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
Belgium
IPH – Scientific Institute of Public Health (sciensano)
4/1/20
VALidation of SARS-CORona Virus-2 assays – VALCOR project (End of project: 30.09.2021)
Croatia
MIZ Ministry of Health of the Republic of Croatia
3/31/20
Uzimanje uzoraka za testiranje na SARS-CoV-2 (Sampling for testing on SARS-CoV-2 – Instructions)
Finland
THL National Institute for Health and Welfare
6/26/20
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))
France
HAS
10/08/20
Revue rapide sur les tests de détection antigénique du virus SARS-CoV-2
France
HAS
5/20/20
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)
France
HAS
5/14/20
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)
France
HAS
5/6/20
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)
France
HAS
5/2/20
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)
Hungary
NIPN National Institute of Pharmacy and Nutrition
5/15/20
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)
Ireland
HIQA
10/21/20
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)
Ireland
HIQA Health Information and Quality Authority
6/23/20
Evidence summary for salivary detection of SARS-CoV-2
Ireland
HIQA Health Information and Quality Authority
5/5/20
Rapid HTA of alternative diagnostic testing for coronavirus 2 (SARS-CoV-2)
Ireland
HIQA Health Information and Quality Authority
4/15/20
Evidence Summary for COVID-19 Clinical Samples
Italy
RER Regione Emilia-Romagna
4/16/20
Covid-19: Disciplina die test sierologici (Serological test discipline)
Italy
DGFDM IT Sede del Ministro – Ministero della salute
4/3/20
VALidation of SARS-CORona Virus-2 assays – VALCOR project (End of project: 30.09.2021)
Norway
NIPHNO (formerly NOKC)
n.d.
NIPH systematic and living map on COVID-19 evidence (including lab tests)
Norway
NIPHNO (formerly NOKC) The Norwegian Institute of Public Health
5/31/20
Saliva sampling for testing SARS-CoV-2 infection – a rapid review
Norway
NIPHNO (formerly NOKC) The Norwegian Institute of Public Health
5/29/20
Serology and rapid tests
Norway
NIPHNO (formerly NOKC) The Norwegian Institute of Public Health
5/22/20
Molecular diagnostics of sars-Cov-2
Norway
Hdir Norwegian Directorate of Health
4/14/20
Hvordan øke testkapasiteten for SARS-CoV-2 i Norge? (How to increase the test capacity for SARS-CoV-2 in Norway?)
Norway
Hdir
3/28/20
Testkapasitet for Covid-19 sykdom (Test capacity for Covid-19 disease)
Poland
AOTMiT Agency for Health Technology Assessment and Tariff System
4/25/20
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
Poland
AOTMiT Agency for Health Technology Assessment and Tariff System
4/21/20
Analiza kosztów wykonania testów na obecność wirusa SARS-CoV-2 (Analysis of the costs of testing for the presence of SARS-CoV-2 virus)
Portugal
INFARMED National Authority of Medicines and Health Products
7/1/20
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
7/1/20
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”)
Portugal
INFARMED National Authority of Medicines and Health Products
6/12/20
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)
Portugal
INFARMED National Authority of Medicines and Health Products
5/28/20
Testes laboratoriais para SARS-CoV-2, Testes Rápidos (Laboratory tests for SARS-CoV-2, Rapid Tests)
Portugal
DGS / INFARMED / INSA Joint Information
5/27/20
Testes Laboratoriais para SARS-CoV-2; Testes Rápidos (Laboratory Tests for SARS-CoV-2; Rapid Tests, Joint information)
Portugal
INFARMED National Authority of Medicines and Health Products
5/11/20
Falsificação de testes rápidos para COVID-19 (Counterfeit rapid tests for COVID-19)
Portugal
ACSS IP Administração Central do Sistema de Saúde, I.P.
4/24/20
COVID-19: Diagnóstico Laboratorial (COVID-19: Laboratory Diagnosis)
Slovakia
MoH Slovak Republic Ministry of Health of the Slovak Republic
5/19/20
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)
Slovakia
MoH Slovak Republic Ministry of Health of the Slovak Republic
4/25/20
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)
Slovakia
MoH Slovak Republic Ministry of Health of the Slovak Republic
4/15/20
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)
Spain
AETS-ISCIII The Instituto De Salud Carlos III
n.d.
INFORME CIENTÍFICO-DIVULGATIVO: UN AÑO DE CORONAVIRUS SARS-COV-2 ( SCIENTIFIC-DISCLOSURE REPORT: A YEAR OF CORONAVIRUS SARS-COV-2)
Spain
DGFPS MSPSI Directorate General for Pharmacy and Health Care Products
6/30/20
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
6/29/20
Estudios seleccionados sobre SARS-CoV-2 y COVID-19 (Selected studies on SARS-CoV-2)
Spain
AVALIA-T Galician Agency for HTA
6/19/20
Estudios seleccionados sobre SARS-CoV-2 y COVID-19, Categoría: Diagnósticos (Selected studies on SARS-CoV-2 and COVID-19, Category: Diagnostics)
Spain
AETS-ISCIII The Instituto De Salud Carlos III
6/1/20
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)
Spain
AETS-ISCIII The Instituto De Salud Carlos III
5/24/20
Interpretación de las pruebas diagnósticas frente a SARS-CoV-2 (Interpretation of diagnostic evidence against SARS-CoV-2)
Spain
AETSA Andalusian HTA Agency
5/21/20
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)
Spain
DGFPS MSPSI Directorate General for Pharmacy and Health Care Products
5/18/20
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)
Spain
AETS-ISCIII The Instituto De Salud Carlos III
5/7/20
Guía para la utilización de tests rápidos de anticuerpos para covid-19 (Guide to the use of quick tests of antibodies for covid-19)
Sweden
MPA Medical Products Agency
4/1/20
Snabb- och självtester för covid-19 (Quick and self tests for covid-19)
UK
NICEE
n.d.
Evidence standards framework for SARS-CoV-2 and anti-SARS-CoV-2 antibody diagnostic tests
UK
AWTTC All Wales Therapeutics and Toxicology Centre
5/14/20
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

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