Peadar Tóibín (Meath West, Aontú)
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652. To ask the Minister for Health if the analysis of PCR tests has changed in line with new WHO guidelines issued on 21 January 2021 (details supplied). [5187/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The World Health Organization (WHO) Information Notice for IVD Users 2020/05 published on 13 January 2021 clarifies information previously provided by WHO. It requests laboratory professionals and In Vitro Diagnostic Medical Device (IVD) users to follow the instructions for use (IFU) when interpreting results for specimens tested using PCR methodology and reiterates the advice the it is a feature of the PCR test that means the clinical context of the test must also be taken into account.

The HSE has adopted RNA PCR as the gold standard test for diagnosing Covid-19. This is consistent with international best practice. The World Health Organization (WHO) and the European Centre for Disease Prevention and Control (ECDC) recommend that nucleic acid amplification tests, such as rRT-PCR, should be used to detect suspected, active SARS-CoV-2 infection. Recently, for example, in its Technical Report “Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK”, published on 19 November 2020, the ECDC confirmed that “To date, testing for SARS-CoV-2 infection mostly relies on reverse transcription polymerase chain reaction (RT-PCR) performed on a nasopharyngeal specimen. This testing method remains the gold standard for detecting SARS-CoV-2 and is characterised by both high sensitivity and specificity in detecting viral ribonucleic acid (RNA).”

This position remains unchanged and the WHO Information Notice Simply reminds the professionals involved in the analysis of samples using the rRT-PCR to follow manufacturer instructions. SARS-CoV-2 PCR assays in Ireland in use by the HSE and laboratories operating on behalf of the HSE are operated in accordance with the manufacturers' instructions and the CE marking for the assay.