are not available in the United States.

Importance of quality assurance — For optimal accuracy, the TST should be administered and interpreted by health care professionals who are properly trained and participate in a quality assurance program to maintain skills; however, there are no training requirements or quality assurance programs for TST. Training resources are available [11], including online training and quality assurance procedures [12].

In low-TB incidence areas, maintenance of skills in administration and reading of TST may be difficult. In the absence of available tools to maintain these skills, we favor use of IGRAs, since the laboratories performing these tests must demonstrate adequate training and quality assurance for certification. (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults".)

Adverse reactions — In general, adverse reactions to TST are rare; the most important is hypersensitivity to the tuberculin skin test materials (<1 per million). Manifestations may include urticaria, dyspnea, and angioedema [13]. These manifestations occur immediately (within 15 minutes) or within 6 to 12 hours. Adverse reactions should not be confused with or interpreted as a positive TST. In addition, secondary bacterial infection may develop at an exuberant test reaction site.

INTERPRETING THE TST

General principles — The TST reading must establish a positive or negative result in order to determine subsequent management; size cut-off for TST positivity differs by risk strata (figure 1 and table 3). An online TST/interferon-gamma release assay (IGRA) algorithm has been developed to facilitate the interpretation of these tests [14]. The algorithm provides information on positive predictive value of a test result along with predicted risk of progression to disease.

Sensitivity of TST for the 5 mm, 10 mm, and 15 mm threshold is 98, 90, and 50 to 60 percent, respectively [15]. As the cutoff for mm of induration increases, the sensitivity decreases and the specificity increases. A higher cutoff is useful for evaluation of individuals in regions with low rates of true TB infection. Guidelines in the United Kingdom for TST interpretation are discussed separately. (See "Tuberculosis infection (latent tuberculosis) in adults: Approach to diagnosis (screening)", section on 'United Kingdom'.)

If the TST is negative, the possibility of a false-negative result must be considered, as discussed in the following section. Repeat testing is warranted in the circumstances outlined above. (See 'Repeat and serial testing' below.)

If the TST is positive, no further testing is warranted. The patient should be referred for medical evaluation to exclude TB disease, followed by consideration for initiation of treatment for TB infection. (See 'Positive tests' below.)

Negative tests

Causes of false-negative tests — False-negative TST results may occur in the setting of biologic and technical limitations (table 4). Biologic limitations include immunosuppression, natural waning of immunity, or very recent infection. Technical limitations include improper tuberculin handling and interpretation. Among HIV-infected patients, the reactivity of TST and IGRA appear comparable [16].

Measles vaccination may temporarily suppress tuberculin reactivity. Measles-mumps-rubella (MMR) vaccine may be given after, or on the same day as, the TST. If MMR has been given recently, TST should be postponed until four to six weeks after administration of MMR [17].

Anergy testing with control antigens such as mumps and Candida was previously thought to help determine between true-negative and false-negative tuberculin tests. However, the role of anergy testing in the diagnosis of TB infection is not well defined, and such testing is not recommended [4-7,9].

Management of individuals with negative test — In the setting of recent close contact to individuals known to have infectious TB, treatment for TB infection should be considered for adults who are severely immunocompromised (such as HIV infected or organ transplant recipient), even with negative TST or IGRA.

For these patients, TB infection therapy should be initiated (following clinical evaluation to rule out TB disease) and the TST or IGRA repeated after eight weeks [18]. If the second test is positive, treatment should be continued; if the second test is negative, treatment is usually stopped, although continued therapy may be considered on an individual basis, based on degree of immunosuppression and assessment of individual risk.

The approach to treatment is discussed in detail separately. (See "Treatment of tuberculosis infection (latent tuberculosis) in nonpregnant adults without HIV infection".)

Positive tests — The positive predictive value (PPV) denotes the probability of true infection in the setting of a positive test. The greater the risk of exposure (due to risk factors such as close contact with an TB disease case or prior residence in a high-incidence country), the higher the PPV. A computer-based algorithm is available to assist in the interpretation of TST.

Causes of false-positive tests — Causes of false-positive TST include nontuberculous mycobacteria infection and Bacillus Calmette-Guérin (BCG) vaccination. Among individuals with high likelihood of TB infection and/or high risk of development of disease if infected, potential causes of false-positive tests should not influence the decision to administer TB infection therapy.

Nontuberculous mycobacteria – Infection with nontuberculous mycobacteria (NTM) may cause false-positive reactions to tuberculin. Estimates of the frequency of false-positive TSTs due to NTM range from 1 to 5 percent of positive tuberculin tests [19] to as many as 50 percent of 9 to 14 mm reactions in United States health care workers (HCWs) [19,20]. Therefore, the effect is important only if the prevalence of true TB infection is low (ie, less than 5 percent) and the prevalence of sensitivity to NTM antigens is high; this situation occurs in low-incidence countries with tropical, subtropical, or temperate climates such as the southern United States [14,19].

BCG vaccination – BCG vaccination is a well-known but frequently misunderstood cause of false-positive tuberculin reactions. The effect of BCG on TST depends primarily on the age of BCG vaccination [19]. BCG vaccination in the first year of life may produce low-level TST reactivity in adults; such reactions are typically <10 mm and rarely persist past the age of 10 years. Vaccination after the first year of life (such as at entrance to primary school at age 5 to 6) may cause a stronger and longer-lasting effect on TST; as many as 20 percent of individuals remain TST positive 10 years or more after vaccination at this age [21]. In pediatric populations, the interval since vaccination is important since there is progressive waning during the first 10 years after vaccination.

New TST materials using the same antigens as in the IGRA tests (ie, ESAT6 and CFP10) have been developed. In preliminary studies these assays appear to have similar sensitivity and specificity as IGRAs [10,22,23]; thus far, these tests are not available for routine use.

Current and past BCG vaccination policies for most countries of the world may be reviewed online at the World Atlas of BCG Policies and Practices [24]. Most persons with a history of childhood BCG immunization have a lasting vaccine scar (typically over the deltoid; in some countries, BCG scars may appear on the forearm or upper outer thigh) (picture 1).

TST reactivity caused by BCG sensitization can be distinguished from TB infection by IGRAs. (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults".)

Management of individuals with positive test — Patients with positive TST must undergo clinical evaluation to rule out TB disease prior to treatment for TB infection. (See "Tuberculosis infection (latent tuberculosis) in adults: Approach to diagnosis (screening)", section on 'Excluding TB disease'.)

The approach to treatment of TB infection is discussed in detail separately. (See "Treatment of tuberculosis infection (latent tuberculosis) in nonpregnant adults without HIV infection".)

Health care workers — Indications for TB infection testing in HCWs are discussed separately [25]. (See "Tuberculosis infection (latent tuberculosis) in adults: Approach to diagnosis (screening)", section on 'Health care workers in some settings'.)

Issues related to interpreting serial TST results are discussed below. (See 'Repeat and serial testing' below.)

In the setting of a recognized exposure, HCWs with a baseline negative TB test and no prior TB disease or TB infection should undergo testing (IGRA or TST) when the exposure is identified; if that test is negative, another test should be performed 8 to 10 weeks after the last exposure [25]. If TST is used for the initial test, it may be impossible to distinguish new infection from boosting on the second test, especially if baseline negative testing was recorded many years before the initial TST (see 'General principles' above). Alternatively, one test may be performed 8 to 10 weeks following the end of exposure.

In general, if primary TB infection develops following clinical exposure, TST conversion occurs three to eight weeks later [18]. For HCWs with a baseline TST of 0 mm, TST ≥5 mm is considered a positive result; for HCWs with a baseline TST result >0 mm but <10 mm, TST ≥10 mm is considered a positive result [26].

The role of interferon-gamma release assay for serial testing in HCWs is uncertain; further study is needed. This issue is discussed further separately. (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults", section on 'Reproducibility'.)

Allergic reactions — Early reaction within 24 hours with absence of induration at 48 to 72 hours is considered an allergic reaction [27]. Immediate hypersensitivity skin reactions to the TST are possible; these consist of wheal and flare response at the testing site within 20 minutes of purified protein derivative (PPD) placement. In a case series of 3248 allergy clinic patients, immediate hypersensitivity to skin testing with PPD was observed in 2 to 3 percent of patients, without systemic reactions [27]. Systemic allergic reactions (including urticaria, angioedema, dyspnea, and anaphylaxis) are rarely reported [13,28]. The incidence is estimated to be 1 to 3 per million distributed doses, which is similar to the rate of anaphylaxis with vaccines [13]. (See "Allergic reactions to vaccines".)

In our experience, a diffuse maculopapular rash can appear within 12 hours and resolve within a day or two, although such allergic reactions to the TST are relatively uncommon. The incidence of these reactions in our clinic is in the range of 1 reaction per 2000 to 3000 patients [29]. These allergic reactions are unrelated to the TST result at 48 to 72 hours.

Patients with immediate skin test reactions or other types of allergic reactions to the TST should not receive the TST again. An IGRA should be performed instead. If serial testing is required, IGRA may be used; however, there are a number of challenges associated with the use of IGRAs for serial testing. In such cases, we assess such individuals annually for symptoms of TB disease and obtain a chest radiograph if new symptoms develop. (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults", section on 'Serial testing, conversion, and reversion'.)

REPEAT AND SERIAL TESTING

General principles — If the TST is documented to be positive, it should never be repeated. Once the TST is positive it will remain positive, and repeating the test has no clinical utility. However, if there is a history of a positive TST but this is not documented, then it may be appropriate to confirm this.

Individuals who were immunocompromised when they underwent TST or IGRA may have false-negative test results. If the immunocompromising condition is treated (eg, HIV-infected person who receives antiretroviral therapy) or eliminated (eg, immunocompromising medication such as prednisone is stopped), then testing may be repeated.

For individuals with history of a positive TST or IGRA, there are no additional mechanisms to evaluate for subsequent TB exposure. For individuals with history of TB infection (ie, with a documented positive TST or IGRA with clinical and radiographic evaluation to exclude TB disease), baseline chest radiography (at the discretion of the clinician) may be useful, whether or not treatment for TB infection was completed. If symptoms suggestive of TB disease develop, repeat chest radiograph and microbiologic investigations should be pursued. (See "Diagnosis of pulmonary tuberculosis in adults".)

Repeat testing — If the initial TST is negative, repeat TST is warranted for close contacts of patients with untreated pulmonary TB disease (algorithm 1). These individuals may have an initial negative TST because the TB infection was so recent that delayed hypersensitivity has not yet developed. In these individuals, the TST should be repeated eight to ten weeks after the last exposure, since it usually takes three to eight weeks for tuberculin conversion to occur after new infection [18]. The same technique and dose are used, but the TST is applied on the opposite forearm.

In the setting of recent exposure, we define skin test conversion if the induration of the repeat TST measures ≥10 mm and has increased by ≥6 mm over the previous test (ie, the initial negative TST). (See 'TST interpretation' below.)

Serial testing — Serial testing is warranted for individuals with ongoing potential exposure (algorithm 2). This may include residents or employees of homeless shelters or correctional facilities, and health care workers (HCWs) in a few circumstances [25]. Issues related to serial testing for HCWs are discussed separately [25]. (See "Tuberculosis infection (latent tuberculosis) in adults: Approach to diagnosis (screening)", section on 'Health care workers in some settings'.)

In settings where TB incidence is very low (less than 1 per 1000 per year), serial testing is not warranted for individuals other than those with occupational risk. In areas where TB incidence and the annual risk of infection are high, routine serial testing is usually not performed because of limited resources in these settings [30].

Prior to beginning serial tuberculin testing, two-step tuberculin testing should be performed to establish a correct baseline. In individuals with remote exposure to mycobacterial antigens (eg, due to prior BCG vaccination, nontuberculous mycobacteria infection, or remote TB infection), the tuberculin reaction may have waned due to reduction in number of sensitized T lymphocytes in the absence of new antigen exposure (faded immune memory), and an initial TST may be negative [31-33]. However, placement of the initial TST stimulates anamnestic recall of immunity, such that a second tuberculin test ("booster") will be positive. For this reason, evaluation for the "booster phenomenon" should be performed by repeating the TST (on the opposite forearm) one to four weeks after the initial test. The induration observed with the second test is the baseline that should be used for subsequent evaluation of skin test conversion. The risk of developing TB disease among individuals with a booster response is lower than the risk of developing TB disease among individuals with an initial positive TST [34,35]. Repeated administration of the TST in the absence of mycobacterial exposure or infection is not associated with a booster effect.

In the setting of serial testing in individuals with ongoing risk of exposure, skin test conversion refers to a positive TST after a baseline negative TST. The risk of developing TB disease is much higher in the setting of TST conversion than booster response. (See 'TST interpretation' below.)

The role of interferon-gamma release assay (IGRA) for serial testing in HCWs is uncertain, in large part due to high rates of false conversions in most studies in HCWs undergoing serial testing with IGRA. This issue is discussed further separately. (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults", section on 'Reproducibility'.)

TST interpretation — For TST conversion, we define the repeat TST as positive if the induration measures ≥10 mm and has increased by ≥6 mm since the previous test [4,18]. This definition is used because test variability may be associated with increases in induration of up to 6 mm. The definition of TST conversion used by United States Centers for Disease Control and Prevention (an increase in induration of ≥10 mm since the previous test) is more specific but less sensitive [4].

Issues related to TST interpretation for HCWs are discussed separately [25]. (See "Tuberculosis infection (latent tuberculosis) in adults: Approach to diagnosis (screening)", section on 'Health care workers in some settings'.)

Criteria for boosting and conversion of 12 mm, 15 mm, or even 18 mm have been suggested; these may be more specific but are much less sensitive. Individuals with reactions of ≥10 mm should be referred for medical evaluation to exclude TB disease prior to initiation of treatment for TB infection. The reaction should be documented, and no further tuberculin testing should be done.

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Diagnosis and treatment of tuberculosis".)

INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.)

Beyond the Basics topic (see "Patient education: Tuberculosis (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

Tools for diagnosis of TB infection – TB infection is a clinical diagnosis that is established by demonstrating prior TB infection and excluding TB disease. Available tests to demonstrate prior TB infection include the tuberculin skin test (TST) and interferon-gamma release assays (IGRAs) (table 1). Issues related to use of IGRAs are discussed separately. (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults".)

Interpreting the TST – The TST assesses the intradermal delayed-type hypersensitivity response produced by administration of purified protein derivative (PPD) from Mycobacterium tuberculosis. The interpretation is outlined in the table (table 3). (See 'Interpreting the TST' above.)

Negative tests

False-negative tests – TST can be falsely negative because of biologic problems (such as immunosuppression) or because of technical problems with the TST administration, PPD material, or reading (table 4). The TST result can be false positive because of infection with nontuberculous mycobacteria or prior immunization with Bacillus Calmette-Guérin (BCG). (See "Use of interferon-gamma release assays for diagnosis of tuberculosis infection (tuberculosis screening) in adults" and 'Interpreting the TST' above.)

Management of individuals with negative test – For immunosuppressed individuals who have had recent close contact with known infectious cases of TB, treatment for TB infection may be started even if the initial TST is negative. In such cases, testing for TB infection should be repeated after eight weeks. If the second test is positive, treatment is continued; if the second test is negative, treatment is usually stopped. (See 'Management of individuals with negative test' above.)

Positive tests – Patients with positive TST or IGRA results must undergo clinical evaluation to rule out TB disease and to assess need for treatment of TB infection. This includes evaluation for symptoms (eg, fever, cough, weight loss), physical exam, and radiographic examination of the chest. (See 'Management of individuals with positive test' above.)

Repeat testing – A period of up to eight weeks after primary TB infection may be required for TST conversion to occur. Individuals with close contact to a known infectious case of TB and negative initial TST should have repeat TST 8 to 10 weeks after the end of exposure. (See 'Repeat testing' above.)

Serial testing – Serial testing is warranted for individuals with ongoing potential exposure. This includes residents or employees of homeless shelters or correctional facilities, and health care workers in some circumstances. In these settings, TST is the test of choice, given issues of false conversions and reproducibility with IGRAs. Those undergoing serial annual testing should also undergo testing after a known episode of exposure. (See 'Serial testing' above.)

ACKNOWLEDGMENT — The UpToDate editorial staff acknowledges Madhukar Pai, MD, PhD, who contributed to an earlier version of this topic review.

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References

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