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    Comparative evaluation of a new-generation HBsAg assay versus a conventional method in occult HBV infection and low-level HBsAg positivity
    (Ankara Microbiology Society, 2026) Daşdemir, Ferhat Osman; Dinç, Harika Öykü; Sirekbasan, Serhat; Hamzeli, Nur; Alaçam, Sema; Karabulut, Nuran; Türk, Süreyya; Dereli, Nida; Akçin, Rüveyda; Kocazeybek, Bekir
    This study aimed to comparatively evaluate the conventional hepatitis B surface antigen (HBsAg) assay and the next-generation HBsAg NEXT (HBsAgNx) assay in samples with low-level HBsAg positivity and in cases of occult hepatitis B infection (OBI). A total of 497 individuals were included in the study, comprising 300 individuals with low-level HBsAg positivity, 100 OBI cases (64 seropositive and 36 seronegative) and 97 healthy controls. Serum samples were analyzed using the Abbott ARCHITECT HBsAg Qualitative II assay (Abbott Diagnostics, Wiesbaden, Germany) and the Abbott Alinity i HBsAg NEXT assay (Abbott Diagnostics, Wiesbaden, Germany). The presence of HBV DNA was confirmed by real-time polymerase chain reaction (Rt-PCR) using the COBAS AmpliPrep/COBAS TaqMan HBV test v2.0 (Roche Diagnostics, Mannheim, Germany). HBV DNA (Rt-PCR) was accepted as the gold standard reference for diagnostic performance evaluation. To minimize potential bias arising from sample selection, individuals with low level HBsAg positivity and OBI cases were analyzed separately. In the low-level HBsAg-positive group, semi-quantitative S/CO values of the assays were compared, whereas in the OBI group, only the detection rates of HBV DNA–positive cases were evaluated. A total of 17 OBI cases (17%) were identified that were tested negative by the conventional assay but positive by the HBsAgNx assay. Differences between the assays were evaluated using the McNemar test and p< 0.05 was considered statistically significant. Median values obtained with the HBsAgNx assay were significantly higher than those obtained with the conventional assay (p< 0.001). The HBsAgNx assay provides clinically significant contributions particularly in the OBI group, by detecting cases that cannot be identified by conventional assays. These findings indicate that the integration of high-sensitivity HBsAg assays into current HBV diagnostic algorithms would increase case detection and contribute to both transfusion safety and the clinical management of OBI.
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    Evaluation of the diagnostic performance of a SARS-CoV-2 and Influenza A/B combo rapid antigen test in respiratory samples
    (MPDI, 2023) Dinç, Harika Öykü; Karabulut, Nuran; Alaçam, Sema; Kırkoyun Uysal, Hayriye; Daşdemir, Ferhat Osman; Önel, Mustafa; Tuyji Tok, Yeşim; Sirekbasan, Serhat; Agaçfidan, Ali; Gareayaghi, Nesrin; Çakan, Hüseyin; Eryiğit, Önder Yüksel; Kocazeybek, Bekir
    This study aimed to evaluate the performance characteristics of a rapid antigen test developed to detect SARS-CoV-2 (COVID-19), influenza A virus (IAV), and influenza B virus (IBV) (flu) compared with those of the real-time reverse transcription-polymerase chain reaction (rRT-PCR) method. One hundred SARS-CoV-2, one hundred IAV, and twenty-four IBV patients whose diagnoses were confirmed by clinical and laboratory methods were included in the patient group. Seventy-six patients, who were negative for all respiratory tract viruses, were included as the control group. The Panbio™ COVID-19/Flu A&B Rapid Panel test kit was used in the assays. The sensitivity values of the kit were 97.5%, 97.9%, and 33.33% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load below 20 Ct values. The sensitivity values of the kit were 16.7%, 36.5%, and 11.11% for SARS-CoV-2, IAV, and IBV, respectively, in samples with a viral load above 20 Ct. The kit’s specificity was 100%. In conclusion, this kit demonstrated high sensitivity to SARS-CoV-2 and IAV for viral loads below 20 Ct values, but the sensitivity values were not compatible with PCR positivity for lower viral loads over 20 Ct values. Rapid antigen tests may be preferred as a routine screening tool in communal environments, especially in symptomatic individuals, when diagnosing SARS-CoV-2, IAV, and IBV with high caution.