Dataset Information

First international external quality assessment of molecular diagnostics for Mers-CoV.

ABSTRACT:

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.

SUBMITTER: Pas SD

PROVIDER: S-EPMC7106520 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Publications

First international external quality assessment of molecular diagnostics for Mers-CoV.

Pas Suzan D SD Patel Pranav P Reusken Chantal C Domingo Cristina C Corman Victor M VM Drosten Christian C Dijkman Ronald R Thiel Volker V Nowotny Norbert N Koopmans Marion P G MP Niedrig Matthias M

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 20150530

<h4>Background</h4>Since the discovery of Middle East respiratory syndrome coronavirus (MERS-CoV) in 2012, diagnostic protocols were quickly published and deployed globally.<h4>Objectives</h4>We set out to assess the quality of MERS-CoV molecular diagnostics worldwide.<h4>Study design</h4>Both sensitivity and specificity were assessed using 12 samples containing different viral loads of MERS-CoV or common coronaviruses (OC43, 229E, NL63, HKU1).<h4>Results</h4>The panel was sent to more than 106 ...[more]

PMID: 26209385

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Project description:BACKGROUND: Currently dengue viruses (DENV) pose an increasing threat to over 2.5 billion people in over 100 tropical and sub-tropical countries worldwide. International air travel is facilitating rapid global movement of DENV, increasing the risk of severe dengue epidemics by introducing different serotypes. Accurate diagnosis is critical for early initiation of preventive measures. Different reverse transcriptase PCR (RT-PCR) methods are available, which should be evaluated and standardized. Epidemiological and laboratory-based surveillance is required to monitor and guide dengue prevention and control programmes, i.e., by mosquito control or possible vaccination (as soon as an effective and safe vaccine becomes available). OBJECTIVE: The purpose of the external quality assurance (EQA) study described is to assess the efficiency and accuracy of dengue molecular diagnosis methods applied by expert laboratories. STUDY DESIGN: A panel of 12 human plasma samples was distributed and tested for DENV-specific RNA. The panel comprised 9 samples spiked with different DENV serotypes (DENV-1 to DENV-4), including 10-fold dilution series of DENV-1 and DENV-3. Two specificity controls consisted of a sample with a pool of 4 other flaviviruses and a sample with chikungunya virus. A negative control sample was also included. RESULTS: Thirty-seven laboratories (from Europe, Middle East Asia, Asia, the Americas/Caribbean, and Africa) participated in this EQA study, and reports including 46 sets of results were returned. Performance among laboratories varied according to methodologies used. Only 5 (10.9%) data sets met all criteria with optimal performance, and 4 (8.7%) with acceptable performance, while 37 (80.4%) reported results showed the need for improvement regarding accomplishment of dengue molecular diagnosis. Failures were mainly due to lack of sensitivity and the presence of false positives. CONCLUSIONS: The EQA provides information on each laboratory's efficacy of RT-PCR techniques for dengue diagnosis and indicates for most laboratories an urgent need to improve sensitivity and specificity.

Dataset Information

First international external quality assessment of molecular diagnostics for Mers-CoV.

Background

Objectives

Study design

Results

Conclusions

Publications

First international external quality assessment of molecular diagnostics for Mers-CoV.

Similar Datasets

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