HIV Point Of Care Testing
Operations Manager, Virology
Infection and Immunology DU
„Same-day‟ to POCT
• Virology approached by GUM early 2004
• They wished to replace same-day with
POCT clinics in GUM.
• Also wished to set up POCT at a GP site
• Wished for advice and support from
• Chosen test already in use at C&W GUM
• Departure – first time non-laboratory staff
had done serology test.
• Nurses and health advisers were to carry out
• Virology staff offered to train clinic staff.
• Virology staff asked to advise on testing
• 1. Trust governance - ? Good for patient
• 2. Choice of test – only one CE-marked
• 3. Training
• 4. Quality – QC and QA
• 5. Multi-disciplinary
• 6. Audit
• Documentation: Operational policy, liaison between medical
and laboratory team, cost benefit analysis.
• Conform to Trust POCT policy. Draft policy found.
Pathology now has a POCT manager. Various programs within Trust.
• Advantages and disadvantages clear
– 1 hour result instead of 2/3 days
– More expensive test but greater patient satisfaction.
– Less sensitive than lab-based assays for early infection
– Stress on clinic staff; rapid result. Proper training and support.
2. Choice of test
• Abbott Determine already assessed at
Chelsea & Westminster.
• Only test CE-marked at the time
• Senior BMS and clinical scientist. Day and a half course.
• Tutorials – half day
– HIV, virus, disease and lab. diagnosis
– Principles of the Determine test
– Health and Safety; general and test
– Quality – QC and QA
• Practical instruction – full day
– How to use capillary
– How to interpret control
– SOPs, result sheets
– Testing panel of specimens
– Introduction to NEQAS
4. QC and QA
- procedural control in test
- Virology lab pre-tests new batches with controls supplied
by HPA Standards Laboratory.
- SOPs for QC preparation and performance
- Two staff read results.
- Algorithm for repeat testing and confirmation
- participation in external scheme. ?NEQAS
Both sites – GUM clinic and GP clinic
• Following 3 years of use in GUM clinic:-
• Adapted vertical audit, with clinic cooperation
• Concentrated on 3 areas:
1. Health and Safety
2. Performance of test
3. Clinic Procedures
Good result with performance and procedures. Only
minor re-inforcing of safety measures required.
5. Multidisciplinary approach
training GUM medic
and confirmation. and Trust Governance
Consultant and senior scientists
and Health Advisers-
named individual lead
• 39 staff trained
• GUM clinic POCT still going strong.
• GP clinic folded 2007 – needs lots of local
• More community POCT clinics planned.
• Audit performed late 2007
GUM Clinic Community clinic
Start date Oct 2004 Feb 2005
Individuals tested 1564 364
Positives 45(confirmed) 11 (confirmed)
1 false pos
HIV prevalence 2.9% 3.02%
NEQAS All correct All correct
Findings of GP pilot study.
• One aim had been to encourage African
residents to be tested.
• Study* found that the GP service was used
significantly more by the Black ethnic
community c.f. the GUM clinic:
(16.5% v 8.7 % for same period).
• Fewer MSM at GP c.f. GUM (34.5% v
• *Surah et al. Paper submitted to STI
HIV POCT QA update
• Worth doing if multiple sites take it up.
THT may provide access to sites.
• ? small number of samples, more often
• ?small volumes
• ?spiked whole blood – how to preserve,
inactivate, ship etc
POCT and CPA
• What is the laboratory‟s role in POCT?
• Our Trust taking an ever greater interest.
• Full control of training, routine testing, QC
and QA? Suitable accommodation?
Accountable to CPA?
• Advisory role? Not responsible for service?
CPA not involved?
The Carter Report
Review of NHS Pathology Services in England (2006)
“..fragmentation of parts of the service,
particularly point-of-care services which are
increasingly being undertaken by other
members of the health care team, often with no
reference to pathology services…”
The Carter Report
Review of NHS Pathology Services in England (2006)
(ix) the independent accreditation process is reviewed to
ensure flexibility of approach and is extended to cover
all providers of pathology services (including point-of
(x) all pathology providers, including point-of-care
testing providers, are accredited in accordance with a
national independent accreditation process….
..and which requires full participation in external quality
Modernisation Initiative – evaluation
of HIV rapid test kits
• Abbott Determine in
Two other tests:-
Comparison of patients‟ samples
ABBOTT INSTI RAPIDAN
Positive Negative fail Positive Negative fail
106 106 0 0 102 1 3
HIV1 (100%) (96.2%) (0.9%) (2.8%)
100 0 100 0 0 100 0
negative (100%) (100%)
Evaluation of 3 kits using QA/QC
Results for NEQAS panel samples
NEQAS Nos Abbott INSTI Rapidan
HIV-1 positive 15 15 (100%) 11* (73%) 15 (100%)
HIV-2 positive 1 1 0 0
HIV negative 8 8 (100%) 8 (100%) 8 (100%)
*2 negative and 2 indeterminate
Only the Abbott assay detected the HIV-2 positive sample
Results for 3 internal QC samples
QC sample Abbott INSTI Rapidan
Negative Neg Neg Neg
HIV-1 positive Pos Neg Pos (weak)
HIV-2 positive Pos Neg Neg
HIV-2 positive sample not detected by INSTI and Rapidan.
INSTI failed to detect the HIV-1 positive and only a weak positive result was given with this sample by the Rapidan kit
Results for HIV-2 positive clinical samples
Sample Nos Abbott INSTI Rapidan
HIV-1/HIV-2 1 1 1 1
HIV-2 4 4 4* 4**
*2 results were very weak, ** 3 results were very weak
Evaluation in community
- Several THT clinics each using the
Determine. 100 tests at each site.
- Both will run the INSTi and the RAPIDAN
in parallel with the Determine.
- A „real-life‟evaluation of those assays in
comparison with Determine: ease of use,
safe handling, interpretation.
• Tests are available on the internet for self-
testing – all test for antigen. E.g 15 mins
• Testing services available on internet – e.g.
THT – pack sent to patient who takes own
specimen and sends for testing. – 2 days
• Gold standard now NAAT.
• Some tests are for „own use‟, some for
„professional use‟ only.
Sensitivity vs. accessibility
• Debate about choosing less-sensitive over tech.-demanding
test to avert STIs.
• Vickerman et al. estimate required sensitivity at only 50%
if either 55% fail to return for treatment and there is no
transmission, or 80% return and 50% infect partner during
• One rapid Ag test claims sensitivity of 81% c.f. SDA and
83% c.f. PCR. (BMJ 2007).
• > 3-year experience of HIV POCT.
• Clinic / laboratory collaboration essential
• QA material for POCT needed.
• Lab evaluation of other kits gives concern
• Community-based evaluation will be
• Desire for other infectious disease POCT.
• Virology, GSTT • Genitourinary medicine,
• Dr. S. O‟Shea GSTT
• Dr. W. Tong • Dr. Emma Fox
• Ms. K. Ashworth • Dr. Cindy Sethi
• Ms. S. Sliney • Ms. Chikami Shimada
• Ms. J. Stone • Ms. Rebecca Bickersteth
• Mr. Dilip Lakhani
• Lambeth Walk GP
• Ms. Christina Fitzgerald • Modernisation Initiative
• Ms. Maria Walker • Keith Marshall
• Ms. Andrea Scott