MERS-CoV: diagnostic testing
Information on taking,ÌýsubmittingÌýand processing clinical samples fromÌýpatientsÌýsuspected of having Middle East respiratory syndrome coronavirus (MERS-CoV).Ìý
Applies to England
Aim of guidance
This guidance supersedes guidance previously found in ‘Middle East Respiratory Syndrome Coronavirus (MERS-CoV)’.
It is aimed at clinicians and healthcare workers, health protection teams (HPTs) and clinical diagnostic laboratories inÌýbothÌýthe public and private sectors.
MERS-CoV reporting and diagnostics
Middle East respiratory syndrome coronavirus (MERS-CoV) is a zoonotic respiratory virus. It can be transmitted to humans through direct or indirect contact with infected dromedary camels or contaminated camel products. Human-to-human transmission does occur, throughÌýclose unprotected contactÌýwith MERS-CoVÌýpositive casesÌýin health care settings andÌýamong household members.
°Õ³ó±ðÌýÌý³¾²¹¾±²Ô³Ù²¹¾±²Ô²õÌý³Ü±è-³Ù´Ç-»å²¹³Ù±ð MERS-CoV epidemiological case data.
The UK government isÌýobligatedÌýto report any MERS-CoV positive cases to the World Health Organization (WHO) under the International Health Regulations (IHR) 2025 via the National IHR Focal Point. This guidance sets out the explicit testing and reporting criteria required by the NHS and the UK Health Security Agency (UKHSA) to meet these obligations.ÌýAs a notifiable disease,ÌýRegistered Medical PractitionersÌýare required toÌýnotifyÌýall suspected cases ofÌýMERSÌýurgently (withinÌý24 hours) to a health protection team, under Health Protection (Notification) Regulations 2010 (HPNR).
Primary diagnostic testing for MERS-CoVÌýis available at UKHSAÌýand CollaboratingÌýNHS RegionalÌýPublic HealthÌýLaboratories (PHLs) orÌýmay be offered byÌýnon-±«°±á³§´¡-»å±ð²õ¾±²µ²Ô²¹³Ù±ð»åÌýMERS-CoVÌý(NHS/non-NHS)Ìýtesting laboratories with adequately verified MERS-CoV assays holding appropriate accreditation.ÌýConfirmatory testing and characterisationÌýfor international reportingÌýisÌýperformed in the NationalÌýReference Laboratory in the Respiratory Virus UnitÌý(RVU), Colindale.
MERS-CoVÌýviruses are genetically diverseÌýand continuously evolving. Genomic surveillance at the animal interface isÌýlimited,Ìýand human cases are rare, with limited virus genome sharing. Consequently, thisÌýguidance takes into consideration associated uncertainties for diagnostics, including limited availability of contemporaneous virus positive materialsÌýfor up-to-date diagnostic assurance.
UKHSA guidanceÌýis available onÌýwhen to suspect a case of MERS-CoV,Ìýand the classification of contacts of MERS-CoV cases and follow-up advice.
Who to inform testing is taking place
The decision to test for MERS-CoV should be based upon the case definition and made after consultation with local NHS infection specialists and the local health protection team.
If testing isÌýrequired, the local HPT and NHS infection specialistsÌýwill provide advice onÌýinitialÌýmanagement of the case.
HPTs should inform the UKHSA Acute Respiratory Infections team when a MERS-CoV infection is suspected (via acute.respiratory@ukhsa.gov.uk),Ìýor phone the EEIÌýduty consultantÌýon-call, if out of hours.
Testing strategy for suspected MERS-CoV
Diagnostic testing for MERS-CoV should be undertaken for individuals according to the criteria described in MERS-CoV: diagnosis and management of cases and contacts - °Ç¸ç³Ô¹Ï.ÌýThe summary process is available asÌýan algorithm.
±«°±á³§´¡-»å±ð²õ¾±²µ²Ô²¹³Ù±ð»åÌýPHLsÌý´Ç´Ú´Ú±ð°ù MERS-CoV diagnostic testing for England. If the local NHS laboratory service offers an accredited MERS-CoV diagnostic test, samplesÌýmay be processed there.
±«°±á³§´¡-»å±ð²õ¾±²µ²Ô²¹³Ù±ð»åÌýPHLsÌýwill only accept samples for testing where the patient meets the case definition or after discussion with the local clinician explaining the need for testing. If initial tests are negative for MERS-CoV and the patient develops new relevant symptoms within the 14 days following exposure,ÌýswabbingÌýand testing should be repeated.
Sampling for diagnostic testing of MERS-CoV
Do not delay sampling and testing. Samples should be obtained and sent to aÌýMERSÌýtesting laboratory as soon as possible after identifying the possibility of MERS-CoV infection and results should be available within 24 hours of sample receipt. In exceptional situations where out of hours testing may be necessary, discuss options with the local NHS testing laboratory or UKHSA PHL duty consultant virologist.
When taking samples ensure that you are wearing theÌýrequired PPE.ÌýFurther guidance can be found in the NHS  and the . All samples must be labelled with the patient’s name, date of birth, NHS number, the date and anatomicalÌýsite of the sample. Unlabelled samplesÌýcannot be processed.
After consultation with theÌýHPTÌýand/or consultant infection specialist, the clinical team should take the following samples specifically for MERS-CoV testing:
- 2 upper respiratory tract samplesÌý(box 1)Ìý(nasopharyngeal viral swabs are preferable, but nose and throat swabsÌýare acceptableÌýwhere supported by local validation,Ìýor nasopharyngealÌýaspirate)
- the primary testing laboratory should use one sample for testing and store the second. The stored sample should be reserved forÌýforwardingÌýto RVU if a presumptive positive is detected and confirmation is needed. Ideally, the stored sample should be collected into virus transport medium (VTM), avoiding mediumÌýcontainingÌýan inactivating agent
- if obtainable and the patient’s symptoms or clinical assessment considers it appropriate, take a lower respiratory tract sample, 2 ifÌýfeasible (box 1) (sputum, or an endotracheal tube aspirate if intubated), in addition to the upper respiratory tract samples.ÌýAvoidÌýmediumÌýcontainingÌýan inactivating agent
If the local NHS laboratory service offers an accredited MERS-CoV diagnostic test, samples may be processed there. IfÌýprimary testingÌýis unavailable locally, sendÌýall samplesÌýtoÌýaÌýdesignatedÌýMERS ³Ù±ð²õ³Ù¾±²Ô²µÌý±«°±á³§´¡ÌýPHL for testing. Do not send samples directly to RVUÌýColindaleÌýfor primary testing.
AdditionalÌýsamples should be collected ifÌýotherÌýdiagnosticÌýtesting isÌýrequired by the localÌýlaboratory.
Box 1
AÌýsingleÌýnegativeÌýtestÌýresultÌýparticularly if fromÌýan upper respiratory tract sample,Ìýmay not exclude MERS-CoV in a patient withÌýclinically relevant travel history and disease. Where clinical suspicionÌýremains, repeatÌýsamplingÌýincluding fromÌýthe lower respiratory tractÌýif possibleÌýis recommended.ÌýLower respiratory tract samples obtained as soon as possible after symptom onset (less than 7 days) have the best diagnostic sensitivity. Studies have also shown shown thatÌýswabs taken from the nasopharynxÌýnot just the nostrilÌýhave a better diagnostic sensitivity for MERS CoV.ÌýNot all NHS laboratories will have the capability to test lower respiratory tract samples for MERS-CoV. Clinicians should discuss options with the local NHS testing laboratory or UKHSA PHL duty consultant virologist.
As the clinical features of MERS-CoV areÌýsimilar toÌýthose of other respiratory infections, consider testing for a wide range of respiratory pathogens,Ìýas thisÌýhelps inÌýdeterminingÌýa final cause for the illness, depending on the local epidemiology of circulating respiratory viruses and travel history.
What tests will be performedÌý
°Õ³ó±ðÌý±«°±á³§´¡-»å±ð²õ¾±²µ²Ô²¹³Ù±ð»åÌýMERSÌý³Ù±ð²õ³Ù¾±²Ô²µÌýPHLÌýwill useÌýverifiedÌýnucleic acid amplification tests for MERS-CoVÌýandÌýholdÌýappropriate accreditation.
Laboratories thatÌýtest for MERS-CoV can also perform seasonal respiratory virus screens if desired, but panels offered may vary. If a referring laboratory chooses to perform its own respiratory virus panel (in addition to requesting MERS-CoV testing), a local risk assessment should be performedÌýfor handling a suspected CL3 organism, and appropriate healthÌýand safety measures followed.
IfÌýalternate diagnoses are under consideration andÌýanyÌýadditionalÌýtestsÌýare required, please discuss with theÌýPHL at the time of referral.ÌýAlways inform each laboratory of the risk of infection with HG3/4 pathogens, prior to sendingÌýsamples, andÌýensure request forms clearlyÌýstateÌýthe HG3/4 risk
Non inactivated samples must be handled at CL3. Aliquots of the original sample should be separated and inactivated by lysis or other validated method. Following inactivation, sample aliquots may be handled at CL2 for molecular testing.ÌýIt is important to reserve someÌý(non-inactivated)Ìýmaterial suitable for virus culture should it beÌýrequired.
Transport of samples toÌýUKHSAÌýandÌýCollaborating NHSÌýRegional Public HealthÌýLaboratoriesÌýfor MERS-CoV diagnostic testing
Details of the address of each of theÌýUKHSA and Collaborating NHS Regional Public Health Laboratories that offer testing for MERS-CoVÌýare listedÌýinÌýTable 1Ìýand on the public health laboratoriesÌýwebsite.
Send all samples for MERS-CoVÌýprimaryÌýtesting to theÌýPHL.ÌýDo not send any samples directly to RVUÌýColindale. °Õ³ó±ðÌýPHLÌýwillÌýsendÌýsamples to the RVU ¾±´ÚÌý°ù±ð±ç³Ü¾±°ù±ð»å.
MERS-CoV is an Advisory Committee on Dangerous Pathogens (ACDP) Hazard Group 3 pathogen.ÌýDiagnostic samples should be sent byÌýCategory B transportÌý(UN3373, packing instruction P650), clearlyÌýindicatingÌýthat the samplesÌýcontainÌýa suspected HG3 pathogen on any referral form to ensure safe handling on receipt.
Provide theÌýcontactÌýdetails for your clinical laboratoryÌýfor the purposes ofÌýtelephoneÌýand hard copy reporting. This must include an out-of-hours telephone number.
Send samples by DX transfer or courier services according to urgency and timing.
The referring laboratoryÌýis responsible forÌýbooking and paying for the transport.
MERS-CoV test result communication
Results from theÌýUKHSAÌýandÌýCollaborating NHSÌýPHLsÌýshould be provided within 24 hours of receipt of the sample at the testing laboratory.
PHL staffÌýare responsible forÌýinforming the referring clinical centre,ÌýHPTÌýand UKHSA acute respiratory infections team of the results including via urgent phone communication to the referring clinical centre.
If testing has taken place outside of a ±«°±á³§´¡-»å±ð²õ¾±²µ²Ô²¹³Ù±ð»åÌýservice, the testing service must inform theÌýreferring clinical centre,Ìýand theÌýHPTÌýof the results including via urgent phone communication to the referring clinical centre.
The relevant clinical teamÌýthatÌýrequested the tests will need to be available to receive the results,Ìýwhich may be out of routine hours.
°Õ³ó±ðÌýlaboratoryÌýtesting process may generate negative, positive, or inconclusive results for the presence of MERS-CoV, as well as for the presence of other respiratory virus pathogens.Ìý
MERS-CoV testing results - definitions and actions forÌýprimary testing laboratories
MERS-CoV positive
If the NHS orÌýPHLÌýMERS testing laboratoryÌýobtains a presumptive positive result for MERS-CoV regardless of any other respiratory pathogen detection rapid communicationÌýis essential, so that public health control measures can be implemented.ÌýRefer to theÌýMERS-CoV: diagnosis and management of cases and contacts.
The primary testing laboratory shouldÌýcontact RVUÌýto arrange sending of samples for confirmatory testingÌýin the event ofÌýa MERS-CoV presumptive positive result. See section onÌýreferral of presumptive positives to RVUÌýfor guidance on sample referral.
MERS-CoV negative
If the test results show that the sample was MERS-CoV negative, then the patient should be managed according to any other relevant test results.
If appropriate samples were obtained and an alternative diagnosis is likely, then MERS-CoV may be considered excluded. In cases where a strong clinical suspicionÌýof MERS-CoV remains after a single negative test result, particularly if this is from an upper respiratory tract specimen, repeat sampling and testing, especially with lower respiratory specimens, is strongly recommended. For advice and to discuss options for further testing, the UKHSAÌýPHL or NHS duty microbiologist or virologist should contact the RVU.
MERS-CoV testing inconclusive
Where inconclusive results are obtained, the patient should continue to be managed as a suspected MERS-CoV case, until a definitive result is obtained unless a clear alternative diagnosis has been made and dual pathology excluded.
Referral of presumptive positive MERS-CoV human samples to the Respiratory Virus Unit, ColindaleÌý
All presumptive positive MERS-CoV positive samples must be notified to RVU by telephone and arrangements made toÌýsendÌýurgently for confirmatory testing and virus characterization including whole genome sequencing.
For cases where MERS-CoV testing was inconclusive, or where negative results have been obtained, but clinical suspicionÌýremains,ÌýPHL or NHS laboratoriesÌýshould contact the RVU to discussÌýappropriate testingÌýand sample referral.
To contact RVUÌýColindaleÌýwithin working hours (Monday to Friday, 09:00 to 17:00) telephone:
- 020 8327 7125
- 020 8327 7002
- 020 8327 6017
If managingÌýout of hours, contact the Epidemic and Emerging Infections (EEI)Ìýduty consultantÌýfor advice.
After discussion with RVU, samples should be sent by categoryÌýBÌýtransport, packaged accordingly, with clear labelling toÌýindicateÌýan urgent sample with suspected Hazard Group 3 pathogen. Routine daily DX transfer can be used (package separately from other samples)Ìýor specific courier services depending on urgency and timing.
The completedÌýE16 MERS-CoV referral formÌýmust be included in the package.
All available original clinical samples collected for testing, including residual material from the tested sample and theÌýsecond reserve sample,Ìýmust be sentÌýto RVUÌý(minimum 400µl, in VTM, not lysed or inactivated). Non-inactivatedÌýmaterialÌýis important due to suitability for virus culture.ÌýIn the event there is a lower volume, or no clinical material remains, contact RVU for further advice.
Reporting of confirmatory MERS-CoV resultsÌýby the Respiratory Virus Unit
RVU will report all results of confirmatory testing, positive and negative, by phone to the referring laboratory.
The Acute Respiratory Infections Team should be notified by phone (followed up by email) in hours. Out of hours, notify the EEIÌýduty consultantÌýby phone. The local HPT will be updated by the ARI team if results are obtained during working hours, or by the EEI consultant outside of working hours.
MERS-CoV diagnostic testing algorithm
The diagnostic testing algorithm summarises the clinical assessment and sample pathway and is to be used by healthcare professionals for testing suspected MERS cases.
Download the MERS-CoV diagnostic testing algorithm.
ContactsÌýfor arranging MERS-CoV testing
1. UKHSA and collaborating NHS regional public health laboratories
| Region/HPT | UKHSA MERS-CoV testing laboratory |
|---|---|
| Midlands | Midlands Regional Public Health Laboratory (UKHSA Birmingham) |
| South East | Midlands Regional Public Health Laboratory (UKHSA Birmingham) |
| South West | South WestÌýRegional Public Health Laboratory (UKHSA Bristol) |
| East of England | Midlands Regional Public Health Laboratory (UKHSA Birmingham) |
| London | Midlands Regional Public Health Laboratory (UKHSA Birmingham) |
| North East | North EastÌýPublic Health Laboratory (Newcastle) |
| North West | North WestÌýRegional Public Health Laboratory (UKHSA Manchester) |
| Yorkshire and the Humber | North WestÌýRegional Public Health Laboratory (UKHSA Manchester) |
2. UKHSA national teamÌýcontact details
| UKHSA team | Phone | |
|---|---|---|
| Respiratory Virus Unit, Colindale | rvu.incidentresponse@ukhsa.gov.uk | 0208 327 7125 0208 327 7002 0208 327 6017 |
| Acute Respiratory Infections Unit | Acute.respiratory@ukhsa.gov.uk | 0208 200 4400Ìý(ask to speak with ARI duty senior) |
| Epidemic and emerging infections duty consultant | n/a | 020 7123 0333 |
3. Contact information for local health protection teams
Find your local health protection team
4. Public health laboratories
More about Public health laboratories