Considerations

Published: 30 June 2012

Use of rapid testing tends to increase the number of people seeking a test and the number of people receiving their test results.1 While the test kits themselves can be cheaper than laboratory-based methods, there are considerable costs to running outreach clinics outside a hospital setting.2

If there is a significant risk of recent infection, rapid tests should not be used exclusively, but could be used in addition to a more sensitive test. Moreover, if the patient also needs testing for other sexually transmitted infections, these results will not usually be available for several days, and the patient may need to come back to the clinic for treatment.

A reactive result, as with a reactive result to any other test, requires further testing to confirm the diagnosis. Before testing, patients will need to be informed of this. Staff using rapid tests will need training in how to explain reactive results , and how to support patients who receive them.

Similarly, some results will be indeterminate, equivocal or difficult to interpret. Some testing centres will immediately re-test using a second rapid test, from a different manufacturer, in order to clarify the situation. However if a second test is not available, or if the second test was also indeterminate, laboratory confirmatory testing will be required. The person having the test may be anxious and confused at this point.

A negative result is usually considered conclusive and does not require follow-up testing. However, because of the window period, it is advisable for someone with possible recent exposure to HIV to retest at three months.

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Because they are easy to use, rapid tests may be performed by staff with limited formal laboratory training. However reading the test result relies on subjective interpretation, and when the result is borderline, experienced staff may give more consistently accurate results. Moreover, in a low prevalence setting, staff may not see enough true positive samples to gain experience in interpreting test results.

Technical errors can occur if instructions are not followed carefully. Rapid testing should be subject to the same strict quality assurance principles as practised by accredited laboratories, but this is not always the case.3

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice and guidance4 on the management and use of point-of-care testing (POCT), covering:

  • the importance of identifying a clinical need before a decision is made to introduce POCT.
  • clinical governance issues relating to the setting up and management of POCT.
  • the need for local hospital pathology laboratory involvement in all aspects of a POCT service.
  • the need for training, updating and monitoring of all staff involved in the POCT service.
  • quality issues including:
    • accreditation by an external certification body
    • the need for an appropriate quality control procedure
    • membership of an External Quality Assessment Scheme (where available)
    • the importance of health and safety
    • the need for standard operating procedures (SOPs) and for regular reviews and updates when necessary.

Rapid tests are not suitable for screening large numbers of people as there is a limit to the number of tests that one user can read at any one time - automated laboratory ELISA testing is more appropriate.

When it is appropriate to use rapid tests

  • In high-prevalence settings, or when the patient is at high risk of infection.
  • In clinic settings where a rapid turnaround of testing results is desirable.
  • When the patient may not come back for test results.
  • In community or outreach settings, away from specialised laboratory facilities.
  • When a pregnant women is about to go into labour and has not previously been tested for HIV.
  • After a possible sexual exposure or after a needlestick injury, to check the person thought to have HIV, before beginning PEP.
  • For the person requesting PEP (to check that he or she isn’t already HIV-positive).
  • When someone refuses venepuncture.

References

  1. Spielberg F et al. Choosing HIV Counseling and Testing Strategies for Outreach Settings: A Randomized Trial. Journal of Acquired Immune Deficiency Syndromes 38: 348-355, 2005
  2. Weatherburn P et al. Evaluation of the Department of Health funded fasTest HIV testing in the community pilot. Sigma Research, 2006
  3. Moses S et al. UK CVN audit of HIV diagnostic service provision and practices 1st joint CVN, HPA, CHAIN and BHIVA meeting, London, 2010
  4. MHRA Management and use of IVD point of care test devices. MHRA, 2002
This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.