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Evaluation of GENECUBE(R) HQ SARS-CoV-2 for anterior nasal samples and saliva samples with a new rapid examination protocol
Preprint
in English
| medRxiv
| ID: ppmedrxiv-21262454
ABSTRACT
IntroductionGENECUBE(R) is a rapid molecular identification system, and previous studies demonstrated that GENECUBE(R) HQ SARS-CoV-2 showed excellent analytical performance for the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) with nasopharyngeal samples. However, other respiratory samples have not been evaluated. MethodsThis prospective comparison between GENECUBE(R) HQ SARS-CoV-2 and reference real-time reverse transcriptase polymerase chain reaction (RT-PCR) was performed for the detection of SARS-CoV-2 using anterior nasal samples and saliva samples. Additionally, we evaluated a new rapid examination protocol using GENECUBE(R) HQ SARS-CoV-2 for the detection of SARS-CoV-2 with saliva samples. For the rapid protocol, in the preparation of saliva samples, purification and extraction processes were adjusted, and the total process time was shortened to approximately 35 minutes. ResultsFor 359 anterior nasal samples, the total-, positive-, and negative concordance of the two assays was 99.7% (358/359), 98.1% (51/52), and 100% (307/307), respectively. For saliva samples, the total-, positive-, and negative concordance of the two assays was 99.6% (239/240), 100% (56/56), and 99.5% (183/184), respectively. With the new protocol, total-, positive-, and negative concordance of the two assays was 98.8% (237/240), 100% (56/56), and 98.4% (181/184), respectively. In all discordance cases, SARS-CoV-2 was detected by additional molecular examinations. ConclusionGENECUBE(R) HQ SARS-CoV-2 provided high analytical performance for the detection of SARS-CoV-2 in anterior nasal samples and saliva samples.
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Full text:
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Collection:
Preprints
Database:
medRxiv
Type of study:
Experimental_studies
/
Observational study
/
Prognostic study
Language:
English
Year:
2021
Document type:
Preprint