Indeterminate, which means that the test could not give a definitive negative or positive result. The original contributions presented in the study are included in the article/Supplementary Material, further inquiries can be directed to the corresponding author. Posted: Feb 22nd, 2022 at 04:14PM Intens Care Med. Storage/Transport: Maintain tubes at room temperature (22C 5C). 0000001563 00000 n (2011) 15:R99. Results: A total of 872 patients were included. QuantiFERON-TB gold tests were performed by the same laboratory (virology laboratory of the Dijon University Hospital) according to manufacturer instructions. May 10, 2022 0000016156 00000 n 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). Sepsis was considered as severe if requiring ICU admission. Conclusion: QIAGEN Inc. Tel: +1.661.775.7480 www.quantiferon.com 27220 Turnberry Lane, Suite 200 Fax: +1.661.775.7479 www.qiagen.com Valencia, CA 91355 . Tuberculosis is generally rare in developed countries, but not impossible. *Correspondence: Mathieu Blot, mathieu.blot@chu-dijon.fr, https://www.frontiersin.org/articles/10.3389/fmed.2022.876864/full#supplementary-material, Creative Commons Attribution License (CC BY). Reference Range: Components Reference Interval; QuantiFERON-TB Gold In-Tube: Negative . Wang XY, Su BY, Chen ZY, Kuang HB, Guan P, Cao ZZ, Tan YJ. results cannot be interpreted as a result of low mitogen response or high background response. The clinical and biological characteristics of the three groups are compared in Table 1. Accessibility, SCHEDULE 1 HOUR FDA AUTHORIZED COVID-19 PCR TESTING, Order 1 Hour FDA Authorized Covid-19 PCR Testing, Legal, Court Ordered, Probation, DUI or Child Custody Drug Testing, Outcomes of The Anti-Vaccination Movement. (2014) 189:77-87. doi: 10.1164/rccm.201302-0365OC, 10. How it could be impacted and associated with outcomes is poorly known. HtMv\+yV7\9FlQrp5W9Q_iZ^_:hUJ~FH=5lp'-#,rzJm4('(tW# 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. Order LOINC Value. Dorman SE, Belknap R, Graviss EA, Reves R, Schluger N, Weinfurter P, et al. Cell Mediated Immune Response. Continuous variables were expressed as means standard deviation (SD) or medians and inter-quartile range (IQR), according to distribution, and categorical variables were expressed as frequencies and percentages. 0000010668 00000 n There are two types of tuberculosis latent TB and active TB. Significance of interferon-gamma response to mitogen in serial QuantiFERON-TB Gold In-Tube assay of routine laboratory practice. Suite 100Las Vegas, Lange B, Vavra M, Kern WV, Wagner D. Indeterminate results of a tuberculosis-specific interferon- release assay in immunocompromised patients. Also referred to as inactive TB or a TB infection, this type of tuberculosis is not contagious. Tebruegge M, de Graaf H, Sukhtankar P, Elkington P, Marshall B, Schuster H, et al. Comparison of two commercial interferon-gamma assays for diagnosing Mycobacterium tuberculosis infection. Comparisons were made between the 3 groups using Kruskall-Wallis test for continuous variable, and the Chi-square test for qualitative variables. J Investig Med. Infections are frequent in hospitalized patients, but our results suggest QFT should not be performed until after recovery. quantiferon mitogen minus nil normal range. The results are valid for all cases that would normally need a TB skin test. Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, China, West China Hospital, Sichuan University, China. However, as with a TST, there is a possibility that live vaccines might affect the test results of the QuantiFERON TB Gold test. 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. 24. Ashlee Arnold. This test performed on whole blood, detects active/latent tuberculosis and is more sensitive and specific than the tuberculin (PPD . Before False Discovery Rate post hoc correction for multiple comparisons was used and P value reported in the figure : *P < 0.05; **P < 0.01. Log-linearity was tested for each continuous variable using fractional polynomials (20). Latent TB can become active TB after several weeks, or even years, after infection. 0000034863 00000 n The QuantiFERON-TB Gold . It does not distinguish between active and inactive tuberculosis. Tuberculosis, or TB, is a highly contagious and infectious airborne disease that affects the respiratory system, particularly the lungs. However, our study is novel in that it is the first study to observe an association between mitogen response and clinical outcomes in hospitalized patients. A total of 872 patients were included. '*A Reference range is a set of values which helps the healthcare professional to interpret a medical test. Careers. Requires a single patient visit to draw a blood sample. (2009) 33:812-5. doi: 10.1183/09031936.00075008, 8. 11 38 Clin Chim Acta 2014;430:79-83. (2005) 44:561-71. Mitogen is a very insensitive marker, and only mitogen is slightly . The Mitogen minus Nil value serves as the positive control, demonstrating the successful responsiveness of the T lymphocytes in patient specimen. 0000004397 00000 n $149.00. 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. . To account for potential confounders, polytomous logistic regressions were fitted considering the normal mitogen response group as the reference. Assessment of the accuracy of these tests is limited by lack of a standard for confirming LTBI. We recognize that technique may not be the only factor and we accept that mitogen values are currently not in a range that customers have previously observed. May also include abnormal ranges. Eur Respir J. Brown J, Kumar K, Reading J, Harvey J, Murthy S, Capocci S, et al. The Nil sample adjusts for background, heterophile antibody effects, or non-specific IFN- in blood samples. 0000001308 00000 n QuantiFERON-TB Gold In-Tube (QFT-GIT), the third generation test, has replaced QuantiFERON-TB (QFT) and QuantiFERON-Gold, which are no longer marketed. Accessibility A diagnosis of LTBI requires that TB disease be excluded by medical evaluation, which should include checking for signs and symptoms suggestive of TB disease, a chest radiograph, and, when indicated, examination of sputum or other clinical samples for the QFT result by category Total number tested Incident TB (324 months) . Indeterminate due to Low Mitogen Value: Indeterminate due to a low IFN-gamma level in the mitogen (positive control) tube. . Also referred to as TB disease, this type of tuberculosis is contagious. If a patient underwent several QFTs during the study period, only the first was retained for the analysis. The test is based on the quantification of interferon-gamma (IFN-) released from sensitized lymphocytes in whole blood incubated overnight with purified protein derivative (PPD) from M. tuberculosis and control antigens. The mitogen tube must demonstrate an interferon- value of equal to or greater than 0.5 IU/ml higher than the value of the NIL tube. Proportion of patients with infectious complications during hospital stay after QFT sampling. After the blood sample is taken and analyzed, the QuantiFERON TB Gold test will render one of the following results: Negative or Normal. 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). TB2 or both are in the low positive range of 0.35 to 0.70 u/l. LabReqs. A positive IGRA result may not necessarily indicate TB infection, but can also be caused by infection with non-tuberculous mycobacteria. [3] In addition to the multicenter study, two other published studies have demonstrated moderate concordance between TST and QFT. Crit Care. PWM and PHA were heat stable, while Con A was heat sensitive. Applies only to results expressed in units of measure originally reported by the performing laboratory. xref 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. Frequency and significance of indeterminate and borderline Quantiferon Gold TB IGRA results. In addition, mitogen response was inversely correlated with C-reactive protein concentrations (Figure 1). In conclusion, it appears to be of utmost interest to consider the mitogen response in hospitalized patients who undergo QFT, in particular when this response is negative or weak (IFN- 2 IU/mL). Torres LK, Pickkers P, van der Poll T. Sepsis-Induced Immunosuppression. The site is secure. Table 2 . Mitogen-Nil The maximum non-specific stimulated interferon- gamma level that may be produced by the patient's lymphocytes minus the Nil (i.e., basal) level of interferon-gamma. 9:876864. doi: 10.3389/fmed.2022.876864. Conclusion: 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. 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). 702-921-9461, Close to Las Vegas Airport / Across from Vons, 2051 N. Rainbow Blvd, 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. It only takes a few seconds! The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fmed.2022.876864/full#supplementary-material. 0000002316 00000 n J Clin Microbiol. When the variable a severe infection at the time of the QFT was added in the model instead of an ongoing infection at the time of QFT (model 4), this first was independently associated with a negative mitogen response (RR = 2.78; 95% CI [1.037.51]) (Supplementary Table 4 and Supplementary Figure 3). . . 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 This test performed on whole blood, detects active/latent tuberculosis and is more sensitive specific... Airborne disease that affects the respiratory system, particularly the lungs 04:14PM Intens Care Med Lane Suite. Hospitalized patients, but not impossible with non-tuberculous mycobacteria TB disease, this type tuberculosis! 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