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2020 ; 129
(ä): 104427
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Comparison of a laboratory-developed test targeting the envelope gene with three
nucleic acid amplification tests for detection of SARS-CoV-2
#MMPMID32535398
Bulterys PL
; Garamani N
; Stevens B
; Sahoo MK
; Huang C
; Hogan CA
; Zehnder J
; Pinsky BA
J Clin Virol
2020[Aug]; 129
(ä): 104427
PMID32535398
show ga
BACKGROUND: Numerous nucleic acid amplification tests, including real-time,
reverse transcription PCR (rRT-PCR) and isothermal amplification methods, have
been developed to detect SARS-CoV-2 RNA, including many that have received
emergency use authorization (EUA). There is a need to assess their test
performance relative to one another. OBJECTIVES: The aim of this study was to
compare the test performance of a high complexity laboratory-developed rRT-PCR
EUA from Stanford Health Care (SHC) targeting the SARS-CoV-2 envelope (E) gene
with other tests: the Atila isothermal amplification assay targeting the
nucleocapsid (N) gene and open reading frame 1ab (ORF1ab), the Altona E and spike
(S) multiplex, real-time RT-PCR, and the US Centers for Disease Control and
Prevention (CDC) N1 and N2 rRT-PCRs. STUDY DESIGN: A diagnostic comparison study
was performed by testing nasopharyngeal samples from persons under investigation
for coronavirus disease 2019 (COVID-19). Assay performance was assessed by
percent agreement and Cohen's kappa coefficient. RESULTS: Positive percent
agreement with the SHC EUA reference assay was 82.8 % (95 % confidence interval
(CI) 65.0 to 92.9) for Atila, 86.7 % (95 % CI 69.7 to 95.3) for the Altona E and
S targets, and 86.7 % (95 % CI 69.7 to 95.3) and 90.0 % (95 % CI 73.6 to 97.3),
for the CDC N1 and N2 targets, respectively. All assays demonstrated 100 %
negative percent agreement. Kappa coefficients ranged from 0.86 to 0.92,
indicating excellent agreement. CONCLUSIONS: Performance was comparable among the
SARS-CoV-2 nucleic acid amplification methods tested, with a limited number of
discrepancies observed in specimens with low viral loads.