Clinical and Analytical Evaluation of the Alinity m HR HPV Assay within the VALGENT-3 Framework

Abstract

Only clinically validated human papillomavirus (HPV) tests should be used in cervical cancer screening. VALGENT provides a framework to validate new HPV tests. In the VALGENT-3 study, the clinical accuracy of the recently launched Abbott Alinity m HR HPV assay (Alinity m) to detect cervical precancerous lesions was assessed against the standard comparator test (Hybrid Capture 2; HC2) and additionally against two previously validated alternative comparator tests (Abbott RealTime HR HPV and Roche cobas 4800 assays). Validation was conducted using 1,300 consecutive cervical samples from women attending an organized population-based cervical screening program enriched with 300 cytologically abnormal samples. Overall hrHPV test concordance was assessed by kappa values; the concordance for HPV-16 and HPV-18 was assessed for Alinity m, RealTime, and cobas, and the Linear Array (Roche) was used for more detailed genotyping concordance. In the total study population, the relative sensitivity and specificity for CIN2+ and CIN3+ of Alinity m compared to HC2 was 1.02 (95% CI:0.99–1.06) and 1.03 (95% CI:0.99–1.06), respectively. The relative specificity for ≤ CIN1 was 1.01 (95% CI:1.00–1.02) (all pni ≤ 0.001). Alinity m showed non-inferior clinical accuracy among women 30 years or older when cobas or RealTime were used as comparators. HPV genotype-specific concordance between Alinity m and the three comparator tests showed excellent agreement, with kappa values ranging between 0.82 and 1.00. In conclusion, Alinity m fulfils the international accuracy requirements for use in cervical cancer screening and shows excellent HPV genotype-specific concordance with three clinically validated HPV tests.

High-risk human papillomavirus genotype distribution among women with gynecology complaints in northwest Ethiopia

“…The Alinity m System offers fully automated continuous random access to different assays. It is a fully integrated and automated molecular analyzer introduced in 2019 [41]. Alinity m HR-HPV assay fulfills the international consensus guideline criteria for primary cervical cancer screening [42].…”

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.…”

“…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. 20 In that study, analytical verification of Alinity m SARS-CoV-2 confirmed the manufacturer's limit of detection claim of 100 copies/mL, with clinical evaluation performed on 203 residual nasopharyngeal swabs from symptomatic and asymptomatic individuals with suspected SARS-CoV-2 infection.…”

“…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.…”

Comparison of Alinity m HPV and cobas HPV assays on cervical specimens in diverse storage media

“…There are numerous commercial HPV tests currently marketed and used by clinical laboratories for cervical screening. However, only a few of them have been adequately validated with documented clinical performance characteristics per international guidelines, and those without such validations are considered unreliable [ [11] , [12] , [13] ].…”