The clinical performance of The BD Onclarity HPV Assay with respect to histology end points was similar to HC2. Moreover, discordant analysis revealed improved performance of the BD assay with respect to ability to provide extended genotyping information and lack of cross-reactivity with low-risk HPV types associated with cellular abnormalities. The relative risks for CIN 3 disease for HPV 31 and HPV 33/58 (combined) were comparable to that of HPV 18 in this population, suggesting that these genotypes may warrant monitoring in future studies.

We evaluated the effect of storage at 2 to 8°C on the stability of human genomic and human papillomavirus (HPV) DNA stored in BD SurePath and Hologic PreservCyt liquid-based cytology media. DNA retained the ability to be extracted and PCR amplified for more than 2.5 years in both medium types. Prior inability to detect DNA in archived specimens may have been due to failure of the extraction method to isolate DNA from fixed cells. Liquid-based cytology (LBC) media (BD SurePath [Becton, Dickinson and Company] and Hologic PreservCyt [Hologic Inc.]) are routinely used to prepare liquid Pap preparations for cervical cancer screening. In the United States, molecular human papillomavirus (HPV) testing out of the LBC vial is recommended (i) as a triage test for determining whether a woman with atypical squamous cells of undetermined significance (ASC-US) needs immediate colposcopic evaluation and (ii) as an adjunct to cervical cytology, "cotesting," for cervical cancer screening of women of age 30 years and older. In addition, there is a growing interest in the use of LBC media for primary HPV screening in which positive specimens could be reflexed to cytology, HPV type-specific genotyping, or another triage method, although molecular tests have yet to be approved for this intended use (1, 2). LBC media were originally developed and approved for the preservation and preparation of cells for Pap smear evaluation (3, 4). BD SurePath and Hologic PreservCyt media are both alcohol-based preservatives and are designed to fix cellular and subcellular components and aid in the cytological evaluation of the obtained smears. Fixative solutions can prove problematic for downstream molecular extraction methods because of the potential to inhibit cellular lysis, because of the potential to interfere with the proteolytic enzymes used in this process, or due to cross-linking of nucleic acids and proteins (5, 6). Some prior studies have reported poor recovery of nucleic acids from SurePath and PreservCyt media and inferred that the DNA had degraded over time during storage (7-10). SurePath medium contains a low concentration of formalin, which is known to cross-link nucleic acids and protein (11,12). Formalin treatment results in reversible cross-linking of proteins to DNA, which can render it refractory to magnetic-or silica-based purification and subsequent downstream nucleic acid biochemistry, such as PCR (13). Cross-linking can be removed using proteinase K digestion and/or heat (14-16).We have developed a simple, one-step chemical lysis method for use with the BD hrHPV-GT assay that can process 0.5 ml of either LBC specimen without prior cell harvesting or the use of lytic enzymes. The method uses a combination of heat and chemicals to lyse LBC-preserved cells directly in the media. It also efficiently reverses cross-linking effects and allows biologically active DNA to be extracted directly from the resulting lysate (17-19).The objective of the current study was to examine the effect of long-term storage of LBC specimens at 2 ...

Background Nucleic acid amplification testing (NAAT) for SARS-CoV-2 is the standard approach for confirming COVID-19 cases. This study compared results between two Emergency Use Authorization (EUA) NAATs, with two additional EUA NAATs utilized for discrepant testing. Methods The limits of detection (LOD) for the BD SARS-CoV-2 Reagents for BD MAX™ System (“MAX SARS-CoV-2 assay”), the Biomerieux BioFire® Respiratory Panel 2.1 (“BioFire SARS-CoV-2 assay”), the Roche cobas SARS-CoV-2 assay (“cobas SARS-CoV-2 assay”), and the Hologic Aptima® SARS-CoV-2 assay Panther® (“Aptima SARS-CoV-2 assay”) NAAT systems were determined using a total of 84 contrived nasopharyngeal specimens with seven target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) of the MAX SARS-CoV-2 assay, compared to the Aptima SARS-CoV-2 assay, was evaluated in a post-market clinical study utilizing 708 nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant testing was achieved using cobas and BioFire SARS-CoV-2 NAATs. Results In this study, the measured LOD for the MAX SARS-CoV-2 assay (251 copies/mL; [95%CI: 186, 427]) was comparable to the cobas SARS-CoV-2 assay (298 copies/mL; [95%CI: 225, 509]) and the BioFire SARS-CoV-2 assay (302 copies/mL; [95%CI: 219, 565]); the Aptima SARS-CoV-2 assay had a LOD of 612 copies/mL; [95%CI: 474, 918]. The MAX SARS-CoV-2 assay had a PPA of 100% (95%CI: [97.3%-100.0%]) and a NPA of 96.7% (95%CI: [94.9%-97.9%]) when compared to the Aptima SARS-CoV-2 assay. Conclusions The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA assay.

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Background The RT-qPCR assay for detecting SARS-CoV-2 virus is the favorable approach to test suspected COVID-19 cases. However, discordant results can occur when two or more assays are compared. Variability in analytical sensitivities between assays, among other factors, may account for these differences in reporting. Methods The limits of detection (LOD) for the BD SARS-CoV-2 Reagents for BD MAXTM System ('MAX SARS-CoV-2 assay'), the Biomerieux BioFire® Respiratory Panel 2.1 ('BioFire SARS-CoV-2 assay'), the Roche cobas SARS-CoV-2 assay ('cobas SARS-CoV-2 assay'), and the Hologic Aptima® SARS-CoV-2 assay Panther® ('Aptima SARS-CoV-2 assay') RT-qPCR systems were determined using a total of 84 contrived nasopharyngeal specimens with seven target levels for each comparator. The positive and negative percent agreement (PPA and NPA, respectively) for the MAX SARS-CoV-2 assay were compared to the Aptima SARS-CoV-2 assay in a post-market clinical study utilizing 708 paired nasopharyngeal specimens collected from suspected COVID-19 cases. Discordant results were further tested by the cobas and BioFire SARS-CoV-2 assays. Results The measured LOD for the MAX SARS-CoV-2 assay (251 copies/mL) was comparable to the cobas SARS-CoV-2 assay (298 copies/mL) and the BioFire SARS-CoV-2 assay (302 copies/mL); the Aptima SARS-CoV-2 assay had a LOD of 612 copies/mL. The MAX SARS-CoV-2 assay had a PPA of 100% (95%CI: [97.3%-100.0%]) and a NPA of 96.7% (95%CI: [94.9%-97.9%]) when compared to the Aptima SARS-CoV-2 assay. Conclusions The MAX SARS-CoV-2 assay exhibited a high analytical sensitivity and specificity for SARS-CoV-2 detection. The clinical performance of the MAX SARS-CoV-2 assay agreed with another sensitive EUA cleared assay.