TY - JOUR
T1 - First international external quality assessment of molecular diagnostics for Mers-CoV
AU - Pas, Suzan D.
AU - Patel, Pranav
AU - Reusken, Chantal
AU - Domingo, Cristina
AU - Corman, Victor M.
AU - Drosten, Christian
AU - Dijkman, Ronald
AU - Thiel, Volker
AU - Nowotny, Norbert
AU - Koopmans, Marion P.G.
AU - Niedrig, Matthias
N1 - Publisher Copyright:
© 2015 The Authors.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - Background: Since the discovery of Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, diagnostic protocols were quickly published and deployed globally. Objectives: We set out to assess the quality of MERS-CoV molecular diagnostics worldwide. Study design: Both sensitivity and specificity were assessed using 12 samples containing different viral loads of MERS-CoV or common coronaviruses (OC43, 229E, NL63, HKU1). Results: The panel was sent to more than 106 participants, of which 99 laboratories from 6 continents returned 189 panel results. Scores ranged from 100% (84 laboratories) to 33% (1 laboratory). 15% of respondents reported quantitative results, 61% semi-quantitative (Ct-values or time to positivity) and 24% reported qualitative results. The major specific technique used was real-time RT-PCR using the WHO recommended targets upE, ORF1a and ORF1b. The evaluation confirmed that RT-PCRs targeting the ORF1b are less sensitive, and therefore not advised for primary diagnostics. Conclusions: The first external quality assessment MERS-CoV panel gives a good insight in molecular diagnostic techniques and their performances for sensitive and specific detection of MERS-CoV RNA globally. Overall, all laboratories were capable of detecting MERS-CoV with some differences in sensitivity. The observation that 8% of laboratories reported false MERS-CoV positive single assay results shows room for improvement, and the importance of using confirmatory targets.
AB - Background: Since the discovery of Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, diagnostic protocols were quickly published and deployed globally. Objectives: We set out to assess the quality of MERS-CoV molecular diagnostics worldwide. Study design: Both sensitivity and specificity were assessed using 12 samples containing different viral loads of MERS-CoV or common coronaviruses (OC43, 229E, NL63, HKU1). Results: The panel was sent to more than 106 participants, of which 99 laboratories from 6 continents returned 189 panel results. Scores ranged from 100% (84 laboratories) to 33% (1 laboratory). 15% of respondents reported quantitative results, 61% semi-quantitative (Ct-values or time to positivity) and 24% reported qualitative results. The major specific technique used was real-time RT-PCR using the WHO recommended targets upE, ORF1a and ORF1b. The evaluation confirmed that RT-PCRs targeting the ORF1b are less sensitive, and therefore not advised for primary diagnostics. Conclusions: The first external quality assessment MERS-CoV panel gives a good insight in molecular diagnostic techniques and their performances for sensitive and specific detection of MERS-CoV RNA globally. Overall, all laboratories were capable of detecting MERS-CoV with some differences in sensitivity. The observation that 8% of laboratories reported false MERS-CoV positive single assay results shows room for improvement, and the importance of using confirmatory targets.
KW - Diagnosis
KW - EQA
KW - MERS-CoV
KW - Molecular
KW - QPCR
KW - Quality control
KW - Real-time RT-PCR
KW - Viral load
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U2 - 10.1016/j.jcv.2015.05.022
DO - 10.1016/j.jcv.2015.05.022
M3 - Article
C2 - 26209385
AN - SCOPUS:84937905701
SN - 1386-6532
VL - 69
SP - 81
EP - 85
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
ER -