Multicenter clinical evaluation of alinity m HBV assay performance

Diagnosis and Monitoring of Hepatitis B Virus Infection Using the Cobas® HBV Test for Use on the Cobas® 4800 System

“…The present study, based on a large series of clinical specimens including samples with different HBV genotypes frequently encountered in clinical practice, showed that the cobas  HBV test accurately quantified HBV DNA in plasma. Its performance was in keeping with that of other real-time PCR or TMA-based platforms and assays frequently used in clinical practice [11,[13][14][15]. The cobas  HBV Test was very sensitive with an estimated LoD on the same order as that claimed by the manufacturer.…”

“…Frozen samples were tested with three different assays, including the real-time PCR-based cobas ® HBV Test and two commercially available assays with the CAP/CTM HBV Test v2.0 test and the Alinity™ m HBV assay, a PCR-based dual probe assay that is run on a fully automated Alinity m analyzer [11].…”

Improved molecular laboratory productivity by consolidation of testing on the new random-access analyzer Alinity m

“…A comparison of clinical performance was beyond the scope of the current study, which focused exclusively on the workflow metrics by utilizing simulated or residual specimens. Clinical performance data between Alinity m and various molecular assays is published elsewhere [18][19][20][21][22]. In these studies, the Alinity m HIV-1, HCV, HBV, HR HPV assays were found to be accurate and reproducible with high agreement to comparator assays.…”

Real-Life Head-to-Head Comparison of Performance of Two High-Throughput Automated Assays for the Detection of SARS-CoV-2 RNA in Nasopharyngeal Swabs

“…In 18/37 individuals with Alinity m SARS-CoV-2 / cobas 6800 SARS-CoV-2 discrepant results, previous and/or follow-up SARS-CoV-2 PCR result(s) were identified: 10/18 had a recorded previous SARS-CoV-2 PCR positive result in samples collected 0, 6, 8, 9, 9, 10, 11, 27, 59, 90 days (mean: 22.9 days; median: 9.5 days; range 0-90 days) before the sample in this study was collected (for multiple previous samples identified, the first previously positive sample was considered for each individual) and 8/18 had a recorded follow-up SARS-CoV-2 PCR positive result in samples collected 0, 0, 0, 2, 2, 5, 6, 7 days (mean: 2.8 days; median: 2 days; range 0-7 days) after the sample in this study was collected (for multiple follow-up samples identified, the first positive follow-up sample was considered for each individual). virus DNA; 13,17,19,21 (ii) quantitative detection of hepatitis C virus RNA; 12,17,18,21 (iii) quantitative detection of HIV-1 RNA; [15][16][17]21 (iv) qualitative detection of SARS-CoV-2 RNA; 20 (v) qualitative detection of 14 high-risk human papillomaviruses coupled with extended genotyping; 14,22 (vi) qualitative detection and differentiation of Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium, and Neisseria gonorrhoeae 23 and (vii) qualitative detection and differentiation of SARS-CoV-2, influenza A and B viruses, and respiratory syncytial virus. Twelve evaluations of Alinity m assays are available in peerreviewed literature, [12][13][14][15][16][17][18][19][20][21][22][23] but only a single analytical and clinical evaluation of Alinity m SARS-CoV-2 assay on a limited number of samples is known to have been published to date.…”

“…Alinity m (Abbott Molecular, Des Plaines, IL, USA) is another recently launched fully integrated, automated sample-to-result molecular analyzer allowing continuous loading of samples and random-access testing. Seven molecular assays have been developed for use with Alinity m, [12][13][14][15][16][17][18][19][20][21][22][23] including an assay for SARS-CoV-2, which received U.S. FDA EUA on 11 May J o u r n a l P r e -p r o o f aliquots were prepared: 800 µl for Alinity m SARS-CoV-2 testing and 700 µl for cobas 6800 SARS-CoV-2 testing.…”