Guidance

Testing for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in England

Updated 28 February 2024

Applies to England

Scope

This guidance describes the process for primary and confirmatory testing of human samples for MERS-CoV testing when MERS-CoV is being considered as a diagnosis.

The emergence of MERS-CoV in humans was first recognised in 2012, and transmission from camels to humans in some countries continues. Human-to-human transmission has been identified, particularly in healthcare settings, with nosocomial outbreaks having most often been associated with exposure to persons with unrecognised MERS-CoV infection.

The UK government is obligated to report any MERS-CoV positive cases to the World Health Organization (WHO) under the International Health Regulations (IHR) 2005 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.

Samples can be referred to UKHSA-designated MERS-CoV testing public health laboratories (PHLs) or non-UKHSA-designated MERS-CoV testing laboratories with adequately verified MERS-CoV assays holding appropriate accreditation.

The National MERS-CoV Reference Laboratory at the UKHSA Respiratory Virus Unit (RVU), Colindale performs confirmatory testing for all presumptive positive MERS-CoV samples, regardless of where primary testing is performed.

Advice for public health laboratories in the devolved administrations

A similar but region-specific and locally agreed testing process applies to laboratories in Wales, Scotland and Northern Ireland.

Public health laboratories in Wales, Scotland and Northern Ireland may follow this sample referral guidance. Clinical diagnostic laboratories in Wales, Scotland and Northern Ireland that perform MERS-CoV testing are advised to contact their respective public health agencies to discuss arrangements for confirming a presumptive positive MERS-CoV result.

MERS-CoV testing: flowchart

 

Footnotes

1. Laboratories that test 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 performed, and appropriate health and safety measures followed.

2. If appropriate samples were obtained and tested in a verified or validated assay according to accreditation principles, then MERS-CoV infection may be considered excluded. If clinical suspicion remains, the local clinician or microbiologist should discuss repeat sampling and testing with the MERS-CoV testing laboratory.

3. All presumptive positive MERS-CoV samples must be sent to RVU for confirmatory testing, regardless of where the primary testing was performed.

4. In the event of an indeterminate result, RVU will contact the relevant local microbiologist or virologist.

Deciding whether testing is indicated

For possible MERS-CoV infections, the local clinician should follow the respective UKHSA investigation and management algorithm.

If the patient fulfils the case definition, infection prevention and control (IPC) and personal protective equipment (PPE) guidance for MERS should be followed and the patient managed in a negative pressure room.

MERS diagnostic testing should be requested as soon as possible. Samples should be obtained and sent to a primary MERS testing laboratory within 12 hours of case suspicion.

The initial MERS testing result should be reported within 24 hours of sample receipt in the testing laboratory.

Notifications required for a possible case

In hours

(9am to 5pm on weekdays)

The referring clinician must notify the local UKHSA health protection team (HPT) about the possible case and intention to test.

The HPT will notify the TARZET Acute Respiratory Team (acute.respiratory@ukhsa.gov.uk) in UKHSA.

Out of hours

(5pm to 9am on weekdays, and all day weekends and bank holidays)

The referring clinician must notify the local UKHSA HPT out of hours about the possible case and intention to test.

The HPT will notify the CEI Out of hours Duty Consultant. On the next day, the HPT will email the Acute Respiratory Team (acute.respiratory@ukhsa.gov.uk).

Sample testing

Testing should not be delayed; samples should be obtained and sent to a MERS testing laboratory within 12 hours of suspicion.

The recommended minimum diagnostic sample set for MERS-CoV testing is:

• an upper respiratory tract sample (a combined nose and throat viral swab, or nasopharyngeal aspirate)
• a lower respiratory tract sample (such as sputum, endotracheal tube aspirate or BAL if intubated), if obtainable

Lower respiratory tract samples obtained as soon as possible after symptom onset (less than 7 days) have the best diagnostic sensitivity. A negative result for an upper respiratory tract sample may not exclude MERS in a patient with lower respiratory tract disease.

Appropriate PPE and IPC measures should be used when obtaining diagnostic samples.

All samples for MERS-CoV testing should be handled at Containment Level 3 in sample handling laboratories.

Samples may be sent to UKHSA-designated MERS testing laboratories for testing or tested at the hospital’s own laboratory (NHS or private) if it has a validated MERS assay. However, all presumptive positive samples tested at non-UKHSA laboratories should be forwarded to the relevant UKHSA testing laboratory for confirmation.

Testing by a UKHSA-designated MERS testing site

Send the samples to the appropriate PHL testing laboratory (see below) after notifying the PHL by telephone.

The referring hospital or laboratory is responsible for arranging the urgent transportation of samples.

Samples must be sent by Category B transport urgently.

The referring laboratory should provide contact details for telephone, email address and postal address, including an out-of-hours contact.

The MERS-CoV testing laboratory should remind the referring centre to follow IPC guidance and inform the local HPT.

London, South West, South East, East of England, West Midlands, East Midlands

Samples arising in these regions should be sent to Birmingham PHL:

Public health laboratory Birmingham

Heart of England NHS Foundation Trust
Bordesley Green East
Birmingham
B9 5SS

Email phebirmingham@heartofengland.nhs.uk

Telephone 0121 424 2500

Out of hours: ask for the on-call microbiologist or virologist on 0121 424 2000

North West, Yorkshire and the Humber, North East

Samples arising in these regions should be sent to Manchester PHL:

Public health laboratory Manchester

Manchester Medical Microbiology Partnership
Clinical Sciences Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WZ

Telephone 0161 276 8788 / 8854

DX address DX 6962410 Manchester 90M

Out of hours: ask for the on-call microbiologist or virologist on 0161 276 1234

Testing by a non-UKHSA-designated testing laboratory (including NHS and private)

Non-UKHSA-designated testing laboratories include NHS and private laboratories with locally verified/validated MERS testing capability.

Laboratories undertaking MERS-CoV testing should ensure that they have assurance about the performance of the assay they are using, following the principles of accreditation.

Current MERS guidance and Infection, prevention and control, including decontamination guidance should be followed.

All presumptive MERS positive samples from these laboratories should be urgently forwarded to the Colindale UKHSA laboratory for confirmation.

Pan coronavirus test results

Samples from suspected MERS cases should be investigated using MERS-CoV specific assays. Generic coronavirus assays (‘pan-coronavirus’ assays), SARS-CoV-2 or seasonal human coronavirus assays should not be used for this purpose.

Detection of other respiratory pathogens does not rule out the possibility of MERS-CoV infection, therefore all cases meeting the case definition should be tested for MERS-CoV.

Confirmatory testing of presumptive positives by UKHSA’s RVU

Samples for primary testing must not be sent to RVU.

Presumptive positive MERS-CoV samples should be forwarded urgently to RVU for confirmatory testing, including at weekends.

Samples should not be sent to RVU without prior notification, and they should not be sent as part of routine sample deliveries.

The sending laboratory is responsible for arranging transportation of samples.

RVU will advise on the planned testing schedule, to aid in decisions on the type of urgent transport to use (for example courier, pathology bike, Tracked DX).

RVU contact and shipping information

Dr Katja Hoschler, Deputy Unit Head or Prof Maria Zambon, Consultant Virologist
Respiratory Virus Unit
61 Colindale Avenue
London
NW9 5EQ
Telephone: 0208 327 7002 or 0208 327 6017
Email: rvu.incidentresponse@ukhsa.gov.uk

Residual material from the original clinical sample(s) should be sent.

A minimum volume of 200 µl, ideally 400 µl is required. If the remaining volume is insufficient, contact RVU for further advice.

Include a completed E16 referral form for confirmatory testing for MERS CoV giving:

• case details
• presumptive result(s), including Ct value(s) if known
• number and type(s) of samples being sent
• transport arrangements and expected time of arrival

All samples should be packaged and transported in accordance with Category B transport regulations. UN 3373 packaging must be used for sample transport.

Reporting of confirmatory MERS-CoV results

RVU will report all results of confirmatory testing, positive and negative by telephone to:

• the laboratory that produced the presumptive positive result
• the clinical laboratory that referred the sample initially (for example NHS laboratory)
• the relevant PHL microbiologist or virologist
• the local HPT
• Acute Respiratory Infections Team UKHSA, Colindale

Referral of further specimens from confirmed positive cases

Once a presumptive positive MERS-CoV result has been confirmed by testing at RVU, follow-up samples will need to be tested for MERS-CoV. These may include non-respiratory samples such as serum/plasma, faecal and urine specimens. The UKHSA incident management team, working in conjunction with the local clinical team and RVU, will advise on the types of samples required and where samples should be sent.