Guidance

Malaria reference laboratory: user handbook

Updated 20 August 2021

The laboratory and our services

The Malaria Reference Laboratory (MRL) is an ISO 15189 accredited medical laboratory (reference 9148) based at the London School of Hygiene and Tropical Medicine (LSHTM), which is a centre of excellence for scientific research and postgraduate education. The MRL provides an extensive service to users throughout the United Kingdom to include:

• malaria diagnosis
• epidemiological data for the Centre for Infectious Disease Surveillance and Control (CIDSC)
• prophylaxis advice for travellers
• training and technical advice on methodology and laboratory procedures

The services above are offered to:

• all hospitals
• UK Health Security Agency (UKHSA) and NHS laboratories
• General Practitioners
• private medical laboratories throughout the UK and abroad

Advice on the investigation of malaria and other parasitological diseases is always available. Technical training sessions can also be arranged for small or large groups.

The laboratory processes around 2,000 specimens annually and participates in the UK National External Quality Assessment Service (NEQAS) quality assurance schemes for blood parasitology, malaria rapid tests and malaria molecular investigations.

Laboratory policy

Our policy is to offer a first-class diagnostic and reference facility for malaria and other blood parasites. We are also strongly committed to active research into malaria and its diagnosis and to the provision of training for pathology staffs, other healthcare professionals and those working in the control of infectious diseases.

Using this handbook

This handbook is designed to aid and advise the user on the appropriate use of the facilities to include diagnostic, teaching and advisory services. This is not an exhaustive document and users who can’t find what they are looking for should contact the laboratory for help and advice.

Further copies of this handbook can be downloaded from the MRL website where referral forms, other useful information, and related links can also be found.

Feedback

We encourage feedback from users of our services and welcome any suggestions that could improve customer satisfaction. Suggestions, queries or complaints should be made to Dawn Britten, Quality Manager on 020 7927 2427/2343 or Claire Rogers, Principal BMS on 020 7927 2318.

Laboratory

Laboratory opening times

The diagnostic laboratory is open between the hours of 9am to 5pm Monday to Friday, when staff are available for advice, information, specimen reception and processing.

Most routine specimens are sent to us by post or DX. Any urgent specimens are usually delivered by courier and accepted during opening hours.

Telephone urgent requests before sending so we know they are coming and what their priority status is. For prophylaxis advice see Diagnostic and Advisory Services.

Out of hours and public holidays

We are a reference facility so we do not provide an on-call service. The majority of specimens we receive will have had a preliminary diagnosis made by the sender or primary laboratory and so are usually non-urgent.

Any specimens delivered to the MRL out of normal hours and where no prior arrangement with us has been made will be dealt with the next working day. Laboratories are strongly urged to contact us by telephone if samples are likely to arrive after 5pm to prevent delays in diagnosis.

The laboratory is closed on public holidays and when there is an extended holiday period, including Christmas and New Year. Limited cover is arranged to deal with non-urgent postal specimens and all users are informed of these arrangements before the holidays.

When an urgent malaria diagnosis is required outside of normal hours, specimens should be referred to Clinical Parasitology, HSL Analytics LLP at the Hospital for Tropical Diseases (HTD).

Call 0845 155 5000 (UCLH Switchboard) and ask for the on-call Biomedical Scientist in Parasitology.

Please note that the HTD will charge for this service.

Location

The LSHTM is situated close to Tottenham Court Road, Goodge Street and Russell Square underground stations. It is a 10-minute walk from Euston station. Car parking is very restricted in the local area. The LSHTM has no parking facilities of its own.

Malaria Reference Laboratory
Faculty of Infectious and Tropical Diseases
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT

DX address:
HPA Malaria Reference Lab
DX 6641200
Tottenham Court RD92WC

Visitors

Visitors are seen by appointment only and should report to the reception desk in the LSHTM entrance foyer. Reception staff will then inform the laboratory of their arrival.

Please note that we are not able to see members of the general public and all patient referrals must be made by a registered health professional to the HTD, where the clinical service is delivered. There are no clinics at the LSHTM.

Staff and telephone numbers

Director

Professor P L Chiodini, Consultant Parasitologist: 020 7927 2427

Clinical Scientist

Dr Colin Sutherland, Professor of Parasitology: 020 7927 2338

Head of Teaching and Diagnostics Unit/Training Officer

Claire Rogers, Principal Biomedical Scientist (BMS): 020 7927 2318

Lead BMS, Molecular Diagnostics

Dr Debbie Nolder: 020 7927 2303

Lead BMS, Main Laboratory

Juliana Tucker: 020 7927 2427/2318

Lead BMS, Quality Manager

Dawn Britten: 020 7927 2427/2343

Senior BMS

Sarah Cheeseman, Emma Victory: 020 7927 2427/2343
and Helen Liddy, 020 7927 2303

Higher Scientific Officer

Lindsay Stewart: 020 7927 2343

Trainee BMS

Amy Gallimore: 020 7927 2427/2344

Medical Laboratory Assistants (MLA)

Karen Osborne, Helena Stone and Saba Entezam: 020 7927 2427

Surveillance Officers

Marie Blaze and Valerie Smith (contact by phe.malproph@nhs.net)

Laboratory telephone number for results and enquiries: 020 7927 2427

Laboratory fax number: 020 7637 0248

Diagnostic and Advisory Services

Information and enquiries

Diagnosis

For consultation on the investigation and diagnosis of malaria, interpretation of results and general information, contact the laboratory on 020 7927 2427.

Treatment

For treatment advice, contact the HTD on 0845 155 5000 (UCLH switchboard) and ask for the duty doctor in Infectious and Tropical Diseases.

Prophylaxis

The UK malaria prevention guidelines were formulated by the Advisory Committee on Malaria Prevention in UK Travellers (ACMP).

Note that these guidelines are intended for UK-based visitors to malaria endemic areas and are not appropriate for use by those residing in endemic areas.

Doctors, practice nurses, and other health professionals may email malaria prophylaxis queries to the MRL, using the risk assessment template available on the MRL website. Complete electronically, if possible, and email to phe.malproph@nhs.net You should receive a reply within 3 working days.

If your request is urgent, the National Travel Health Network and Centre (NaTHNaC) provides a telephone advice service for health professionals on 0845 602 6712.

Please note that the MRL cannot provide advice directly to members of the public who should consult their GP or a specialist travel clinic for advice. They may also visit the MRL web site but this is not a substitute for individual advice from a registered healthcare practitioner.

Specimens and containers

In order for us to provide a full service, where possible, provide for each patient:

• a minimum of 3.0 ml of the EDTA blood, on which you made your diagnosis
• 2 unstained methanol-fixed thin films, ideally made within 2 hours of blood being taken
• 2 unstained, unfixed thick films, ideally made within 2 hours of blood being taken

Package all specimens according to UN 3373 guidelines and telephone us if in any doubt as to which container to use or to discuss specific requirements.

Referral forms

A malaria report/referral form must accompany all specimens referred to the laboratory.

The MRL supplies report/referral forms specifically designed to provide us with all relevant information. Where possible these forms should accompany all malaria blood film diagnosis requests and should be completed as fully as possible. Copies may be downloaded from the MRL website. Hard copies can be supplied if preferred.

Minimum data set

We have minimum data requirements to ensure patient safety. Where specimens and referral forms are received that do not meet this criteria, we will contact the sender for more information but reserve the right to reject the sample.

Sample

It is essential to include:

• the patient’s full name or another coded patient identifier
• the patient’s date of birth or hospital/unit number or NHS number

It is desirable to include:

• the sending laboratory’s reference number
• the date the specimen was taken
• the nature of specimen including qualifying details, if applicable

Referral form

It is essential to include:

• the patient’s full name or another coded patient identifier
• the patient’s date of birth or hospital/unit number or NHS number
• investigation required
• the name and address of the requesting practitioner and name and, if different, address the reports should be sent to

It is desirable to include:

• the sending laboratory’s reference number
• the date the specimen was taken
• the nature of specimen including qualifying details, if applicable
• the telephone or pager number of the requesting practitioner
• the patient’s gender
• the sending laboratory’s diagnosis
• relevant clinical information

Please note the following extract from IBMS Professional Guidance:

Use of the NHS or CHI Number on paper and electronic patient records is now a mandatory requirement included within the NHS Operating Framework 2008 to 2009. Patient data should be used to identify the sample up to the point where an NHS or CHI Number is allocated whereupon this becomes the primary identifier.

Clinical information

The following clinical details should be included if available:

• antimicrobial therapy
• travel history
• risk status if applicable
• date of onset and duration of illness
• epidemiological information

Packaging

Packaging must comply fully with UK transport regulations for clinical specimens (UN 3373 regulations).

Specimens should be in an appropriate container, securely fastened and the accompanying request form should be placed in a separate area of the packaging so as not to be in direct contact with the specimens.

The outside of the package must be appropriately marked and clearly state ‘Biological substance - category B’.

If specimens are unlabelled or inadequately labelled and the patient’s identification is unclear, or if they have leaked or are contaminated, they may be unsuitable for testing. The requesting laboratory or doctor will be informed immediately by telephone to discuss the matter if this is the case and to arrange for repeat specimens if necessary.

As a reference laboratory, we do appreciate that some specimens cannot be repeated and every effort is made to avoid the need for repeat requests.

High risk specimens and safety

Specimens are regarded as high risk if taken from patients known, suspected or at risk of having serious infectious disease. Of note are blood-borne agents such as hepatitis, HIV or various viral haemorrhagic fevers or other infectious diseases such as tuberculosis or typhoid.

Hazard group 3 risks

In addition to the standard packaging instructions given, all high risk specimens must be labelled as ‘high risk’ both on the container and the request form, with a standard yellow ’danger of infection’ sticker, and placed in a biohazard bag. The precise nature of the infection risk should be clearly given in the clinical details.

Hazard group 4 risks

This is essentially referring to viral haemorrhagic fevers but also similar human infectious diseases of high consequence.

Specimens from a patient with a confirmed hazard group 4 pathogen cannot be dealt with in this laboratory. The referring clinicians must not send any specimens and must discuss the case with the Imported Fever Service on 0844 778 8990.

If the patient has a possible risk of a hazard group 4 pathogen the referring clinicians must first discuss the case with the Imported Fever Service on 0844 778 8990. The risk assessment and any VHF screening required as a result of this should have taken place before specimens are sent to us and we may receive specimens once the risk has been downgraded.

Specimen transport and reception

Most specimens are received via post, DX or courier. During normal working hours all specimens are received at LSHTM reception then forwarded to the reference laboratory. Outside normal working hours non-urgent specimens may be left at reception and will be dealt with on the next working day. Urgent samples should not be left but sent to HTD as detailed below.

Urgent investigations

Urgent specimens are usually delivered by courier and accepted during normal working hours. Telephone urgent requests before you send the samples so that we know they are coming, also ensure that you have provided full and correct contact details so that we can telephone the results back to you. Package as described above and mark clearly on the outside that it is urgent.

When an urgent malaria diagnosis is required outside of normal hours, specimens should be referred to Clinical Parasitology, HSL Analytics LLP at the Hospital for Tropical Diseases (HTD). Call 0845 155 5000 (UCLH Switchboard) and ask for the on-call Biomedical Scientist in Parasitology. Please note that the HTD will charge for this service.

If a specimen is on the way to the LSHTM and you need it to be re-directed to the HTD, you must arrange this directly with the courier, as LSHTM staff cannot authorise a courier to re-route.

Any specimens delivered to the MRL out of normal working hours, if special arrangements have not been made with us, will remain securely at LSHTM Reception until being transferred to the laboratory on the following working day.

Specimens and investigations

Specimen collection

Blood is ideally collected during fever, however, parasites are found at all stages of the infection and therefore blood films without delay are mandatory in all cases of suspected malaria. If the first films are negative, blood should be taken and films made and checked on at least 2 occasions over the first 24 hours and further films examined every 12 hours after that if strongly clinically indicated.

Blood taken into anticoagulant (EDTA should be used) should have films made as soon as possible to minimise morphological changes in the parasites, and certainly within 2 hours. However, parasites can be detected even after extended exposure to anticoagulant (exceptionally up to 24 hours) and no sample will be rejected unexamined.

Most specimens we receive have already had preliminary investigations carried out by a primary laboratory and are sent to us in due course.

In general, specimens should be collected or transferred into an appropriate container and/or blood smears made, with an accompanying referral form giving all relevant information, including laboratory findings and sent to us as soon as possible.

Please inform us of any known infection risks.

Ideally, the following specimen set should be sent for routine malaria investigation:

• a minimum of 3.0 ml (where possible) of the EDTA blood on which you made your diagnosis
• 2 unstained methanol-fixed thin films, ideally made within 2 hours of blood being taken
• 2 unstained, unfixed thick films, ideally made within 2 hours of blood being taken
• if a delay in sending specimen, for example due to the weekend, refrigerate blood prior to dispatch

Contact the laboratory to discuss individual cases, specific requirements or investigations that are not listed.

Specimen retention

If additional tests are requested after the initial referral, bear in mind that:

• blood films are retained for a minimum of 5 years
• blood is retained for 2 to 4 weeks at 2 to 8°C after receipt
• when blood is sent for a malaria polymerase chain reaction test (PCR), after DNA extraction, 1 mL aliquots of blood are held at -20°C indefinitely, where sample volume permits.
• DNA extracts are held at -20°C indefinitely

Laboratory investigation of malaria

Of human importance are Plasmodium falciparum, P. vivax, P. malariae, P. ovale spp. and P. knowlesi.

Diagnosis is made using the following methodologies, selected according to individual circumstances:

• microscopical examination of thin and thick blood films for the detection and species identification of malaria parasites (using Giemsa and Field’s stain)
• real-time PCR (screening) and nested PCR (gold standard) for malaria confirmation and species determination. PCR is not performed routinely on all specimens received for malaria diagnosis but at the discretion of MRL staff and according to laboratory algorithms
• immunochromatographic techniques for the detection of malaria antigen in blood
• for P.falciparum and P.knowlesi, parasitaemia estimation to indicate severity of infection and effectiveness of treatment, note that this is only performed upon request

Serology is no longer performed by this laboratory, but may be obtained from the Clinical Parasitology, HSL Analytics LLP at the Hospital for Tropical Diseases (HTD).

Other investigations are offered where appropriate. Each case should be discussed with the Clinical Scientist or Laboratory Clinical Director.

Investigations include:

• molecular markers for drug sensitivity in treatment or prophylaxis failure such as anti-folate resistance, atovaquone proguanil resistance or ACT/artemisinin failure to clear
• discrimination of parasite species P. ovale curtisi and P. ovale wallikeri which cause ovale malaria
• investigation of suspected HRP2/HRP3 antigen gene deletions in P. falciparum cases with evidence of RDT failure

Outbreak investigations

Cases of any of the Plasmodium species of malaria that are clustered in time or location can be investigated for genetic relatedness of the parasites responsible.

Note: Serology is occasionally useful in detecting evidence of past infection, but its main indication in the UK is for blood donor screening. It has no place in the diagnosis of acute malaria, for which blood films are mandatory.

Blood films are essential in cases of acute fever or other symptoms where malaria is suspected.

Malaria antibodies

Specimens are now processed by Clinical Parasitology, HSL Analytics LLP at the HTD and those received by the MRL will be forwarded to the HTD. Referring laboratories should send specimens directly to the HTD:

Clinical Parasitology, HSL Analytics LLP
Hospital for Tropical Diseases (HTD)
Mortimer Market
Capper Street
London
WC1E 6JB

Telephone 020 7307 9400 and ask for Parasitology Serology

Other blood parasites

The MRL deals with all malaria related requests. Microscopy for other blood parasite infections such as American and African Trypanosomiasis, Babesiosis, Filariasis, and Leishmaniasis is dealt with by the Diagnostic Parasitology Laboratory (DPL). The DPL is in the same department as the MRL and shares the same address and telephone number.

For information regarding these organisms, the tests carried out and the specimens required for diagnosis – refer to the DPL user manual which can be accessed and downloaded on the DPL website or call 020 7927 2427 to contact the laboratory staff.

Laboratory schedule and turnaround times

Generally, specimen processing starts on the day of receipt. Diagnosis by blood film and/or immunochromatographic techniques should be complete in 1 to 2 working days. Telephoned results can be available within 2 hours of receipt of specimen on request.

Diagnosis and/or confirmation by PCR is available in 1 to 4 working days depending upon complexity and urgency. All PCR results are given over the telephone as soon as the investigation is complete (supply a direct telephone number for results).

When complete, final reports are typed and posted the same or next working day. Interim reports are available upon request. Results of any urgent investigations will be telephoned to the requesting laboratory immediately.

Charges

At present all testing carried out by the MRL for NHS laboratories and UKHSA laboratories within England and Wales is free of charge. Laboratories outside England and Wales, such as those in the Republic of Ireland or private laboratories and other institutions will be subject to charges and these can be made available on request.

Should there be any change to this, all laboratories will be given a minimum of 3 months’ advance notice.

Results and reports

Written reports

Reports are printed and dispatched each working day. In most cases the written report is final, however, if further results are to follow, or if a repeat specimen is required, this will be clearly stated. Interim reports, where necessary, will normally be given by telephone and confirmed in a full and final written report. Interpretation of results and comments on individual cases will be given where required.

Telephone reports

The results of urgent investigations, those which may aid immediate patient management or any results specifically requested by the sending laboratory will be telephoned through as soon as they are available.

The name and status of the person receiving the report will be required for our records. A Clinical Scientist or the Laboratory Clinical Director will telephone to discuss results where clinical interpretation or advice is required.

The results of some investigations will be telephoned immediately to help patient management.

These include:

• primary diagnosis of malaria
• diagnosis of P. falciparum or P. knowlesi, where undiagnosed by the requesting laboratory
• any other pathogen where prompt initiation of treatment is considered necessary
• all urgent PCR results

All telephoned reports, whether initiated by the reference laboratory or the requesting laboratory, will be confirmed with a written report.

Contact the laboratory on 020 7927 2427 for your results or to arrange for copies of paper reports if not received.

Faxing results

Should the submitting laboratory require, the reference laboratory can fax interim and final results to a secure fax line (also known as a safe-haven).

Archiving of reports and security of information

All reference laboratory copies of written reports (to which the original request form is attached) are held in secure, locked storage for a minimum period of 5 years.

All staff have a duty of patient confidentiality, and as part of the induction process are aware that all patient-related information is confidential and all data is held in accordance with the Data Protection Act 2018 and GDPR.

Staff should adhere to the School’s Data Protection policy and related guidance. It is a mandatory requirement that all staff undertake the LSHTM online training on security of information and GDPR.

Obtaining information and results

Staff are always available during laboratory opening hours to discuss results and to give advice and information.

Contact the MRL on 020 7927 2427 from where queries can be answered or referred to appropriate personnel.

Updates to the handbook

Please note that this guidance is valid on the day that you print or download it. Always check for the latest version.