Results from the WHO external quality assessment for the respiratory syncytial virus pilot, 2016-17

Sandra Jackson, Teresa C.T. Peret, Thedi T. Ziegler, Natalie J. Thornburg, Terry Besselaar, Shobha Broor, Ian Barr, Elsa Baumeister, Mandeep Chadha, Malinee Chittaganpitch, Badarch Darmaa, Joanna Ellis, Rodrigo Fasce, Belinda Herring, Kadjo Herve, Siddhivinayak Hirve, Yan Li, Maria Pisareva, Ann Moen, Amel NaguibRakhee Palekar, Varsha Potdar, Marilda Siqueira, Florette Treurnicht, Almiro Tivane, Marietjie Venter, Niteen Wairagkar, Maria Zambon, Wenqing Zhang*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

Background: External quality assessments (EQAs) for the molecular detection of respiratory syncytial virus (RSV) are necessary to ensure the provision of reliable and accurate results. One of the objectives of the pilot of the World Health Organization (WHO) Global RSV Surveillance, 2016-2017, was to evaluate and standardize RSV molecular tests used by participating countries. This paper describes the first WHO RSV EQA for the molecular detection of RSV. Methods: The WHO implemented the pilot of Global RSV Surveillance based on the WHO Global Influenza Surveillance and Response System (GISRS) from 2016 to 2018 in 14 countries. To ensure standardization of tests, 13 participating laboratories were required to complete a 12 panel RSV EQA prepared and distributed by the Centers for Disease Control and Prevention (CDC), USA. The 14th laboratory joined the pilot late and participated in a separate EQA. Laboratories evaluated a RSV rRT-PCR assay developed by CDC and compared where applicable, other Laboratory Developed Tests (LDTs) or commercial assays already in use at their laboratories. Results: Laboratories performed well using the CDC RSV rRT-PCR in comparison with LDTs and commercial assays. Using the CDC assay, 11 of 13 laboratories reported correct results. Two laboratories each reported one false-positive finding. Of the laboratories using LDTs or commercial assays, results as assessed by Ct values were 100% correct for 1/5 (20%). With corrective actions, all laboratories achieved satisfactory outputs. Conclusions: These findings indicate that reliable results can be expected from this pilot. Continued participation in EQAs for the molecular detection of RSV is recommended.

Original languageEnglish
Pages (from-to)671-677
Number of pages7
JournalInfluenza and other Respiratory Viruses
Volume14
Issue number6
DOIs
Publication statusPublished - 1 Nov 2020

Bibliographical note

Funding Information:
The WHO Global RSV Surveillance pilot project was supported by an award made to the World Health Organization by the Bill and Melinda Gates Foundation (grant no. OPP1127419) with additional support from the Respiratory Viruses Branch, Division of Viral Diseases, CDC, Atlanta, and the CDC International Reagent Resource (IRR), USA. The authors would like to thank Brett L. Whitaker and Senthil Kumar K. Sakthivel (Respiratory Viruses Branch) for the technical help during the development, manufacturing, and shipping of the CDC RSV 2016 EQA panel.

Funding Information:
The WHO Global RSV Surveillance pilot was supported by an award made to the World Health Organization by the Bill and Melinda Gates Foundation (grant no. OPP1127419). The WHO Global RSV Surveillance pilot project was supported by an award made to the World Health Organization by the Bill and Melinda Gates Foundation (grant no. OPP1127419) with additional support from the Respiratory Viruses Branch, Division of Viral Diseases, CDC, Atlanta, and the CDC International Reagent Resource (IRR), USA. The authors would like to thank Brett L. Whitaker and Senthil Kumar K. Sakthivel (Respiratory Viruses Branch) for the technical help during the development, manufacturing, and shipping of the CDC RSV 2016 EQA panel. We are grateful to the national and international experts who participated in the informal consultations in March 2015, February 2016, and June 2016 that led to the strategy for development of the WHO RSV EQA. We acknowledge National Influenza Centres, Public Health Laboratories, and the Ministries of Health of pilot countries for participating in the WHO RSV EQA 2016. We thank colleagues in the Global Influenza Program, Influenza Preparedness and Response, Dept. of Infectious Hazards Management of the WHO Health Emergencies for supporting this work.

Funding Information:
The WHO Global RSV Surveillance pilot was supported by an award made to the World Health Organization by the Bill and Melinda Gates Foundation (grant no. OPP1127419).

Publisher Copyright:
© 2020 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Keywords

  • RSV external quality assessment
  • polymerase chain reaction
  • respiratory syncytial viruses

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