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A Study of Analytical and Clinical Sensitivity of Aptima SARS-CoV-2 Assay (Hologic) and Proposals of Complementary Tests for SARS-CoV-2 Detection in Low Viral Load Specimens.
La, My-Van; Koo, Seok Hwee; Jiang, Boran; Heng, Ying Xuan; Tan, Thean Yen.
  • La MV; Department of Laboratory Medicine, Changi General Hospital, 2 Simei Street 3, Singapore, 529889, Singapore.
  • Koo SH; Clinical Trials and Research Unit, Changi General Hospital, 2 Simei Street 3, Singapore, 529889, Singapore.
  • Jiang B; Department of Laboratory Medicine, Changi General Hospital, 2 Simei Street 3, Singapore, 529889, Singapore.
  • Heng YX; Department of Laboratory Medicine, Changi General Hospital, 2 Simei Street 3, Singapore, 529889, Singapore.
  • Tan TY; Department of Laboratory Medicine, Changi General Hospital, 2 Simei Street 3, Singapore, 529889, Singapore. tan.thean.yen@singhealth.com.sg.
Curr Microbiol ; 79(1): 29, 2021 Dec 14.
Article in English | MEDLINE | ID: covidwho-1568358
ABSTRACT
Early and accurate detection of SARS-CoV-2 is important for diagnosis and transmission control. The use of high-throughput and automated testing allows laboratories to better deliver diagnostic testing given manpower and resource limitations. We validated the clinical and analytical performance of the Hologic Panther Aptima SARS-CoV-2 assay with an emphasis on detection of specimens with low viral loads. The clinical performance was evaluated using 245 clinical specimens, against a comparator PCR-based laboratory developed test (LDT). The analytical performance was determined by replicate testing of contrived samples in a ten-fold dilution series (CT values 32-42, based on LDT). The Aptima assay had 96.7% overall percent agreement, 100% negative percent agreement and 88.1% positive percent agreement. It was able to consistently detect SARS-CoV-2 in contrived samples with CT = 32 by LDT (calculated 2354 copies/mL). The 95% limit of detection of the Aptima assay was estimated to be at LDT CT = 33 (equivalent to 870 copies/mL). The relative light units (RLU) × 1000 for 52 true positive clinical specimens was 962.2 ± 181.5, and that for the 186 true negative specimens was 264.6 ± 14.3. The Aptima assay was a reliable method with a high overall percent agreement against our comparator LDT. We propose that samples reported as negative by the Aptima assay with RLU > 350 be tested by a secondary method, in order to improve detection of samples with very low viral loads.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Curr Microbiol Year: 2021 Document Type: Article Affiliation country: S00284-021-02730-3

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Curr Microbiol Year: 2021 Document Type: Article Affiliation country: S00284-021-02730-3