Comparison of diagnostic performance of five molecular assays for detection of SARS-CoV-2.

Kanwar, Neena; Banerjee, Dithi; Sasidharan, Anjana; Abdulhamid, Ayah; Larson, Marissa; Lee, Brian; Selvarangan, Rangaraj; Liesman, Rachael M

Kanwar, Neena; Banerjee, Dithi; Sasidharan, Anjana; Abdulhamid, Ayah; Larson, Marissa; Lee, Brian; Selvarangan, Rangaraj; Liesman, Rachael M.

Kanwar N; Department of Pathology and Laboratory Medicine, Children's Mercy, Kansas City, MO, USA; School of Medicine, University of Missouri- Kansas City, MO, USA.
Banerjee D; Department of Pathology and Laboratory Medicine, Children's Mercy, Kansas City, MO, USA; School of Medicine, University of Missouri- Kansas City, MO, USA.
Sasidharan A; Department of Pathology and Laboratory Medicine, Children's Mercy, Kansas City, MO, USA.
Abdulhamid A; Department of Pathology and Laboratory Medicine, Children's Mercy, Kansas City, MO, USA.
Larson M; Department of Pathology and Laboratory Medicine, University of Kansas Health System, Kansas City, KS, USA.
Lee B; School of Medicine, University of Missouri- Kansas City, MO, USA; Division of Health Services and Outcomes Research, Children's Mercy, Kansas City, MO, USA.
Selvarangan R; Department of Pathology and Laboratory Medicine, Children's Mercy, Kansas City, MO, USA; School of Medicine, University of Missouri- Kansas City, MO, USA; Department of Pathology and Laboratory Medicine, University of Kansas Health System, Kansas City, KS, USA. Electronic address: rselvarangan@cmh.e
Liesman RM; Department of Pathology and Laboratory Medicine, University of Kansas Health System, Kansas City, KS, USA. Electronic address: rliesman@kumc.edu.

Diagn Microbiol Infect Dis ; 101(4): 115518, 2021 Dec.

Article in English | MEDLINE | ID: covidwho-1347572

ABSTRACT

ABSTRACT

We compared the performance of the Abbott Real Time SARS-CoV-2 assay (Abbott assay), Aptima™ SARS-CoV-2 assay (Aptima assay), BGI Real-Time SARS-CoV-2 assay (BGI assay), Lyra® SARS-CoV-2 assay (Lyra assay), and DiaSorin Simplexa™ COVID assay for SARS-CoV-2 detection. Residual nasopharyngeal samples (n = 201) submitted for routine SARS-CoV-2 testing by Simplexa assay during June-July 2020 and January 2021 were salvaged. Aliquots were tested on other assays and compared against the CDC 2019-nCoV Real-Time RT-PCR assay. Viral load in positive samples was determined by droplet digital PCR. Among 201 samples, 99 were positive and 102 were negative by the CDC assay. The Aptima and Abbott assays exhibited the highest positive percent agreement (PPA) at 98.9% while the BGI assay demonstrated the lowest PPA of 89.9% with 10 missed detections. Negative percent agreement for all 5 platforms was comparable, ranging from 96.1% to 100%. The performance of all five assays was comparable.

Subject(s)

COVID-19 Testing/methods; COVID-19/diagnosis; Molecular Diagnostic Techniques/methods; SARS-CoV-2/isolation & purification; Adolescent; Adult; Aged; Aged, 80 and over; COVID-19/virology; Female; Humans; Male; Middle Aged; Nasopharynx/virology; Prospective Studies; Sensitivity and Specificity; Viral Load; Young Adult

Keywords

COVID-19; Molecular assay comparison; SARS-CoV-2 detection

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Molecular Diagnostic Techniques / COVID-19 Testing / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Diagn Microbiol Infect Dis Year: 2021 Document Type: Article Affiliation country: J.diagmicrobio.2021.115518

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