IGRA Test Reliability. How Test Design and Lab Control Impact Results

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1 IGRA Test Reliability How Test Design and Lab Control Impact Results

2 IGRA Test Reliability Background Why IGRAs are uniquely challenging to both test manufacturers and labs Why complexity exists with both IGRAs How IGRA test design and lab control of test processes address these challenges

3 Background IGRA s are uniquely challenging for test manufacturers and clinical laboratories for two primary reasons: 1. They require T-cell survival and functionality after phlebotomy to produce accurate results, and the duration of time that cells remain viable is short This short timing window creates significant logistical challenges Both test manufacturers have designed and implemented product enhancements to address these challenges, using distinctly different approaches 2. In addition to time, numerous other factors can affect ex vivo T-cell survival and functionality, and the design of the two tests differ significantly in how they address, or don t address these factors This leads to both IGRAs being complex, but in fundamentally different ways Question: which complexity choice is more advantageous for labs to manage?

4 IGRA Complexity Test Original Sample Stability Sample Stability Invention Pre-analytic Complexity Analytic Complexity.TB 8 hours T Cell Xtend None High QFT 12 hours In-Tube High Low-moderate IGRA Complexity Options No Complexity (send-out to ODL) Pre-analytic complexity (QFT) Analytic complexity (.TB)

5 Factors That Affect IGRA Results Drugs Sample Storage Phlebotomy Tubes IGRA Result Preanalytical steps Illnesses Granulocytes Endotoxin

6 Factor # 1: Drugs Many drugs have been shown to inhibit the production of interferon gamma (IFNγ): Tricyclic antidepressants suppress the release of IFNγ from T cells 1 Non-steroidal anti-inflammatory drugs reduce in vitro IFNγ production by T cells 2 Abatacept (used to treat rheumatoid arthritis) decreases the production of IFNγ from T cells in vitro 3 Potential impact on IGRAs: If present during incubation, these drugs will reduce the amount of IFNγ released by T cells, potentially leading to infected subjects having a negative result How the test avoids this problem: Washing step in the assay procedure removes drugs from the sample, which eliminates this factor from negatively impacting inhibition of IFNγ release 1 Xia Z et al. Immunopharmacology Aug; 34(1): Iñiguez MA et al. J Immunol Jul 1; 163(1): Wenink MH et al. Ann Rheum Dis Jan; 71(1): 80-3

7 Factor # 2: Conditions & Illnesses Numerous conditions and illnesses affect IFN γ release: IFNγ secreting cells and IFN γ levels increase during pregnancy 1 Non-tuberculous mycobacteria 2 infections, certain allergies 3 and diabetes 4 decrease IFNγ released from activated T cells Patients with Chlamydia 5 infections, Crohn s disease 6 and Alzheimer's 7 produce more IFNγ from T cells Potential impact on IGRAs: In particular, high background levels may make it difficult for tests to recognize small increases in IFNγ produced by the TB antigens How the test avoids this problem: The washing step in the lab procedure removes all background IFNγ before the T- SPOT test is run, so factors affecting IFNγ levels have no effect on the test 1 Matthiesen L et al Am J Reprod Immunol Jun;39(6): Kwon YS et al. Lung.2007 Dec;185(6): Suomalainen H, et al. Pediatr Allergy Immunol Ciampolillo A et al. Diabetes Res Clin Pract Aug-Sep;21(2-3): Roan et al. Proc Natl Acad Sci U S A Aug 8;103(32): Ogawa K et al. J Crohns Colitis Jun;6(5): Solerte SB et al. Aging Mar-Apr;21(2):271-81

8 Factor # 3: Endotoxin Contamination Endotoxin contamination of any reagents or test components will be recognized as being foreign by T cells, causing IFNγ release Potential impact on IGRAs: If antigen tubes or wells are contaminated, false positive results are likely to occur If nil control tubes or wells are contaminated, indeterminate results are likely to occur How the test avoids this problem: Any endotoxin contamination in the sample collection process is removed during the washing step, so it is not present during the incubation step Each batch of media used to make up the sample, controls and antigens is specifically tested for endotoxin contamination by the manufacturer

9 Factor # 4: Elevated Numbers of Granulocytes in Sample Certain conditions and illnesses increase granulocyte numbers, including heart attacks, burns and some drugs, including corticosteroids Common bacterial infections can increase granulocytes ten fold 1 Potential impact on IGRAs: Granulocytes produce peroxide, which inhibits IFNγ release Elevated levels of granulocytes in the sample may inhibit IFNγ release and lead to false negative results How the test avoids this problem: Granulocytes are dense and are removed from samples during centrifugation 1 Li Y et al. Proc Natl Acad Sci U S A.2002 Jun 11;99(12):

10 Factor # 5: Sample Storage Storing samples decreases the amount of IFNγ released during the incubation phase of an IGRA assay 1,2 Potential Impact on IGRAs: Decrease in IFNγ production 3 which can lead to false negative results and increased indeterminate rates What are the mechanisms that cause this? 1 Meier et al Eur J Clin Microbiol Infect Dis : Doberne et al J. Clin. Microbiol 2011 Aug;49(8): McKenna et al J Immunol Methods Feb 28;341(1-2):68-75

11 Cause of Decreased IGRA Performance in Stored Blood Storing blood for more than a few hours leads to granulocyte activation 1 Note: people with certain medical conditions can have activated granulocytes even in fresh blood Activated granulocytes produce H 2 O 2 (peroxide) 2 Peroxide inhibits T cell secretion of IFN γ 2 Adversely affects performance of IGRAs 1 1 McKenna et al J Immunol Methods Feb 28;341(1-2): Schmielau et al Cancer Res Jun 15;61(12):

12 Impact of Sample Storage on IGRA Results Studies show that spot counts decline if samples are stored for more than 8 hours Meier et al Eur J Clin Microbiol Infect Dis (2005) showed that spot counts declined in samples stored for 24 and 48 hours Doberne et al J. Clin. Microbiol (2011) showed that IFNγ levels declined in QFT when samples were stored for 6 and 12 hours Incubation Delay Mean IFN Produced % Reversions 0 hours 0.77 IU/mL NA 6 hours 0.35 IU/mL 19% 12 hours 0.19 IU/mL 22%

13 Factor # 5: Sample Storage (continued) How the test avoids this problem: Granulocytes are dense and are normally removed from samples during centrifugation When granulocytes are activated they become less dense, and remain in the PBMC layer after centrifugation T-Cell Xtend contains antibodies which bind to granulocytes and red blood cells, cross-linking them so that during centrifugation even activated granulocytes are removed Sample before preparation Pre-wash sample Purified sample 1 Meier et al Eur J Clin Microbiol Infect Dis : Doberne et al J. Clin. Microbiol 2011 Aug;49(8): McKenna et al J Immunol Methods Feb 28;341(1-2):68-75

14 Factor # 6: Pre-analytical Steps Some pre-analytical steps can introduce variability into the assay process Factors such as blood volume and tube shaking force affect T cell stimulation and subsequent release of IFNγ Potential impact on IGRAs: Blood volume will affect the relative concentration of T cells to the stimulatory antigens If tubes are not shaken sufficiently the stimulatory antigens are not effectively mixed with the T cells If tubes are shaken too strongly the gel may dislodge and mix with the blood, causing potentially erroneous results How the test avoids this problem: WBC numbers are standardized and a specific quantity of stimulatory antigens is added in the controlled conditions of the laboratory, ensuring the correct concentrations are consistently obtained Dissolved stimulatory antigens are added to the T cell solution in a microtiter plate, ensuring consistent interaction

15 Impact of Pre-analytical Steps: Shaking Gaur et al., J Clin Microbiol (2013) Key Findings: IFNγ levels are affected by mild or vigorous tube shaking Results can change from negative to positive if shaken more vigorously Amount of Shaking % Positive (n=40) Tb Ag Gen Nil Gen 32.5% Tb Ag Vig - Nil Vig 35.0% Tb Ag Gen - Nil Vig 27.5% Tb Ag Vig - Nil Gen 42.5%

16 Impact of Pre-analytical Steps: Blood Volume Gaur et al., J Clin Microbiol (2013) Key Findings: TB Antigen minus Nil response was affected by blood draw volume Increasing blood volume decreases test positivity Blood Volume (ml) Response IU/mL +ve Results in Subjects with LTBI % (15/17) % (12/17) % (10/17)

17 Factor # 7: Phlebotomy Tubes Manufacture of phlebotomy tubes which includes incorporation of test reagents can add complexity to the blood collection process and variability to the assay Variability of test components in the tubes will affect T cell stimulation and subsequent release of IFNγ Potential impact on IGRAs: Variability of reagents in the tubes can lead to erroneous results and increased indeterminate rates How the test avoids this problem: The equivalent components in the test are added in the laboratory under controlled conditions, thereby reducing this variability

18 Summary IGRAs are uniquely challenging for clinical laboratories because: They require T cell survival and functionality after phlebotomy to produce accurate results, and the time that cells remain viable is short Numerous other factors also affect ex vivo T cell survival and functionality To address these challenges, both IGRAs have significant complexity designed into their methodology

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