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.