Comparative in Silico Design and Validation of GPS™ CoVID-19 Dtec-RT-qPCR Test

Overview

Journal J Appl Microbiol

Publisher Oxford University Press

Date 2020 Jul 12

PMID 32652813

Citations 5

Authors

A Martinez-Murcia

G Bru

A Navarro

P Ros-Tarraga

A Garcia-Sirera

L Perez

Affiliations

Soon will be listed here.

Abstract

Aims: Providing a ready-to-use reverse transcriptase qPCR (RT-qPCR) method fully validated to detect the SARS-CoV-2 with a higher exclusivity than this shown by early published RT-qPCR designs.

Methods And Results: The specificity of the GPS™ CoVID-19 dtec-RT-qPCR test by analysis of sequence alignments was approached and compared with other RT-qPCR designs. The GPS™ CoVID-19 dtec-RT-qPCR test was validated following criteria of UNE/EN ISO 17025:2005 and ISO/IEC 15189:2012. Diagnostic validation was achieved by two independent reference laboratories, the Instituto de Salud Carlos III, (Madrid, Spain), the Public Health England (Colindale, London, UK), and received the label CE-IVD. The GPS design showed the highest exclusivity and passed all parameters of validation with strict acceptance criteria. Results from reference laboratories 100% correlated with these obtained by using reference methods and showed 100% of diagnostic sensitivity and specificity.

Conclusions: The CE-IVD GPS™ CoVID-19 dtec-RT-qPCR test, available worldwide with full analytical and diagnostic validation, is the more exclusive for SARS-CoV-2 by far.

Significance And Impact Of The Study: Considering the CoVID-19 pandemic status, the exclusivity of RT-qPCR tests is crucial to avoid false positives due to related coronaviruses. This work provides of a highly specific and validated RT-qPCR method for detection of SARS-CoV-2, which represents a case of efficient transfer of technology successfully used since the pandemic was declared.

Citing Articles

Internal Validation of the ASFV MONODOSE dtec-qPCR Kit for African Swine Fever Virus Detection under the UNE-EN ISO/IEC 17025:2005 Criteria.

Bru G, Martinez-Candela M, Romero P, Navarro A, Martinez-Murcia A Vet Sci. 2023; 10(9).

PMID: 37756086 PMC: 10535882. DOI: 10.3390/vetsci10090564.

Internal Validation of a Real-Time qPCR Kit following the UNE/EN ISO/IEC 17025:2005 for Detection of the Re-Emerging .

Martinez-Murcia A, Navarro A, Garcia-Sirera A, Perez L, Bru G Diagnostics (Basel). 2023; 13(9).

PMID: 37174951 PMC: 10177549. DOI: 10.3390/diagnostics13091560.

SARS-CoV-2 Variants Identification; A Fast and Affordable Strategy Based on Partial S-Gene Targeted PCR Sequencing.

Martinez-Murcia A, Garcia-Sirera A, Navarro A, Perez L Viruses. 2022; 14(11).

PMID: 36423197 PMC: 9696215. DOI: 10.3390/v14112588.

Current RT-qPCR to detect SARS-CoV-2 may give positive results for related coronaviruses.

Martinez-Murcia A, Garcia-Sirera A, Navarro A, Perez L Arch Microbiol. 2022; 204(7):415.

PMID: 35737122 PMC: 9223264. DOI: 10.1007/s00203-022-03029-y.

A Comprehensive Overview of the COVID-19 Literature: Machine Learning-Based Bibliometric Analysis.

Abd-Alrazaq A, Schneider J, Mifsud B, Alam T, Househ M, Hamdi M J Med Internet Res. 2021; 23(3):e23703.

PMID: 33600346 PMC: 7942394. DOI: 10.2196/23703.

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