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Molecular diagnostics of SARS-CoV-2: Findings of an international survey.
Vacaflores Salinas, Aldo; Ashavaid, Tester; Payne, Deborah A; Linder, Mark W; Baluchova, Katarina; Pan, Shiyang; Huggett, Jim; Ahmad-Nejad, Parviz.
  • Vacaflores Salinas A; Plexus Laboratorio, La Paz, Bolivia.
  • Ashavaid T; Department of Laboratory Medicine, P.D. Hinduja National Hospital and Medical Research Center, Mumbai, India.
  • Payne DA; CPDP Consulting, LLC, Denver, CO, USA.
  • Linder MW; Department of Pathology and Laboratory Medicine, University of Louisville School of Medicine, Louisville, KY USA.
  • Baluchova K; LABCON-OWL Analytics, Research and Consulting GmbH, Bad Salzuflen, Germany.
  • Pan S; The Department of Laboratory Medicine of the First Affiliated Hospital of Nanjing Medical University, China.
  • Huggett J; National Measurement Laboratory (NML) at LGC, Queens Rd, Teddington TW11 0LY, United Kingdom; School of Biosciences & Medicine, Faculty of Health & Medical Science, University of Surrey, Guildford GU2 7XH, United Kingdom.
  • Ahmad-Nejad P; Institute for Medical Laboratory Diagnostics, Helios University Hospital, Witten/Herdecke University, Germany. Electronic address: parviz.ahmad-nejad@helios-gesundheit.de.
Clin Chim Acta ; 531: 237-242, 2022 Jun 01.
Article in English | MEDLINE | ID: covidwho-1778016
ABSTRACT

BACKGROUND:

In the current COVID-19 pandemic, early and rapid diagnosis of potentially infected and contagious individuals enables containment of the disease through quarantine and contact tracing. The rapid global expansion of these diagnostic testing services raises questions concerning the current state of the art with regard to standardization of testing and quality assessment practices. The aim of this study was to provide a global overview of the test methods, laboratory procedures and quality assessment practices used for SARS-CoV-2 diagnostics.

METHODS:

The Molecular Diagnostics Committee of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC C-MD) initiated a survey among international laboratories performing molecular genetic detection of SARS-CoV-2. Questions on quality assurance, variant testing, sequencing and the transmission of findings were included in the survey.

RESULTS:

A total of 273 laboratories from 49 countries participated in the survey. The majority of the participating laboratories (92.2%) use reverse transcriptase polymerase chain reaction (RT-PCR). The majority of participating laboratories do not conduct testing to identify SARS CoV-2 variants. Participation in external quality assessment programs was reported by the majority of laboratories, however, 33.2% of the laboratories reported not participating in external quality assurance programmes.

CONCLUSIONS:

Based on the survey, molecular diagnostic methods for SARS-CoV-2 detection are clearly not standardized across different countries and laboratories. The survey found an array of responses in regard to sample preparation, collection, processing and reporting of results. This work suggests quality assurance is insufficiently performed by diagnostic laboratories conducting SARS-CoV-2 testing.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Topics: Variants Limits: Humans Language: English Journal: Clin Chim Acta Year: 2022 Document Type: Article Affiliation country: J.cca.2022.04.007

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Observational study / Prognostic study Topics: Variants Limits: Humans Language: English Journal: Clin Chim Acta Year: 2022 Document Type: Article Affiliation country: J.cca.2022.04.007