Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans
On this page you will find information about:
- Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases
- WHO interim guidance for laboratory biosafety related to COVID-19 virus
- Molecular assays to diagnose COVID-19 virus
- WHO refence laboratories providing confirmatory testing 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)
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.
- Read the document (uploaded 12 February 2020)
3. Molecular assays to diagnose 2019-nCoV
Several assays that detect the 2019-nCoV have been and are currently under development, both in-houseand commercially. Some assays may detect only the novel virus and some may also detect other strains (e.g. SARS-CoV) that are genetically similar.
In-house developed molecular assays
Some groups shared their protocols which can be accessed below (Summary table and link to the protocols). In some cases, the groups will be willing to send reagents or reagent mixes prepared in their laboratories, with or without associated fees. It is strongly recommended to contact the developer if you need further assistance. The list is not exhaustive and is being updated regularly.
Summary table of available protocols
|China||China CDC||ORF1ab and N|
|Germany||Charité||RdRP, E, N|
|Hong Kong SAR||HKU||ORF1b-nsp14, N|
|Japan||National Institute of Infectious Diseases, Department of Virology III||Pancorona and multiple targets, Spike protein|
|Thailand||National Institute of Health||N|
|US||US CDC||Three targets in N gene|
|France||Institut Pasteur, Paris||Two targets in RdRP|
China CDC Primers and probes for detection 2019-nCoV (24 January 2020)
Diagnostic detection of Wuhan coronavirus 2019 by real-time RT-PCR – Charité, Berlin Germany (17 January 2020)
Detection of 2019 novel coronavirus (2019-nCoV) in suspected human cases by RT-PCR – Hong Kong University (23 January 2020)
PCR and sequencing protocol for 2019-nCoV - Department of Medical Sciences, Ministry of Public Health, Thailand (Updated 28 January 2020)
PCR and sequencing protocols for 2019-nCoV- National Institute of Infectious Diseases Japan (24 January 2020)
US CDC Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus (28 January 2020)
US CDC panel primer and probes– U.S. CDC, USA (28 January 2020)
Real-time RT-PCR assays for the detection of SARS-CoV-2 Institut Pasteur, Paris (2 March 2020)
Disclaimer: The order on the list is by country of the hosting institution and does not imply any preference of WHO. Neither the names of vendors or manufacturers included in the protocols are preferred/endorsed by WHO. The protocols have not yet been validated through a WHO process.
Assumptions: Most procedures assume a basic familiarity with PCR/RT-PCR assays.
Safety Information: Specimen processing should be performed in accordance with pertaining national biological safety regulations and following the recommended WHO guidelines on biosafety and biosecurity.
Protocol use limitations: Optional clinical specimens for testing has not yet been validated.
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.
Current list of WHO reference laboratories providing confirmatory testing for COVID-19 (Updated 2 March 2020)
Guidance for laboratories shipping specimens to WHO reference laboratories that provide confirmatory testing for COVID-19 virus (Updated 2 March 2020)
Booking form for national laboratories (Updated 11 March 2020)
For MS Word document format of the booking form please contact email@example.com and firstname.lastname@example.org
Contact details of WHO reference laboratories providing confirmatory testing for COVID-19 can be obtained from the respective regional WHO offices.