COVID-19 Diagnostics

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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

 

Project IDTitlePublication of Final ReviewAuthorCo-AuthorPublication of Project Plan
RCROT01*Rapid Collaborative Review on the role of antibody tests for novel coronavirus SARS-CoV-2 in the management of the current pandemic23.06.2020RERIQWiG, HTW12.05.2020
RCROT02Diagnostic accuracy of molecular methods that detect the presence of SARS-CoV-2 virus in people with suspected COVID-1904.12.2020 (revised 14.12.2020)HTWHIS, Austrian Social Insurance – Dachverband der Sozialversicherungsträger (formerly HVB)31.07.2020 (revised 08.10.2020)

*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

 

CountryOrganisationDate of publicationHTA reviews/assessments on Covid testing
UKNICE
n.d.Evidence standards framework for SARS-CoV-2 and anti-SARS-CoV-2 antibody diagnostic tests
NorwayNIPHNO (formerly NOKC)
n.d.NIPH systematic and living map on COVID-19 evidence (including lab tests)
IrelandHIQA
10/21/20Rapid 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)
FranceHAS
10/08/20Revue rapide sur les tests de détection antigénique du virus SARS-CoV-2
PortugalINFARMED National Authority of Medicines and Health Products 7/1/20Informação adicional para utilização do teste "GeneFinder COVID-19 Plus RealAmp Kit" (Additional information for using the "GeneFinder COVID-19 Plus RealAmp) Kit" test)
PortugalINFARMED National Authority of Medicines and Health Products 7/1/20Comercialização 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")
SpainDGFPS MSPSI
Directorate General for Pharmacy and Health Care Products
s
6/30/20Instrucciones 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)
SpainAVALIA FNS
Fundacion Profesor Novoa Santos
6/29/20Estudios seleccionados sobre SARS-CoV-2 y COVID-19 (Selected studies on SARS-CoV-2)
FinlandTHL National Institute for Health and Welfare6/26/20Koronaviruksen 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))
IrelandHIQA
Health Information and Quality Authority

6/23/20Evidence summary for salivary detection of SARS-CoV-2
SpainAVALIA-T
Galician Agency for HTA

6/19/20Estudios seleccionados sobre SARS-CoV-2 y COVID-19, Categoría: Diagnósticos (Selected studies on SARS-CoV-2 and COVID-19, Category: Diagnostics)
PortugalINFARMED
National Authority of Medicines and Health Products

6/12/20Retificação - 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)
SpainAETS-ISCIII
The Instituto De Salud Carlos III

6/1/20Deteccion 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)
NorwayNIPHNO (formerly NOKC)
The Norwegian Institute of Public Health

5/31/20Saliva sampling for testing SARS-CoV-2 infection - a rapid review
NorwayNIPHNO (formerly NOKC)
The Norwegian Institute of Public Health

5/29/20Serology and rapid tests
PortugalINFARMED
National Authority of Medicines and Health Products

5/28/20Testes laboratoriais para SARS-CoV-2, Testes Rápidos (Laboratory tests for SARS-CoV-2, Rapid Tests)
PortugalDGS / INFARMED / INSA Joint Information
5/27/20Testes Laboratoriais para SARS-CoV-2; Testes Rápidos (Laboratory Tests for SARS-CoV-2; Rapid Tests, Joint information)
SpainAETS-ISCIII
The Instituto De Salud Carlos III

5/24/20Interpretación de las pruebas diagnósticas frente a SARS-CoV-2 (Interpretation of diagnostic evidence against SARS-CoV-2)
NorwayNIPHNO (formerly NOKC)
The Norwegian Institute of Public Health

5/22/20Molecular diagnostics of sars-Cov-2
SpainAETSA
Andalusian HTA Agency

5/21/20Exactitud 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)
FranceHAS5/20/20Avis 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)
SlovakiaMoH Slovak Republic
Ministry of Health of the Slovak Republic

5/19/20Klinický 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)
SpainDGFPS MSPSI
Directorate General for Pharmacy and Health Care Products
s

5/18/20Toma y transporte de muestras para diagnóstico por PCR de SARS-CoV-2 (Guide for taking and transporting samples for SARS-CoV-2 PCR diagnosis)
HungaryNIPN
National Institute of Pharmacy and Nutrition

5/15/20Tájékoztatás 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)
FranceHAS5/14/20Avis 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)
UKAWTTC
All Wales Therapeutics and Toxicology Centre

5/14/20The clinical effectiveness of tests to detect the presence of SARS-CoV-2 virus, and antibodies to SARS-CoV-2, to inform COVID-19 diagnosis
PortugalINFARMED
National Authority of Medicines and Health Products

5/11/20Falsificação de testes rápidos para COVID-19 (Counterfeit rapid tests for COVID-19)
SpainAETS-ISCIII
The Instituto De Salud Carlos III

5/7/20Guía para la utilización de tests rápidos de anticuerpos para covid-19 (Guide to the use of quick tests of antibodies for covid-19)
FranceHAS5/6/20Avis 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)
IrelandHIQA
Health Information and Quality Authority

5/5/20Rapid HTA of alternative diagnostic testing for coronavirus 2 (SARS-CoV-2)
FranceHAS5/2/20Place 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)
PolandAOTMiT
Agency for Health Technology Assessment and Tariff System
4/25/20COVID-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
SlovakiaMoH Slovak Republic Ministry of Health of the Slovak Republic4/25/20Štandardný 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)
PortugalACSS IP
Administração Central do Sistema de Saúde, I.P.

4/24/20COVID-19: Diagnóstico Laboratorial (COVID-19: Laboratory Diagnosis)
PolandAOTMiT
Agency for Health Technology Assessment and Tariff System

4/21/20Analiza kosztów wykonania testów na obecność wirusa SARS-CoV-2 (Analysis of the costs of testing for the presence of SARS-CoV-2 virus)
ItalyRER
Regione Emilia-Romagna
4/16/20Covid-19: Disciplina die test sierologici (Serological test discipline)
SlovakiaMoH Slovak Republic Ministry of Health of the Slovak Republic 4/15/20Štandardný 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)
IrelandHIQA Health Information and Quality Authority4/15/20Evidence Summary for COVID-19 Clinical Samples
NorwayHdir Norwegian Directorate of Health4/14/20Hvordan øke testkapasiteten for SARS-CoV-2 i Norge? (How to increase the test capacity for SARS-CoV-2 in Norway?)
ItalyDGFDM IT
Sede del Ministro – Ministero della salute
4/3/20VALidation of SARS-CORona Virus-2 assays - VALCOR project (End of project: 30.09.2021)
BelgiumIPH - Scientific Institute of Public Health (sciensano)4/1/20VALidation of SARS-CORona Virus-2 assays - VALCOR project (End of project: 30.09.2021)
SwedenMPA Medical Products Agency4/1/20Snabb- och självtester för covid-19 (Quick and self tests for covid-19)
CroatiaMIZ
Ministry of Health of the Republic of Croatia
3/31/20Uzimanje uzoraka za testiranje na SARS-CoV-2 (Sampling for testing on SARS-CoV-2 - Instructions)
NorwayHdir 3/28/20Testkapasitet 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