Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans

To view all of WHO’s country and technical guidance on COVID-19 please visit our publications hub

Overview

On this page you will find information about:

  1. WHO interim guidance for laboratory testing
  2. WHO interim guidance for laboratory biosafety related to COVID-19 virus
  3. Molecular assays to diagnose COVID-19 virus
  4. WHO refence laboratories providing confirmatory testing for COVID-19
  5. Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory testing for COVID-19 virus
  6. Laboratory Assessment Tool for laboratories implementing COVID-19 testing
  7. Scientific brief: Advice on the use of point-of-care immunodiagnostic tests for COVID-19

1. WHO interim guidance for laboratory testing

The purpose of this document is to provide interim guidance to laboratories and stakeholders involved in laboratory testing of COVID-19 virus.

- Read the document  (updated 2 March 2020)

 

Diagnostic testing for COVID-19 is critical to tracking the virus, understanding epidemiology, informing case management, and to suppressing transmission. This document describes the strategic use of diagnostic testing in different transmission scenarios of the COVID-19 outbreak, from no cases to community transmission, including how testing might be rationalized when lack of reagents or testing capacity necessitates prioritization of certain populations or individuals for testing.”

- Laboratory testing strategy recommendations for COVID-19  (updated 22 March 2020)

2. WHO interim guidance for laboratory biosafety related to COVID-19 virus

The purpose of this document is to provide interim guidance on laboratory biosafety related to the COVID-19 virus to laboratories and stakeholders involved in COVID-19 virus laboratory work. This also includes the packaging and shipment requirements for sending specimens to WHO reference laboratories providing confirmatory testing for COVID-19. The latest update (13 May 2020) includes additional biosafety recommendations for the usage of Point of care (POC) or near-POC assays that could be performed at patient care settings with certain precautions.

- Read the document (uploaded 13 May 2020)

Biosafety training videos are available to learn more for biological safety cabinet (BSC) and Good Microbiological Practices and Procedures (GMPP)

- Access WHO biosafety video series

 

3. Molecular assays to diagnose COVID-19

Many in-house and commercial assays that detect the COVID-19 virus have been developed or are currently under development. Many of these molecular assays are currently being validated in partner laboratories. An overview of assays that have applied to FIND for participation in their assay assessment work can be found here.

In-house developed molecular assays

At the beginning of the outbreak, WHO supported access to COVID-19 in-house PCR protocols assays by posting them online on the WHO website. Protocols that have been shared can be accessed here. Being listed in this document does not imply any endorsement or validation by WHO. These protocol postings online are not being updated and may not reflect subsequent refinements of the assays.

 

4. WHO reference laboratories providing confirmatory testing for COVID-19

Countries who have no testing capacity and national COVID-19 laboratories with limited experience on COVID-19 virus testing are encouraged to send the first five positives and the first ten negative COVID-19 samples to WHO reference laboratories providing confirmatory testing for COVID-19.

List of COVID-19 reference labs  (Updated 29 April 2020)

Booking form (Updated 15 April 2020) 

For MS Word document format of the booking form please contact roviraj@who.int and fusterc@who.int

Contact details of WHO reference laboratories providing confirmatory testing for COVID-19 can be obtained from the respective regional WHO offices. 

5. Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory testing for COVID-19 virus

WHO has established a shipment mechanism to expedite and cover the costs of the shipment of clinical samples from patients with suspected COVID-19 from the country of collection to one of the WHO reference laboratories providing confirmatory molecular testing for COVID-19. This document explains the process and documentation required for shipment of specimens. 

- Access the document (updated 31 March 2020)

6. Laboratory Assessment Tool for laboratories implementing COVID-19 testing

This Laboratory Assessment Tool (LAT) is specifically designed to assess capacities of existing laboratories which have implemented or aim to implement COVID-19 virus testing. It addresses both core capacities of a laboratory and specificities related to COVID-19 virus testing. It is a focused and shorter version from the existing complete laboratory assessment tool that can be found at https://www.who.int/ihr/publications/laboratory_tool/en/

The target audience is any stakeholder performing laboratory assessments such as national health authorities, multilateral agencies, Non-Governmental Organizations (NGOs) and laboratory managers. Assessors can use the tool, and customized if needed, to meet local requirements or assessment context. This tool is an Excel file, which enables automatic calculations of module indicators.

- Access the tool

- Access the user guide (English - 8 April 2020)

7. Scientific brief: Advice on the use of point-of-care immunodiagnostic tests for COVID-19

Advice based on available evidence to date

- Read the brief (8 April 2020)