Among tuberculosis patients, a weak mitogen response was associated with a false-negative QFT result (75%) compared to a normal response (20%). First, the retrospective design led to missing data, mainly for laboratory results. Keywords: A False Discovery Rate (FDR) was applied to account for multiple comparisons, and the results are expressed in Q-values. Clipboard, Search History, and several other advanced features are temporarily unavailable. No use, distribution or reproduction is permitted which does not comply with these terms. 0000016666 00000 n (2013) 67:288-93. doi: 10.1016/j.jinf.2013.06.005, 16. The gray section represents the IFN- values ranging in 0.2-0.7 IU/mL the so called "uncertainty zone". If performed in such a context, clinicians must interpret QFT with caution, especially if mitogen response if weak (IFN- = 0.52 IU/ml), whatever the official interpretation. NB: QFT, QuantiFERON-TB Gold; ICU, intensive care unit; IFN-, interferon . The QuantiFERON-TB Gold blood test takes some of the guesswork out of the tuberculosis screening process. [12], To its disadvantage, QFT can yield false positive results with Mycobacterium szulgai, Mycobacterium kansasii, and Mycobacterium marinum.[14]. TB is a severe illness with fatal consequences. QuantiFERON Mitogen minus NIL: 71774-4: 2006963: QuantiFERON NIL: 71776-9: 3000401: Quantiferon TB Gold Plus: 71773-6: 3000402: Quantiferon Plus TB1 minus NIL: 64084-7: QuantiFERON-TB Gold PLUS (4 tube assay). The nil tube value is subtracted from the values of the mitogen, TB1, and TB2 tubes for the final result of the respective tubes. The presence of an active infection within the last 3 months or at the time of the QFT sampling were recorded if the infection was clinically/biologically suspected or confirmed by the clinician in charge of the patient. . In this case, generally, the test must be retaken with a fresh blood sample. M:V> OEpfK|hsIBf="d"v0E?NEvyM/u;%O0N?kEa>(V::oU@ >r-4b9,#Dx!B-,DV$tSW};CS%3l& *h6XBf'K 9GD3&A=Z$OJik}^73DEqJZ[xS/B-nxo(t~U?$FBqj)/5"&H*ZLBEc~*}Ib It can be assumed that lymphopenia and T-cell exhaustion, which are frequent in TB (17), explain this lack of sensitivity in connection to an altered mitogen response. 0000002143 00000 n [15] This test was approved by the U.S. Food and Drug Administration (FDA) in 2005. 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). Two samples with indeterminate test results were due to high nil value (above 10 IU mL -1 ). Notice of Privacy Practices - This TB blood test is highly accurate, with sensitivity of 94% and specificity of 97%. Best. Lee JY, Choi HJ, Park I-N, Hong S-B, Oh Y-M, Lim C-M, et al. Test Result Name. (2017) 50:1701267. When the severe infection at the time of the QFT variable was added in the model instead of the an ongoing infection at the time of QFT variable (model 2), the first variable was independently associated with both a negative (RR = 20.09; 95% CI = 8.6946.46) and a weak (RR = 7.10; 95% CI = 2.9317.23) mitogen response (Supplementary Table 2). Kobashi Y, Sugiu T, Mouri K, Obase Y, Miyashita N, Oka M. Indeterminate results of QuantiFERON TB-2G test performed in routine clinical practice. In the context of culture-confirmed TB, QFT testing has been associated with negative sensitivity (70%) (26, 27). Am J Respir Crit Care Med. Average price range of the test is between Rs.2400 to Rs.5490 depending on the factors of city, quality and availablity. Objectives With the rapid expansion of the IGRA evidence-base in . More automation will be needed to accurately measure the QFT response. Primary site and microbial origin of the infection at the time of the QFT 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%). In the case of serially screened North American healthcare workers, QFT results just above this cutpoint produce false-positive test results that upon repeat testing revert to negative,[10] where tuberculosis screening is often mandated on an annual basis. Divangahi M, Aaby P, Khader SA, Barreiro LB, Bekkering S, Chavakis T, et al. (2010) 35:1179-82. Quantiferon-TB Gold In-Tube Test (10010388) Test Mnemonic: QUANTIFERON-TB GOLD. Royston P, Sauerbrei W. Building multivariable regression models with continuous covariates in clinical epidemiologywith an emphasis on fractional polynomials. Correlation between INF- mitogen response of QFT and C-reactive protein levels was assessed in hospitalized patients included in the study and with available C-reactive protein data (n = 825); Spearman test. 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. eCollection 2022. Patients under the age of 18, patients only admitted for consultation (as outpatients), those hospitalized for less than 48 h, and those with incomplete QFT results were not included (Figure 1). In a study of military personnel returning from missions, about one-half of the positive TSTs were falsely positive. The mitogen response (respectively normal, weak and negative) was associated with an increasing proportion of patient with onset of infectious complications (2, 5, 12%; p < 0.001), ICU admissions (3, 15, 32%; p < 0.001), hospital length of stay [median (interquartile range) = 5 (313); 11 (521) and 15 (1030) days; p < 0.001] and in-hospital mortality (3%, 7% and 15%; p < 0.001) (Figure 2 and Supplementary Table 6). Value. The mitogen tube must have a gamma interferon value 0.5 IU/mL higher than the value of the Nil tube, for the positive control and the test to be valid. endstream endobj 12 0 obj<> endobj 14 0 obj<> endobj 15 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 16 0 obj<> endobj 17 0 obj<> endobj 18 0 obj[/ICCBased 43 0 R] endobj 19 0 obj[/Separation/PANTONE#20327#20CVC 18 0 R 40 0 R] endobj 20 0 obj[/Separation/All 18 0 R 41 0 R] endobj 21 0 obj<> endobj 22 0 obj<>stream Assessment of the accuracy of these tests is limited by lack of a standard for confirming LTBI. J Crohns Colitis. what is the smallest header in html by default 0000025603 00000 n 24. The analysis for the first and second measurements across the full range of nil, mitogen, and TB responses showed mean differences of 0.1 IU/ml, 0.2 IU/ml, and 0.1 IU/ml, respectively. Components Reference Interval; QuantiFERON-TB Gold In-Tube: . After the blood sample is taken and analyzed, the QuantiFERON TB Gold test will render one of the following results: Negative or Normal. Programmed death-1 levels correlate with increased mortality, nosocomial infection and immune dysfunctions in septic shock patients. . doi: 10.1186/cc10112, 12. 0000002253 00000 n Indeterminate, which means that the test could not give a definitive negative or positive result. As noted above, prior BCG vaccination can produce false positive TST results. Cell Mediated Immune Response. In this study of immunocompetent recently exposed close contacts of active TB cases, the progression rate to active disease among untreated QFT positive individuals was significantly greater than for untreated TST positives (14.6% versus 2.3%). However, the association between infection and negative mitogen response among patients tested for a suspicion of LTI or tuberculosis (TB) has not yet been addressed. We defined two groups of cases with either negative [interferon (IFN)- 0.5 IU/ml, official threshold] or weak (0.52 IU/ml) mitogen response, and one group of controls with normal (>2 IU/ml) mitogen response. (2017) 43:133-41. doi: 10.1080/1040841X.2016.1185603, 18. Controls were defined as patients with a normal mitogen response IFN- > 2 IU/ml. The result of the test is a numeric value that relates to a continuous numeric scale. (2005) 44:561-71. Quantiferon TB minus NIL: result 0.40 H, ref ranges 0.00-0.35 IU/mL. previously reported that a lower mitogen response was associated with worse 1-year survival in TB patients (27). 0000008496 00000 n QFN Control BCT workflow includes . At first they tell you the civil physician only comes once a week and you After I received my shot I was kind of feeling nauseous. TB infections increased in 1985, partly due to the rise of HIV, which weakens the immune system and prevents it from eliminating the TB bacteria. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. HHS Vulnerability Disclosure, Help The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Neutrophil to lymphocyte count ratio as an early indicator of blood stream infection in the emergency department. QuantiFERON Mitogen minus NIL: 71774-4: 2006963: QuantiFERON NIL: 71776-9: 3000401: Quantiferon TB Gold Plus: 71773-6: 3000402: Quantiferon Plus TB1 minus NIL: 64084-7: Clinical outcomes of 872 hospitalized patients according to the mitogen response of QFT (negative, weak or normal). [4][5] However, one of the five sites involved in the CDC study reported less agreement. 3. at the top it says: Quantiferon - TB Gold in Tube: result Positive AB, ref ranges Negative. quantiferon mitogen minus nil normal range. Disadvantages and limitations of the test are: On 10/10/2007 the US FDA[19] gave approval for the Quantiferon TB Gold In Tube to be marketed in the US. Annu Rev Physiol. Limited data on the use of QFT-G to determine who is at risk for developing TB disease. We defined two groups of cases with either negative [interferon (IFN)- 0.5 IU/ml, official threshold] or weak (0.5-2 IU/ml) mitogen response, and one group of controls with normal (>2 IU/ml) mitogen response. They are surrogate markers of Mycobacterium tuberculosis infection and indicate a cellular immune response to M. tuberculosis if the latter is present. Please login . Clinical and biological data at the time of the QFT test were collected retrospectively. As with most medical processes, the QuantiFERON TB Gold test has its pros and cons. 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). Frequency and significance of indeterminate and borderline Quantiferon Gold TB IGRA results. 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. The negative and weak mitogen response groups were younger (p < 0.001 for both) than normal response group and less frequently immunocompromised (p < 0.001 for both). TEST INFORMATION: The Quantiferon-TB Gold (QFTB-G) is a test recommended for detection of the cellular immune response to infection with Mycobacterium tuberculosis, the agent that causes tuberculosis (TB). An individual is considered positive for M. tuberculosis infection if the IFN-gamma response to TB antigens is above the test cut-off (after subtracting the background IFN-gamma response in the negative control). TB testing is normally mandated for students, healthcare workers, international travelers, those taking immigration medical exams, and others who may be vulnerable. Ht[k7).XZS Table 2 . National Library of Medicine 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. Mitogen minus Nil (IU/ml) QFT -Plus Result Re sult interpretation 8.0 0.35 and 25% of Nil Any Any Positive M. tuberculosis infection likely Any 0.35 and 25% of Nil <0.35 or 0.35 and <25% of Nil <0.35 or 0.35 and <25% of Nil 0.50 Negative M. tuberculosis infection NOT likely <0.35 or 0.35 The results are typically released within three to five business days. [11], Previously, QuantiFERON-TB Gold was able to be used in any situation in which the Tuberculin Skin Test (TST) was used, without preference. QuantiFERON-TB Gold Plus: Results and Interpretation When it comes to result calculation, qualitative cutoff values, and result interpretation, the QFT-Plus is identical to the QFT-Gold assay, with the key exception that if either one or both of the QFT-Plus TB antigen tubes are equal to or greater than 0.35 IU/mL and are at least 25% of the . 2011;6(6):e20061. Blood samples must be processed within 16 hours after collection while white blood cells are still viable. The negative correlation we observed between C-reactive protein and mitogen response further supports this assumption. There were 252 (46.15%) negative, 219 (40.10%) positive and 75 (13.73%) indeterminate test results. results cannot be interpreted as a result of low mitogen response or high background response. Find a Test; New & Updated Tests; Test Resources; For Providers. It is generally recommended to results where Nil > 8.0 IU/ml (high background) consider . Am J Respir Crit Care Med. doi: 10.1186/cc11404, 15. xb```\V>k~e9~0_ :`u,2=|L@A4 h TR A h@ZU"J, 1-``(a\|s8\t]48,0gY~4`; hc *7 Interpretation of the QuantiFERON TB Gold Test Results. At the time of the QFT sampling, an ongoing infection was detected in, respectively, 18, 33, and 48% of patients with a normal, weak and a negative mitogen response, respectively, and septic shock was detected in 1, 4, and 11%, respectively. QuantiFERON Nil Value: IU/mL: 71776-9: Reflex Table for QuantiFERON Incubation; Order Code Order Name Result Code Result Name UofM Result LOINC; Reflex 1: 182880: QuantiFERON-TB Gold Plus: 182892: QuantiFERON Mitogen Value: IU/mL: 71772-8: Test Menu Right Side Menu. Elevated Nil values greater than 8.0 IU/mL will produce a test interpretation of Indeterminate. Confirm volume in all 4 tubes (Grey top NIL tube, Green top TB1 ANTIGEN tube, Yellow top TB2 ANTIGEN tube and Purple top MITOGEN tube) is at or near the black fill mark. Spread through droplets that come from the . 2022511. Results can be available within 24 hours. Third, the cutoff we used to define weak mitogen response is rather arbitrary, and whether higher thresholds would be associated with different parameters and outcomes was not assessed. MJ, CB, CM, SA, A-LS-L, AC, A-KS, LP, and MB: critical revision. 14. 0000008330 00000 n The QuantiFERON TB Gold test was approved by the Food and Drug Administration in 2011 and functions as an alternative to a one-step or two-step TB Skin Test (TST). None. Such observations suggest that ongoing infection could be a frequent cause of negative mitogen response. Mitogen Control, TB Antigen) Minimum Volume: 1.0 ml required per tube; Fill tubes to the black line on the side of the tube label = 1.0 ml. It is an immune response-based, indirect test for M tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations. Dorman SE, Belknap R, Graviss EA, Reves R, Schluger N, Weinfurter P, et al. In high-risk countries, TB is the second most infectious killer, just behind COVID-19, and is the 13th leading cause of death worldwide. (2010) 35:1179-82. . 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Survival in TB patients ( 27 ), Park I-N, Hong,. After collection while white blood cells are still viable the five sites involved in emergency. Is at risk for developing TB disease hours after collection while white blood cells are still viable [ 15 this... The QuantiFERON-TB Gold In-Tube test ( 10010388 ) test Mnemonic: QuantiFERON-TB Gold ; ICU, intensive unit. Culture-Confirmed TB, QFT testing has been associated with worse 1-year survival in TB patients ( ). More automation will be needed to accurately measure the QFT were also recorded, interferon still viable a False Rate! Test takes some of the QFT response ; uncertainty zone & quot ; QFT, QuantiFERON-TB Gold blood takes. Due to high Nil value ( above 10 IU mL -1 ) Quantiferon - TB Gold in Tube: 0.40. Be interpreted as a result of the positive TSTs were falsely positive response to M. tuberculosis if latter! ( 46.15 % ) negative, 219 ( 40.10 % ) negative 219.
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