COVID-19 Diagnostics

COVID-19 Diagnostics

This section is dedicated to rapid collaborative reviews and HTA reports on diagnostic tests for the detection of SARS-CoV-2 requested to inform timely national policy/decision-making.

EUnetHTA Rapid Collaborative Reviews

*Note: Since the publication of this Rapid Collaborative Review on the 23rd June, several good quality systematic reviews addressing the question on diagnostic use of SARS-COV-2 antibody tests in asymptomatic and symptomatic patients have been published. These more recent reviews have confirmed our findings and the limitations of the screening and diagnostic use of these tests, due to how antibodies develop and the time it takes to become detectable. While the retrieved studies in our review showed antibody tests are “responsive” to be used in seroprevalence studies, the current knowledge on the natural history of the disease – namely virus clearance and immunity – is still too limited to allow investigation of a potential role of antibody tests in these intended uses.

In light of the above, the Assessment Team has agreed not to proceed with further updates of this review.

National HTA Organisation Diagnostics Reports

Country Organisation Date of publication HTA reviews/assessments on Covid testing
UK NICE n.d. Evidence standards framework for SARS-CoV-2 and anti-SARS-CoV-2 antibody diagnostic tests
Norway NIPHNO (formerly NOKC) n.d. NIPH systematic and living map on COVID-19 evidence (including lab tests)
Norway Hdir Norwegian Directorate of Health 05/03/21 Evaluering av utstyr for prøvetaking av spytt for diagnostisk analyse av SARS-CoV-2 RNA (Evaluation of equipment for sampling of saliva for diagnostic analysis of SARS-CoV-2 RNA)
France HAS 11/2/21 Méta-analyse de l’intérêt diagnostique des tests RT-PCR salivaires de détection du SARS-CoV-2 (Meta-analysis of the diagnostic value of salivary RT-PCR tests for the detection of SARS-CoV-2)
France HAS 04/12/20 Revue rapide sur les tests RT-PCR SARS-CoV-2 sur prélèvement salivaire (Rapid review of RT-PCR SARS-CoV-2 tests on saliva samples)
France HAS 04/12/20 Revue rapide sur les tests RT-LAMP sur prélèvement salivaire (hors système intégré de type EasyCoV) (Quick review of RT-LAMP tests on saliva samples (excluding integrated EasyCoV system))
Ireland HIQA 21/10/20 Rapid health technology assessment (HTA) of alternatives to laboratory- based real-time RT-PCR to diagnose current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
France HAS 10/08/20 Revue rapide sur les tests de détection antigénique du virus SARS-CoV-2
Portugal INFARMED National Authority of Medicines and Health Products 01/07/20 Informação adicional para utilização do teste “GeneFinder COVID-19 Plus RealAmp Kit” (Additional information for using the “GeneFinder COVID-19 Plus RealAmp) Kit” test)
Portugal INFARMED National Authority of Medicines and Health Products 01/07/20 Comercialização descontinuada do teste “BIOEASY 2019 – Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test” (Discontinued commercialization of the test “BIOEASY 2019 – Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test”)
Spain DGFPS MSPSI Directorate General for Pharmacy and Health Care Productss 30/06/20 Instrucciones sobre la realización de pruebas diagnósticas para la detección del Covid-19 en el ámbito de las empresas (Instructions on carrying out diagnostic tests for the detection of COVID-19 in companies)
Spain AVALIA FNS Fundacion Profesor Novoa Santos 29/06/20 Estudios seleccionados sobre SARS-CoV-2 y COVID-19 (Selected studies on SARS-CoV-2)
Finland THL National Institute for Health and Welfare 26/06/20 Koronaviruksen COVID-19 laboratoriotutkimukset – Mikrobiologiset tutkimukset uuden koronaviruksen (SARS-CoV-2) epäilyssäLaboratory studies of coronavirus COVID-19 (Microbiological studies on suspicion of a novel coronavirus (SARS-CoV-2))
Ireland HIQA Health Information and Quality Authority 23/06/20 Evidence summary for salivary detection of SARS-CoV-2
Spain AVALIA-T Galician Agency for HTA 19/06/20 Estudios seleccionados sobre SARS-CoV-2 y COVID-19, Categoría: Diagnósticos (Selected studies on SARS-CoV-2 and COVID-19, Category: Diagnostics)
Portugal INFARMED National Authority of Medicines and Health Products 12/06/20 Retificação – Recolha voluntária de lote do teste Tell Me Fast Rapid Diagnostic Test Coronavirus (COVID-19) IgG/IgM Antibody Test (S/P/WB) – fabricante Biocan Diagnostics Inc (Rectification – Voluntary batch collection of the Tell Me Fast Rapid Diagnostic Test Coronavirus)
Spain AETS-ISCIII The Instituto De Salud Carlos III 01/06/20 Deteccion de SARS-CoV-2 en aguas residuales como herramienta de vigilancia y alerta rápida (detection of SARS-CoV-2 in wastewater as a surveillance tool and quick alert)
Norway NIPHNO (formerly NOKC) The Norwegian Institute of Public Health 31/05/20 Saliva sampling for testing SARS-CoV-2 infection – a rapid review
Norway NIPHNO (formerly NOKC) The Norwegian Institute of Public Health 29/05/20 Serology and rapid tests
Portugal INFARMED National Authority of Medicines and Health Products 28/05/20 Testes laboratoriais para SARS-CoV-2, Testes Rápidos (Laboratory tests for SARS-CoV-2, Rapid Tests)
Portugal DGS / INFARMED / INSA Joint Information 27/05/20 Testes Laboratoriais para SARS-CoV-2; Testes Rápidos (Laboratory Tests for SARS-CoV-2; Rapid Tests,  Joint information)
Spain AETS-ISCIII The Instituto De Salud Carlos III 24/05/20 Interpretación de las pruebas diagnósticas frente a SARS-CoV-2 (Interpretation of diagnostic evidence against SARS-CoV-2)
Norway NIPHNO (formerly NOKC) The Norwegian Institute of Public Health 22/05/20 Molecular diagnostics of sars-Cov-2
Spain AETSA Andalusian HTA Agency 21/05/20 Exactitud diagnóstica de la muestra de saliva para la detección de SARS-CoV-2. NIPH (Saliva sample for testing SARS-CoV-2 infection – a rapid review)
France HAS 20/05/20 Avis n° 2020.0033/AC/SEAP du 20 mai 2020 du collège de la Haute Autorité de santé relatif à l’inscription sur la liste des actes et prestations mentionnée à l’article L. 162-1-7 du code de la sécurité sociale, de la détection des anticorps sériques dirigés contre le coronavirus SARS-CoV-2 (Opinion of the college of the HAS relating to the inscription on the list of acts and services mentioned in article L. 162-1-7 of the social security code , detection of serum antibodies against SARS-CoV-2 coronavirus)
Slovakia MoH Slovak Republic Ministry of Health of the Slovak Republic 19/05/20 Klinický protokol indikácií testovania metódou PCR na dôkaz SARS-CoV-2 (verzia 9 dátum: 19.5.2020) (Clinical protocol for indications for PCR testing for SARS-CoV-2)
Spain DGFPS MSPSI Directorate General for Pharmacy and Health Care Productss 18/05/20 Toma y transporte de muestras para diagnóstico por PCR de SARS-CoV-2 (Guide for taking and transporting samples for SARS-CoV-2 PCR diagnosis)
Hungary NIPN National Institute of Pharmacy and Nutrition 15/05/20 Tájékoztatás SARS-CoV-2 (COVID-19) fertőzöttség kimutatására szánt gyorstesztekről és az önellenőrzési, laikusok általi (otthoni) tesztelési célra forgalomba hozható tesztek forgalmazásának és a kereskedelmi kommunikáció jogszerűségének egyes kérdéseiről (Information on rapid tests for the detection of SARS-CoV-2 (COVID-19) infection and on certain issues concerning the marketing of self-monitoring tests that can be placed on the market for lay (home) testing and the legality of commercial communications)
France HAS 14/05/20 Avis n° 2020.0032/AC/SBPP du 14 mai 2020 du collège de la Haute Autorité de santé portant sur les modalités de dépistage du virus SARS-CoV-2 chez les patients admis en établissement de santé (Opinion of the college of the HAS relating to the methods of detection of the virus SARS-CoV-2 in the patients admitted in health establishment)
UK AWTTC All Wales Therapeutics and Toxicology Centre 14/05/20 The clinical effectiveness of tests to detect the presence of SARS-CoV-2 virus, and antibodies to SARS-CoV-2, to inform COVID-19 diagnosis
Portugal INFARMED National Authority of Medicines and Health Products 11/05/20 Falsificação de testes rápidos para COVID-19 (Counterfeit rapid tests for COVID-19)
Spain AETS-ISCIII The Instituto De Salud Carlos III 07/05/20 Guía para la utilización de tests rápidos de anticuerpos para covid-19 (Guide to the use of quick tests of antibodies for covid-19)
France HAS 06/05/20 Avis n°2020.0020/AC/SEAP du 6 mars 2020 du collège de la HAS relatif à l’inscription sur la LAP mentionnée à l’article L. 162-1-7 du CSS, de la détection du génome du coronavirus SARS-CoV-2 par technique de transcription inverse suivie d’une amplification (Opinion of the college of the HAS relating to the registration on the LAP mentioned in article L. 162-1-7 of the CSS, of the detection of the genome of the coronavirus SARS-CoV -2 by reverse transcription technique followed by amplification)
Ireland HIQA Health Information and Quality Authority 05/05/20 Rapid HTA of alternative diagnostic testing for coronavirus 2 (SARS-CoV-2)
France HAS 02/05/20 Place des tests sérologiques dans la stratégie de prise en charge de la maladie COVID-19 (Place of serological tests in the COVID-19 management strategy)
Poland AOTMiT Agency for Health Technology Assessment and Tariff System 25/04/20 COVID-19 recommendations: Polish diagnostic, therapeutic and organisational recommendations for the care of individuals infected with SARS-CoV-2 or exposed to a SARS-CoV-2 infection
Slovakia MoH Slovak Republic Ministry of Health of the Slovak Republic 25/04/20 Štandardný postup pre mikrobiologickú diagnostiku pri suspektnej infekcii vírusom SARS-CoV2 pre laboratóriá klinickej mikrobiológie (Standard Procedure for Microbiological Diagnosis of Suspected SARS-CoV2 Virus Infection for Clinical Microbiology Laboratories)
Portugal ACSS IP Administração Central do Sistema de Saúde, I.P. 24/04/20 COVID-19: Diagnóstico Laboratorial (COVID-19: Laboratory Diagnosis)
Poland AOTMiT Agency for Health Technology Assessment and Tariff System 21/04/20 Analiza kosztów wykonania testów na obecność wirusa SARS-CoV-2 (Analysis of the costs of testing for the presence of SARS-CoV-2 virus)
Italy RER Regione Emilia-Romagna 16/04/20 Covid-19: Disciplina die test sierologici (Serological test discipline)
Slovakia MoH Slovak Republic Ministry of Health of the Slovak Republic 15/04/20 Štandardný preventívny, diagnostický a terapeutický postup pri starostlivosti o kriticky chorých s COVID-19 (Standard preventive, diagnostic and therapeutic procedure for the care of critically ill patients with COVID-19)
Ireland HIQA Health Information and Quality Authority 15/04/20 Evidence Summary for COVID-19 Clinical Samples
Norway Hdir Norwegian Directorate of Health 14/04/20 Hvordan øke testkapasiteten for SARS-CoV-2 i Norge? (How to increase the test capacity for SARS-CoV-2 in Norway?)
Italy DGFDM IT Sede del Ministro – Ministero della salute 03/04/20 VALidation of SARS-CORona Virus-2 assays – VALCOR project (End of project: 30.09.2021)
Belgium IPH – Scientific Institute of Public Health (sciensano) 01/04/20 VALidation of SARS-CORona Virus-2 assays – VALCOR project (End of project: 30.09.2021)
Sweden MPA Medical Products Agency 01/04/20 Snabb- och självtester för covid-19 (Quick and self tests for covid-19)
Croatia MIZ Ministry of Health of the Republic of Croatia 31/03/20 Uzimanje uzoraka za testiranje na SARS-CoV-2 (Sampling for testing on SARS-CoV-2 – Instructions)
Norway Hdir 28/03/20 Testkapasitet for Covid-19 sykdom (Test capacity for Covid-19 disease)

This will be a ‘work in progress’ as we accrue data and as the response to Covid-19 evolves, so please bookmark this page for quick reference as we build out the links.

For any questions, please contact the EUnetHTA Secretariat at eunethta@zinl.nl