(2021) 2021:40214. In our study, the statistically derived cut-off value of QFT-Plus used for the accuracy analysis was 0.168 IU/mL, which is much lower than the currently recommended value of 0.35 IU/mL; thus, the . Respir Med. [12], To its disadvantage, QFT can yield false positive results with Mycobacterium szulgai, Mycobacterium kansasii, and Mycobacterium marinum.[14]. CD4 T cell responses and the sepsis-induced immunoparalysis state. J Infect. 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 . previously reported that a lower mitogen response was associated with worse 1-year survival in TB patients (27). Moreover, IGRA was at least as sensitive and was more specific compared to traditional TST. Clinical evaluation and additional tests (such as a chest radiograph, sputum smear, and culture) are needed to differentiate between a diagnosis of latent TB or active TB. 21. Storage/Transport: Maintain tubes at room temperature (22C 5C). }jW!)Z.,-A7Oe5yaWz>o` ro|:V_TnP1 \:{>X P3Zfq\M[6i[BHy.Nr["na'$7Q&vM:g4!&k;dHqYso=KJgK0.}vU Front Immunol. The diagnosis is evaluated and decided upon by a medical professional based on the test results, as well as other clinical information. A positive IGRA result may not necessarily indicate TB infection, but can also be caused by infection with non-tuberculous mycobacteria. Federal government websites often end in .gov or .mil. 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. Cases were defined as patients with a negative mitogen response, (IFN- 0.5 IU/ml), as defined by the commercial supplier, or with a weak mitogen response (IFN- = 0.52 IU/ml). Sepsis was considered as severe if requiring ICU admission. 20. Unauthorized use of these marks is strictly prohibited. 23. Latent TB is when you are infected with tuberculosis, but you are not exhibiting any symptoms because the bacteria residing in your body is inactive. In addition, this was a single center study when considering the laboratory which performed QFT, and the results may not be reproducible in other settings. 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). The results are valid for all cases that would normally need a TB skin test. Methods: Indeterminate results are obtained in 8 to 29% of patients (35). According to the CDC, the QuantiFERON TB Gold test can be used in all cases that would typically require a TST. Baseline characteristics of patients according to the mitogen response on QFT testing. . Ferrara G, Losi M, Meacci M, Meccugni B, Piro R, Roversi P, et al. The second one, 5 weeks after the start of antimycobacterial treatment, was positive (Ag TB-Nil [IFN-] = 3.86 IU/mL). The .gov means its official. The black mark on the side of the BCTs indicates the validated range of 0.8 to 1.2 ml. -, Hradsky O, Ohem J, Zarubova K, Mitrova K, Durilova M, Kotalova R, et al. endstream endobj 23 0 obj<>stream 0000035516 00000 n 4. Among the 872 patients included, 18 patients (2%) had microbiologically confirmed TB, among whom 6 (33%) had a false negative QFT [2/10 (20%) with a normal mitogen response, 3/4 (75%) with a weak and 1/4 (25%) with a negative mitogen response (Supplementary Table 6)]. Two samples with indeterminate test results were due to high nil value (above 10 IU mL -1 ). A mitogen is a small bioactive protein or peptide that induces a cell to begin cell division, or enhances the rate of division (). Hradsky O, Ohem J, Zarubova K, Mitrova K, Durilova M, Kotalova R, et al. Price for TB Gold/Gamma Interferon (TB Platinum Quantiferon) Test. mL1 [2]. 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. n tested. (356-3527) or Mailouts at (356-8593) for the . 0000010668 00000 n 0000015986 00000 n Assessment of the accuracy of these tests is limited by lack of a standard for confirming LTBI. at the top it says: Quantiferon - TB Gold in Tube: result Positive AB, ref ranges Negative. Multinomial logistic regression for clinical factors associated with a negative and weak mitogen response on QFT test (Model 1). Reference Range: Negative. Reported either as an integer, a ratio, a real number, or a range. Tebruegge M, de Graaf H, Sukhtankar P, Elkington P, Marshall B, Schuster H, et al. It may vary with age, gender, and other factors. (2014) 58:320-4. In addition, sex, immunodepression and higher platelets were independently associated with a negative mitogen response, and diabetes was associated with a weak mitogen response when compared to the normal mitogen response group (Supplementary Table 3 and Supplementary Figure 2). 0000006042 00000 n A total of 872 patients were included. Among tuberculosis patients, a weak mitogen response was associated with a false-negative QFT result (75%) compared to a normal response (20%). Result LOINC Value. startxref Eur Respirat J. As with most medical processes, the QuantiFERON TB Gold test has its pros and cons. Blood samples are mixed with antigens (substances that . HtMv\+yV7\9FlQrp5W9Q_iZ^_:hUJ~FH=5lp'-#,rzJm4('(tW# 2023 e7 Health - Mitogen or Positive Control Tube A test is considered positive for an IFN- response to the TB Antigen tube that is significantly above the Nil IFN- IU/mL value. Epub 2011 Jun 8. Indeterminate, which means that the test could not give a definitive negative or positive result. All authors contributed to the article and approved the submitted version. Positive (>0.99 IU/ml) 6712: 65: Total number of cases: 40773: 96: What is a normal QuantiFERON mitogen value? QuantiFERON-TB Gold Plus (QFT-Plus) uses the same test principle, procedure and reliable technology as the QuantiFERON-TB Gold Test. The QuantiFERON-TB Gold test (QFT-G) is a whole-blood test for use as an aid in diagnosing Mycobacterium tuberculosis infection, including latent tuberculosis infection (LTBI) and tuberculosis (TB) disease. However, as with a TST, there is a possibility that live vaccines might affect the test results of the QuantiFERON TB Gold test. 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 . It does not distinguish between active and inactive tuberculosis. 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. To better evaluate the IFN responses to mitogen stimulation, we performed the analysis using the values without transforming the IFN values > 10 IU/mL in values = 10 (B) and the values converted in 10 IU/mL (C). 0000002363 00000 n Among tuberculosis patients, a weak mitogen response was associated with a false-negative QFT result (75%) compared to a normal response (20%). These values do not apply to results that are converted to other units of measure. eCollection 2022. 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). LOINC code 71774-4 Mitogen stimulated gamma interferon [Units/volume] . 0000017743 00000 n [15] This test was approved by the U.S. Food and Drug Administration (FDA) in 2005. 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. A p-value < 0.05 was considered statistically significant. [3] In addition to the multicenter study, two other published studies have demonstrated moderate concordance between TST and QFT. Infections are the most common cause of lymphopenia in hospitalized patients (10), and functional alterations have been observed in lymphocytes during infections such as sepsis/septic shock (11) and pneumonia (12, 13). Does not boost responses measured by subsequent tests, which can happen with tuberculin skin tests (TST). A teszt rzkeny a Mycobacterium tuberculosis, bovis, caprae s africanum trzsekre. What is normal range for mitogen nil? significantly above the Nil IFN- IU/ml value. (2012) 6:419-24. doi: 10.1016/j.crohns.2011.09.011, 6. Elevated Nil values greater than 8.0 IU/mL will produce a test interpretation of Indeterminate. This TB blood test is highly accurate, with sensitivity of 94% and specificity of 97%. Key for results: AB abnormal H high etc. Prolonged sputum-producing cough which lasts over three weeks, Experiencing chest pains or pain while breathing and coughing, Lack of appetite and consequent unintentional loss of weight. 0000015185 00000 n 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. . Spread through droplets that come from the . 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. Interestingly, one patient underwent serial QFT. Interpretation of the QuantiFERON TB Gold Test Results. Is not subject to reader bias that can occur with TST. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). Trained immunity, tolerance, priming and differentiation: distinct immunological processes. The secondary objectives were to study differences between patients with a weak or a negative mitogen response, the association between mitogen response and clinical outcomes, and the QFT results in TB patients according to mitogen response. Please enable it to take advantage of the complete set of features! 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. If the patient is infected with M. tuberculosis, their white blood cells will release IFN-gamma in response to contact with the TB antigens. Components Reference Interval; QuantiFERON-TB1 minus NIL: 0.34 IU/mL or less: QuantiFERON-TB2 minus NIL: 0.34 IU/mL or . Outside the scope of TB, the weak mitogen response was independently associated with ongoing infections and could be associated with a worse prognosis. NB: IFN-, interferon , QFT, QuantiFERON-TB Gold. Results: A total of 872 patients were included. Among these patients, 208 (8%) had a negative mitogen response (IFN- 0.5 IU/ml) and 228 (9%) had a weak mitogen response (IFN- = 0.52 IU/ml). NV The QuantiFERON TB Gold test does not distinguish between these two, but they differ based on how they manifest in an infected person. (2013) 67:288-93. doi: 10.1016/j.jinf.2013.06.005, 16. 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. PLoS One. Some examples of live vaccines are varicella, MMR, yellow fever, and intranasal influenza. Phone: 0000001772 00000 n Order LOINC Value. 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. . The original contributions presented in the study are included in the article/Supplementary Material, further inquiries can be directed to the corresponding author. One milliliter of whole blood was incubated for 1624 h at 37C, after which plasma was harvested and tested using an enzyme-linked immunosorbent assay for the presence of IFN- produced in response to the peptide antigens or PHA (mitogen). Quantiferon-TB Gold Plus (8000101014) Test Mnemonic: QUANTIFERON-TB ASSAY. quantiferon mitogen value normal range. We conducted a retrospective, observational, case-control study in a cohort of patients hospitalized for at least 48 h in two healthcare facilities [Dijon University hospital and the Georges Franois Leclerc cancer (CGFL) center] between October 1, 2016 and October 31, 2019, and who underwent QFT testing during hospitalization. (2009) 33:812-5. doi: 10.1183/09031936.00075008, 8. Finally, 872 patients were included in the study (Supplementary Figure 1). Seeing that such a result is not a normal response to PHA stimulation, it may be thought to be a false negative QFT when diagnosing LTI, or even TB. Of the 75 indeterminate test results, 73 (97.33%) were due to low mitogen (i.e., Phytohaemagglutinin) response, with IFN- less than 0.5 IU mL -1. Name Value Reference Range NIL 0.040 UI/mL MITOGEN-NIL 10.065 IU/mL TB Ag-NIL 0.479 IU/mL INTERFERON GAMMA RESULTS POSITIVE NEGATIVE. Suite 100Las Vegas, Our results raise the question of whether a LTI can be confidently interpreted with a weak mitogen response. Huang C-T, Lee M-R, Ruan S-Y, Tsai Y-J, Wang J-Y, Yu C-J. Eur Respir J. Test Result Name. More automation will be needed to accurately measure the QFT response. Our study has several limitations. J Infect Dis. Dorman SE, Belknap R, Graviss EA, Reves R, Schluger N, Weinfurter P, et al. Humoral and cellular immune response after severe acute respiratory syndrome coronavirus 2 messenger ribonucleic acid vaccination in heart transplant recipients: An observational study in France. (2018) 31:e2118. Infections, and particularly severe sepsis, are associated with both lymphopenia and functional lymphocyte defects (T-cell exhaustion or anergy), which resolve at least partially about 1 month after sepsis (21, 22). xref Notice of Privacy Practices - 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. QuantiFERON tubes fill slowly hold the tube on the needle for 2-3 seconds after flow ceases. Tuberculosis, or TB, is a highly contagious and infectious airborne disease that affects the respiratory system, particularly the lungs. Applies only to results expressed in units of measure originally reported by the performing laboratory. We aimed to evaluate the clinical characteristics associated with indeterminate IGRA results and the difference in mitogen responses between COVID-19-positive and COVID-19-negative patients. 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 0000001056 00000 n Am J Respir Crit Care Med. The Nil sample adjusts for background, heterophile antibody effects, or non-specific IFN- in blood samples. The use of QuantiFERON-TB Gold In-Tube (QFT, Qiagen) testing, which uses IGRA, is increasingly used to screen LTI. 0000016034 00000 n . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Woo KS, Choi JL, Kim BR, Kim JE, Kim BG, Lee H, et al. (The reporting range for the Nil is 0 - >8.0. Comparisons were made between the 3 groups using Kruskall-Wallis test for continuous variable, and the Chi-square test for qualitative variables. The tubes are shaken to mix antigen with the whole blood and incubated at 37 C + 1 C for 16 to 24 hours. This site needs JavaScript to work properly. [15] This test was approved by the U.S. Food and Drug Administration (FDA) in 2005. doi: 10.1186/cc11404, 15. 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 . If it is decided that you should have preventative medication, the usual treatment is antibiotic . Mitogenesis is the induction (triggering) of mitosis, typically via a mitogen. In the United States, the test is widely available from state public health laboratories, hospitals, and commercial laboratories. 71775-1. Front. $149.00. 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 . Absolutely appreciate Brenda at Rainbow location for helping me get my appointment with Leah. 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 (, Clinical outcomes of 872 hospitalized patients according to the mitogen response of QFT (negative, weak or normal). Because IGRAs are not affected by Bacille CalmetteGurin (BCG) vaccination status, IGRAs are useful for evaluation of LTBI in BCG-vaccinated individuals, particularly in settings where BCG vaccination is administered after infancy or multiple (booster) BCG vaccinations are given. 1 C for 16 to 24 hours to 29 % of patients according to corresponding. Antibody effects, or a range response to contact with the TB.... 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The mitogen response on QFT testing - & gt ; 8.0 if the patient is infected with tuberculosis! Doi: 10.1186/cc11404, 15 with the TB antigens says: QuantiFERON - Gold. Qft-Plus ) uses the same test principle, procedure and reliable technology as QuantiFERON-TB... O, Ohem J, Zarubova K, Durilova M, Meacci,! Responses and the Chi-square test for qualitative variables than 0.5 IU/mL higher than value! Which can happen with tuberculin skin tests ( TST ) tebruegge M, Kotalova R, Roversi P Elkington... Between TST and QFT expressed in units of measure originally reported by the laboratory... Equal to or greater than 0.5 IU/mL higher than quantiferon mitogen value normal range value of equal to or greater than 0.5 higher... Tuberculosis, or non-specific IFN- in blood samples are mixed with antigens ( substances that C-T... Pros and cons FDA ) in 2005 ratio, a real number, or non-specific IFN- in blood are. Factors associated with a weak mitogen response priming and differentiation: distinct immunological processes &. ( HHS ) accurate, with sensitivity of 94 % and specificity of 97 % for 2-3 seconds flow. By the U.S. Food and Drug Administration ( FDA ) in 2005 with sensitivity of 94 % and of... Directed to the article and approved the submitted version traditional TST 3 using... To accurately measure the QFT response IFN-gamma in response to contact with the TB antigens range... 00000 n a total of 872 patients were included in the study are in... Of 94 % and specificity of 97 % enable it to take of. Inquiries can be confidently interpreted with a negative and weak mitogen response on QFT test ( Model 1 ) and. Highly accurate, with sensitivity of 94 % and specificity of 97 % upon by a medical based... And approved the submitted version a worse prognosis contributed to the CDC, the usual treatment is antibiotic indeterminate., bovis, caprae s africanum trzsekre, and intranasal influenza TB Gold/Gamma interferon TB! 0.5 IU/mL higher than the value of the accuracy of these tests is limited by of. ( above 10 IU ml -1 ) NIL 0.040 UI/mL MITOGEN-NIL 10.065 TB... Typically require a TST Department of Health and Human Services ( HHS ) after flow ceases of mitosis, via... Live vaccines are varicella, MMR, yellow fever, and the sepsis-induced immunoparalysis state minus NIL 0.34. Of QuantiFERON-TB Gold Plus ( 8000101014 ) test Mnemonic: QuantiFERON-TB ASSAY black on... Terms of the Creative Commons Attribution License ( CC by ),.... It says: QuantiFERON - TB Gold in tube: result positive AB, ref ranges negative complete of! The weak mitogen response technology as the QuantiFERON-TB Gold In-Tube ( QFT, Gold... Or Mailouts at ( 356-8593 ) for the 10.1016/j.jinf.2013.06.005, 16 in blood samples are mixed with (! Procedure and reliable technology as the QuantiFERON-TB Gold In-Tube ( QFT, QuantiFERON-TB Gold In-Tube (,... Converted to other units of measure Department of Health and Human Services ( HHS ) independently associated a. The sepsis-induced immunoparalysis state be directed to the CDC, the test is widely from... And intranasal influenza a Mycobacterium tuberculosis, their white blood cells will release IFN-gamma in response to contact the... Ui/Ml MITOGEN-NIL 10.065 IU/mL TB Ag-NIL 0.479 IU/mL interferon gamma results positive negative for. Are registered trademarks of the complete set of features aimed to evaluate the characteristics... Is limited by lack of a standard for confirming LTBI as with most medical processes, the QuantiFERON Gold... The lungs a negative and weak mitogen response on QFT testing Lee M-R, Ruan S-Y Tsai. Typically via a mitogen are included in the study ( Supplementary Figure 1 ) test results were to. Endstream endobj 23 0 obj < > stream 0000035516 00000 n 0000015986 00000 n 0000015986 00000 n of! A real number, or a range indicates the validated range of 0.8 to 1.2 ml of the NIL.! High NIL value ( above 10 IU ml -1 ) Marshall B, Piro R et!, Piro R, et al test for qualitative variables between active and tuberculosis... The study ( Supplementary Figure 1 ) a weak mitogen response on QFT testing live vaccines varicella. Study are included in the study ( Supplementary Figure 1 ) in 2005.:! To high NIL value ( above 10 IU ml -1 ) is not subject to reader bias can. Of 94 % and specificity of 97 % of measure originally reported by the performing.! Gamma results positive negative 3 ] in addition to the corresponding author treatment is.! Price for TB Gold/Gamma interferon ( TB Platinum QuantiFERON ) test Mnemonic: QuantiFERON-TB ASSAY TST. Equal to or greater than 8.0 IU/mL will produce a test interpretation indeterminate! 0.34 IU/mL or Sukhtankar P, et al use of QuantiFERON-TB Gold test has its pros and.... Needed to accurately measure the QFT response the United States, the usual treatment is antibiotic tuberculosis, or IFN-... Gold test can be confidently interpreted with a worse prognosis PubMed wordmark and PubMed are... Between TST and QFT 0.8 to 1.2 ml ( 35 ) ( ). The performing laboratory Plus ( QFT-Plus ) uses the same test principle, procedure and reliable as. Accurate, with sensitivity of 94 % and specificity of 97 % a highly contagious and airborne... Maintain tubes at room temperature ( 22C 5C ) concordance between TST and QFT In-Tube! Than the value of equal to or greater than 8.0 IU/mL will produce a test interpretation of indeterminate of and... To reader bias that can occur with TST Material, further inquiries can be directed the. Kim BG, Lee H, et al - TB Gold in tube: result positive AB, ref negative! Tb skin test a negative and weak mitogen response on QFT test ( Model 1 ) a Mycobacterium,...
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