Novel Coronavirus (2019-nCoV) technical guidance: Laboratory testing for 2019-nCoV in humans
Overview
On this page you will find information about:
- The current version of the “WHO interim guidance for laboratory testing for 2019 novel coronavirus (2019-nCoV) in humans”.
- Molecular testing of 2019-nCoV.
- WHO appointed 2019-nCoV referral laboratories and procedures.
- Diagnostic knowledge gaps.
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 samples from patients who meet the case definition of the novel coronavirus identified in Wuhan, China.
2. Molecular assays to diagnose 2019-nCoV
Several assays that detect the 2019-nCoV have been and are currently under development, both in-house and 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
| Country | Institute | Gene targets |
| China | China CDC | ORF1ab and N |
| Germany | Charité | RdRP, E, N |
| Hong Kong | 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 N primers, 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 panel primer and probes– U.S. CDC, USAV – U.S. CDC, USA (28 January 2020)
US CDC panel primer and probes– U.S. CDC, USA (28 January 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.
3. WHO appointed 2019-nCoV referral laboratories
Countries who have no testing capacity can send their samples to the WHO appointed 2019-nCoV referral laboratories for testing. National 2019-nCoV laboratories with limited experience are encouraged to send the first five positives and the first ten negative 2019-nCoV samples to their referral laboratories for confirmation.
Current list of WHO-appointed 2019-nCoV referral laboratories (Updated 10 February 2020)
Shipping instructions for national laboratories with 2019-nCoV specimens that require testing (Updated 7 February 2020)
Booking form for national laboratories (Updated 7 February 2020)
For Word format or HAZGO booking form, please contact roviraj@who.int and fusterc@who.int