Laboratory verification of an RT-PCR assay for SARS-CoV-2.
J Clin Lab Anal
; 34(10): e23507, 2020 Oct.
Article
in English
| MEDLINE | ID: covidwho-700318
ABSTRACT
BACKGROUND:
Reverse transcription-polymerase chain reaction (RT-PCR) is an extremely common clinical method for detecting pathogens, particularly for emerging infectious diseases such as the new coronavirus disease (COVID-19). Currently, detection of the RNA from the novel coronavirus SARS-CoV-2 is the gold standard for establishing a COVID-19 diagnosis. This study evaluates the characteristic performance of the analytical system in a clinical laboratory.METHODS:
A commercial SARS-CoV-2 RNA RT-PCR Kit used in a clinical laboratory is assessed based on ISO 15189 verification requirements. A multiple real-time RT-PCR assay for the RdRP, N, and E genes in SARS-CoV-2 is verified.RESULTS:
The analytical system exhibits good analytical sensitivity (1000 copies/mL) and specificity (100%); however, the values of 86.7% and 100% for analytical accuracy deserved attention, compared with two other types of methods. Overall, the kit is potentially useful for SARS-CoV-2 diagnostic testing and meets the verification requirements.CONCLUSION:
Compliance with international standards, such as ISO 15189, is valuable for clinical laboratories and for improving laboratory medicine quality and safety. Normalization is essential for obtaining reliable results from the SARS-CoV-2 RNA RT-PCR assay. This study aims to develop an improved SARS-CoV-2 verification framework compared with traditional molecular diagnostic methods, given the urgency of implementing new assays in clinical laboratories.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Coronavirus Infections
/
Clinical Laboratory Techniques
/
Reverse Transcriptase Polymerase Chain Reaction
/
Molecular Diagnostic Techniques
/
Betacoronavirus
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
J Clin Lab Anal
Journal subject:
Laboratory Techniques and procedures
Year:
2020
Document Type:
Article
Affiliation country:
Jcla.23507
Similar
MEDLINE
...
LILACS
LIS