In addition, in the patient who underwent serial QFT, there was a correction of both mitogen and TB antigen responses between TB diagnosis and 5 weeks later under treatment. Clinicians should take notice of the mitogen response since IFN- concentrations lower than <2 IU/ml were associated with false-negative QFT results in tuberculosis patients, independently associated with ongoing infections, and could be associated with worse prognosis. As with most medical processes, the QuantiFERON TB Gold test has its pros and cons. . 0000024723 00000 n A total of 872 patients were included. QuantiFERON; infection; mitogen; mortality; outcomes. }jW!)Z.,-A7Oe5yaWz>o` ro|:V_TnP1 \:{>X P3Zfq\M[6i[BHy.Nr["na'$7Q&vM:g4!&k;dHqYso=KJgK0.}vU Szenzitizlt egynek friss heparinizlt teljes vr mintjban tuberkulzis antignek hatsra T sejtekbl gamma interferon szabadul fel. QuantiFERON-TB Gold Plus, 1 Tube - This test is a blood-based interferon-gamma release assay (IGRA) used as an aid in the diagnosis of Mycobacterium tuberculosis infection. These values do not apply to results that are converted to other units of measure. The TB antigen and mitogen results of the QFT-GIT test and lymphocyte counts for the cases sub-divided into different co-morbid conditions are illustrated in Table 4. above the Nil IFN- IU . They can be sent to you directly, or to your school or workplace. It decreased again in the U.S. in 1993 but is still a concern as tuberculosis cases can re-emerge. 19. Even when it isn't fatal, tuberculosis can cause a lung infection, spread to the kidneys, and even affect the brain. Blood samples are mixed with antigens (substances that can produce an immune response) and controls. QFT results indicative of M. tuberculosis infection include the following three criteria: (mitogen -- nil) and (tuberculin -- nil) are both >1.5 IU; and We thank the patients, Jean-Baptiste Bour (for his invaluable help in conducting this study) and the technicians from the virology laboratory, Maud Carpentier from the DRCI (Direction de la Recherche Clinique et de lInnovation), Emmanuel Florentin for the extraction of biological data, Aurlie Bertaut, Olivera Buirey and Julie Gentil from the CGFL, and Suzanne Rankin for proofreading and editing the manuscript. In our study, 8% of hospitalized patients had indeterminate QFT results, which is in the range of other previously published studies (5). An official website of the United States government. Factors related to COVID-19 severity, such as higher lactate dehydrogenase (LDH) (odds ratio [OR] 1.005 [95% condence interval [CI] 1.002-1.008]) and previous administration of corticosteroids (OR 4.477 [95% CI 1.397-14.345]), were independent predictors for indeterminate QFT-Plus assay. 24. Proportion of patients with infectious complications during hospital stay after QFT sampling (A), intensive care unit (ICU) admissions (B), in-hospital mortality (C) and the median (interquartile range) hospital length of stay (D) were recorded and represented according to the mitogen response: negative (IFN- 0.5 IU/ml), weak (IFN- = 0.52 IU/ml) and normal (IFN- > 2 IU/ml). [4][5] However, one of the five sites involved in the CDC study reported less agreement. 0000001056 00000 n QuantiFERON TB1 Ag Value 0.02 IU/mL 01 QuantiFERON TB2 Ag Value 0.02 IU/mL 01 QuantiFERON Nil Value 0.02 IU/mL 01 QuantiFERON Mitogen Value 0.10 IU/mL 01 QuantiFERON-TB Gold Plus NOTE [A] 01 NOTE: Indeterminate NOT Intermediate Reference Range: Negative 20 . Quantiferon-TB Gold Plus (8000101014) Test Mnemonic: QUANTIFERON-TB ASSAY. Divangahi M, Aaby P, Khader SA, Barreiro LB, Bekkering S, Chavakis T, et al. Indeterminate due to Low Mitogen Value: Indeterminate due to a low IFN-gamma level in the mitogen (positive control) tube. Eur Respir J. (2018) 31:e2118. [12][13], Limitations of QFT include the need to draw blood and process it within 16 hours after collection and limited laboratory and clinical experience with the assay. QFT result by category Total number tested Incident TB (324 months) . We then addressed the problem of the cut-offs for mitogen positivity. Frequency and significance of indeterminate and borderline Quantiferon Gold TB IGRA results. 0000004397 00000 n Epub 2019 Oct 3. It is generally recommended to results where Nil > 8.0 IU/ml (high background) consider . Identifying the situations that are associated with negative QFT performance could avoid unnecessary costs and diagnostic delay. doi: 10.1128/CMR.00021-18, PubMed Abstract | CrossRef Full Text | Google Scholar, 2. Is not subject to reader bias that can occur with TST. Significance of the TB Antigen Results : QuantiFERON-TB Gold Plus (QFT-Plus) is a 4th generation in vitro diagnostic test using a peptide cocktail with ESAT-6 and CFP-10 proteins to stimulate cells, particularly . Tuberculin skin testing (TST) has been used for years as an aid in diagnosing latent tuberculosis infection (LTBI) and includes measurement of the delayed type hypersensitivity response 4872 hours after intradermal injection of PPD. TB testing is normally mandated for students, healthcare workers, international travelers, those taking immigration medical exams, and others who may be vulnerable. quantiferon mitogen value normal range. Introduction: As such, the CDC has advised that the QuantiFERON test be done either on the same day that the live vaccine is administered or a minimum of four weeks after. QFN Control BCT workflow includes . Errors in collecting or transporting blood specimens or in running and interpreting the assay can decrease the accuracy of QFT-G. . Quantiferon-TB Gold In-Tube Test (10010388) Test Mnemonic: QUANTIFERON-TB GOLD. Mitogen minus Nil [IU/mL] QuantiFERON-TB Plus Result Reporting; 8.0: 0.35 and 25% of Nil value: Any: Any: Positive: POC: Any: 0.35 and 25% of Nil value: POC . Frequency and significance of indeterminate and borderline Quantiferon Gold TB IGRA results. J Pediatr Gastroenterol Nutrit. For example, coughing up mucus or blood may point to TB infection in the lungs, and experiencing bone pain might mean that it has infected the bones. However, longitudinal studies have shown that a significant number of test reversions and conversions occur if results just above or . TST and QFT do not measure the same components of the immunologic response and are not interchangeable. Eur Respir J. Decreasing mitogen response (normal, weak and negative, respectively) was associated with increasing length of hospital stay [median (interquartile range) 5 (3-13), 11 (5-21) and 15 (10-30) days; p < 0.001] and increasing hospital mortality (3, 7, and 15%; p < 0.001). Posted in:homes for sale riverfront suffolk, va. Posted by: industrial revolution symbols . NV 11 0 obj <> endobj Before 0000017743 00000 n This is because everyone's immune systems are different. Results: A total of 872 patients were included. Ferrara G, Losi M, Meacci M, Meccugni B, Piro R, Roversi P, et al. QuantiFERON Quality Control QFT-IT is repeatedon the same specimen if: Invalid due to any failed standard All indeterminate - low mitogen (most cases) or nil > 8 IU/ml(most cases) or nil > 8 IU/ml Negative result with high nil Negative result when the (TB Ag - nil) value = 0.25 to 0.35 All positive results Our case-control study involving 872 hospitalized patients who underwent QFT testing yielded four main results. 71775-1. Analyses were performed using Stata v15.1 (StataCorp LLC, College Station, TX, United States) and GraphPad Prism software version 9.1.1 (San Diego, CA, United States). The QuantiFERON-TB Gold blood test takes some of the guesswork out of the tuberculosis screening process. When considering only clinical variables, multivariable analysis revealed that an ongoing infection at the time of QFT was independently associated with both a negative (negative vs. normal RR = 4.34; 95% CI = 2.946.41), and a weak mitogen response (weak vs. normal RR = 2.44; 95% CI = 1.663.58), as well as older age and immunodepression. Written informed consent for participation was not required for this study in accordance with the national legislation and the institutional requirements. QFT was less frequently positive if mitogen response was weak (25% of cases) compared to normal (80% of cases). 1. A low response to mitogen (<0.5 IU/mL) indicates an Indeterminate result when a blood sample also has a eCollection 2022. [15] This test was approved by the U.S. Food and Drug Administration (FDA) in 2005. 0000002253 00000 n Indeterminate results may relate to the immune status of the individual being tested, or may be . One could assume that decrease in both lymphocyte activation and systemic inflammation (reflected by CRP levels) would improve lymphocyte function. Casenaz A, Grosjean S, Aho-Gll LS, Bour JB, Auvray C, Manoha C. Front Med (Lausanne). Low values can occur due to sample handling errors that adversely impact lymphocyte activity/viability, low lymphocyte counts, and other factors that decrease cell mediated immune responses. The clinical and biological characteristics of the three groups are compared in Table 1. Boomer JS, Shuherk-Shaffer J, Hotchkiss RS, Green JM. This test was approved by the U.S. Food and Drug Administration (FDA) in 2005. The updated guidelines provide new direction for TB control in the US. Storage/Transport: Maintain tubes at room temperature (22C 5C). While most of the identified factors are related to chronic conditions, little attention has been paid to the factors potentially associated with acute conditions at the time of QFT sampling. 4. LOINC code 71774-4 Mitogen stimulated gamma interferon [Units/volume] . These results offer new insight about QFT performance, particularly during TB, which is associated with both systemic inflammation and T-cell exhaustion. In order to provide a better understanding of indeterminate QFT, our aim was to assess the factors associated with mitogen response, including ongoing or recent infection. Huang C-T, Lee M-R, Ruan S-Y, Tsai Y-J, Wang J-Y, Yu C-J. Specimen Requirements: . In addition, male sex, diabetes, and an infection within 3 months before QFT were independently associated with a negative mitogen response, but not with a weak mitogen response, as compared with a normal response (Model 1, Table 2). -. Requires a single patient visit to draw a blood sample. government site. Detection of interferon-y by enzyme-linked immunosorbent assay (elisa) is used to identify in vitro responses to these peptide antigens that are associated with mycobacterium tuberculosis infection. Let's dive into the pros and cons and result interpretations of the QuantiFERON TB Gold test, as well as more information on tuberculosis. See this image and copyright information in PMC. Decreasing mitogen response (normal, weak and negative, respectively) was associated with increasing length of hospital stay [median (interquartile range) 5 (313), 11 (521) and 15 (1030) days; p < 0.001] and increasing hospital mortality (3, 7, and 15%; p < 0.001). 0000012959 00000 n This value is subtracted from the TB1, TB2 and the Mitogen tests. It spreads from one person to another via tiny water droplets which are excreted into the air when an infected person coughs or sneezes. As compared to the normal mitogen response group, the negative response group were significantly more likely to have had surgery and an infection, or a severe infection within the 3 months preceding the QFT, and those with a weak response were significantly more likely to have had a severe infection in the 3 months preceding the QFT. . The QuantiFERON -TB Gold IT system uses specialized blood collection tubes, which are used to collect whole blood via venipuncture, which include a Nil control tube, TB Antigen tube and a Mitogen tube (positive control). A mitogen is a small bioactive protein or peptide that induces a cell to begin cell division, or enhances the rate of division (). Is not affected by prior BCG (bacille Calmette-Gurin) vaccination. Components Reference Interval; QuantiFERON-TB Gold In-Tube: . Comparison of two commercial interferon-gamma assays for diagnosing Mycobacterium tuberculosis infection. We can assume that confirmed TB cases with extensive diseases and/or those with systemic involvement were associated with both systemic inflammation and T-cell exhaustion. May 10, 2022 9:876864. doi: 10.3389/fmed.2022.876864. In addition, the clinical relevance of the standard 0.5 IU/mL threshold is a matter of debate, and it has been suggested that a response to PHA with IFN- < 10 IU/mL could be considered possibly altered rather than normal (18). Front Immunol. 23. MJ, MB, and CB: drafting of the manuscript. The results are valid for all cases that would normally need a TB skin test. Elevated Nil values greater than 8.0 IU/mL will produce a test interpretation of Indeterminate. Normal range/expected value(s) for a specific disease state. J Crohns Colitis. 0000000016 00000 n S+8)Z" 0lSO#ImlvK=Iv'|)Gqgr_Q(n;u*qoqR%e%:Q{vIV*p^(6/QZ aLK\;kWvJku_#saD A"r'ZsB*J S+$7J*}y&Zk(+thF~S[ih(!6! Extremes of age are associated with indeterminate QuantiFERON-TB gold assay results. You must tell your doctor what medicine you are taking, your medical history and if you are pregnant or breastfeeding. Mitogen - Nil: High, usually >10.0: This is a measure of the cell's ability to produce gamma interferon in response to non-specific mitogen stimulation. Although the numbers were small, all of the close contacts who went on to develop active TB were QFT positive, but only 83% were TST positive. Moreover, QFT-Plus is now optimized with innovative CD8 T cell technology, providing a more comprehensive view of . Pourakbari B, Mamishi S, Benvari S, Mahmoudi S. Adv Med Sci. Accessibility On 25 June 2010, the US Centers for Disease Control and Prevention (CDC) updated the tuberculosis (TB) testing guidelines providing guidance to US public health officials, clinicians, and laboratory workers regarding screening for and diagnosis of TB infection. what is a normal mitogen level; change page title html. [6] Although there have been studies confirming the increased future risk of active TB in individuals with positive TST, the same was not true for those with a positive IGRA result. M. tuberculosis complex infection unlikely. The median values of three mitogens were in the following order: PWMCon A positive control>>PHA-P>>negative control. According to the World Health Organization, it caused approximately 1.5 million deaths in 2020. NIL 0.07 IU/mL KS MITOGEN-NIL >10.00 IU/mL KS TB-NIL 0.00 IU/mL KS The Nil tube value is used to determine if the patient has a preexisting immune response which could cause a Knock out the normal WRNMMC - screen new hires, varies between Two Step Testing and IGRA . The mitogen tube must demonstrate an interferon- value of 0.5 IU/ml higher than the value of the NIL tube. May also include abnormal ranges. trailer The gray section represents the IFN- values ranging in 0.2-0.7 IU/mL the so called "uncertainty zone". 71775-1. After the blood sample is taken and analyzed, the QuantiFERON TB Gold test will render one of the following results: Negative or Normal. Unable to load your collection due to an error, Unable to load your delegates due to an error, Inverse correlation between INF- mitogen response and C-reactive protein levels in hospitalized patients. Sample results. 89123, Email: Proportion of patients with infectious complications during hospital stay after QFT sampling. However, interestingly, we found that both recent and ongoing infection were independent factors associated with a negative mitogen response. Also referred to as inactive TB or a TB infection, this type of tuberculosis is not contagious. Patients who receive a positive test result should be evaluated by a medical professional to see if they are likely to progress to active TB. Guignant C, Lepape A, Huang X, Kherouf H, Denis L, Poitevin F, et al. Clinical outcomes (onset of an acute infection, sepsis or septic shock after QFT sampling, ICU admission, in-hospital mortality and hospital length of stay) were also recorded. Among tuberculosis patients, a weak mitogen response was associated with a false-negative QFT result (75%) compared to a normal response (20%). I fly out of the county alot and e7Health is always flying with me! Persistent lymphopenia after diagnosis of sepsis predicts mortality. NB: IFN-, interferon , QFT, QuantiFERON-TB Gold. Prognostic value of the mitogen response in the interferon- release assay in patients with culture-confirmed tuberculosis. J Transl Med. National Library of Medicine These values do not apply to results that are converted to other units of measure. - by How it could be impacted and associated with outcomes is poorly known. n tested. (2011) 15:R99. 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