We evaluated the analytical sensitivity, specificity and reproducibility of the ARCHITECT hepatitis B surface antigen (HBsAg) NEXT Qualitative (HBsAgNx; Abbott Ireland, Sligo, Ireland; list 04P76), HBsAg NEXT Confirmatory (Abbott Ireland; list 04P77), hepatitis B e-antigen (HBeAg) Qualitative and Quantitative (Abbott GmbH & Co. KG, Wiesbaden, Germany; list 06C32/07P24), anti-hepatitis B core antigen (anti-HBc II; Abbott GmbH & Co. KG; list 08L44), HIV antigen/antibody (Ag/Ab) Combo (Abbott GmbH & Co. KG; list 04J27) and AdviseDx SARS-CoV-2 IgG II (Abbott Ireland; list 06S60) assays. The performance of each assay was evaluated with or without assay modification to the assay's pipetting algorithm for DBS compared with either the on-market assay performance run with matched plasma samples or the on-market assay performance with serum or plasma as reported in each assay package insert. When required to achieve comparable performance to on-market assays with plasma samples, assay pipetting protocols were modified to use increased sample volumes. Modified assays are considered 'Research Use Only'. DBS sample stability was also assessed for samples run on the HBsAgNx, anti-HBc II and HIV Ag/Ab Combo assays.
Anti hbc 2
Manufactured by Abbott
Sourced in Germany
The Anti-HBc II is a laboratory test used to detect the presence of antibodies to the hepatitis B core antigen (anti-HBc) in human serum or plasma. This test is used as part of the assessment of hepatitis B virus (HBV) infection status.
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4 protocols using anti hbc 2
1
Evaluation of Diagnostic Assays for DBS
2
Blood Donor Screening for Transfusion-Transmissible Infections
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All the collected blood units were screened for TTIs in accordance with national donor screening guidelines. For serological testing, the automated chemiluminescent microparticle immunoassay analyzer ARCHITECT i2000 system (CMIA, Abbott Diagnostic, USA), with validated commercially available assays, was used for the detection of HBsAg (ARCHITECT HBsAg Qualitative), Anti-HCV (ARCHITECT Anti-HCV), HIV p24 antigen and anti-HIV-1&2 (ARCHITECT HIV Ag/Ab Combo), anti-HBc (ARCHITECT Anti-HBc II), and Anti-HBs (ARCHITECT Anti-HBs). All procedures were carried out according to the manufacturer's instruction, and the results were expressed as a signal to cut-off (S/CO), and S/CO > 1.0 was considered reactive. In addition to CMIA, blood units were also tested in parallel by individual nucleic acid test (ID-NAT) for HBV-DNA, HCV-RNA and HIV-1&2-RNA using The Procleix Ultrio Elite assay on the Panther system (Grifols, Spain) as indicated by the manufacturer's instructions. For initially reactive samples, the Ultrio Elite discriminatory assays for HIV-1/2, HCV, or HBV were performed.
3
Screening Blood Donors for Anti-HBc
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Blood donors were prospectively investigated for the presence of anti-HBc-antibodies (Anti-HBc II, ARCHITECT, ABBOTT, Wiesbaden, Germany) in addition to standard HBV screening consisting of HBV-ID-NAT (Cobas MPX-assay, Roche) and HBs-antigen chemiluminescent immunoassay (ARCHITECT, Abbott). During March 2017 (period I), all donations of whole blood, platelets, and plasma were included into the study. From April 2017 to February 2018 (period II), only first-time whole blood donors were included into the study. Anti-HBc-positive samples were confirmed using an anti-HBc inhibition assay performed at the Institute of Virology in Freiburg, Germany [12 (link)]. The assay applies a recombinant core antigen of HBV. The assay is approved by the Federal Institute for Vaccines and Biomedics Paul-Ehrlich Institute, Langen, Germany, for confirmatory testing of blood donors. In this study, discarded fresh frozen plasma (dFFP) of anti-HBc-confirmed positive donors were ultracentrifuged and reanalyzed by standard HBV-ID-NAT.
4
Comprehensive Infectious Disease Screening Protocol
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All participants had a sample taken to test for HIV, HBV, HCV and syphilis . HIV 1 and 2 antibodies and p24 antigen were tested using Abbott Architect Ag/Ab Combo. Hepatitis B core antibody (HBcAb) was tested using Abbott Architect Anti-HBc II. If this was positive, the sample was tested for Hepatitis B surface antigen (HBsAg). Hepatitis C Antibodies were tested using Abbott Architect Anti-HCV. Treponema pallidum antibody (Anti-TP) was tested using Abbott Architect Syphilis TP; if this was positive, Venereal Disease Research Laboratory VDRL was done. Participants were considered to have syphilis requiring treatment if both tests were positive.
Each of the initial tests above was completed using Chemiluminescent Immunoassay (CLIA) in pools of 4 participant samples. If a pool was positive, each sample was tested individually. This reduced the cost without reducing the sensitivity, as reported previously [18 ,19 ].
In addition, those identified as at risk of diabetes or hypercholesterolemia had samples taken for random blood glucose and lipid profile.
Each of the initial tests above was completed using Chemiluminescent Immunoassay (CLIA) in pools of 4 participant samples. If a pool was positive, each sample was tested individually. This reduced the cost without reducing the sensitivity, as reported previously [18 ,19 ].
In addition, those identified as at risk of diabetes or hypercholesterolemia had samples taken for random blood glucose and lipid profile.
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