Advisory

2002-31
April 29, 2002

Health Canada advises Canadians about potential false results with certain rapid HIV test kits

OTTAWA - Health Canada is advising Canadians of reported problems identified with the following rapid HIV test kits: the Fast-Check HIV-1/2 (serum) test and the Fast-Check HIV-1/2 (whole blood) test. The Fast-Check HIV-1/2 (serum) test is used to test human serum or plasma for antibodies to Human Immunodeficiency Virus (HIV). The Fast-Check HIV-1/2 (whole blood) test is used to detect HIV antibodies in human blood.

The rapid test uses a finger prick drop of blood and the result is given to the patient after 15-20 minutes. It should be noted that these kits are not home test kits. They are intended for use under the supervision of a health care professional.

The problems, as identified by the British Columbia Centre for Disease Control (BCCDC), are related to the sensitivity of the test - there is a potential for some individuals to have received a false negative result. This means that a test which ought to have given a positive result may have given a negative one in error.

The manufacturer, BioChem ImmunoSystems, has agreed to stop sale of all lots of the Fast-Check HIV-1/2 (serum) test and Fast-Check HIV-1/2 (whole blood).

Health Canada is issuing a letter to health care professionals who perform HIV testing informing them of these concerns. Individuals seeking additional information should contact their health care professional, clinic, physician or Provincial or Territorial Public Health Laboratory.

Advice to Canadians

Health Canada is advising anyone who received a negative result on an HIV rapid blood test since March 2000 as their sole HIV test, to contact the clinic or health care professional for further testing and counselling because that negative result is not reliable. There is a small chance that a person might be HIV positive in spite of receiving a negative HIV rapid test result.

Why is Health Canada sending this advisory?

On April 10, Health Canada received from the BCCDC the results of an evaluation of the Fast-Check HIV-1/2 (serum) test kit. Results of the study showed that the test kit failed to detect four out of approximately 400 HIV known positive samples.

On April 25, 2002, the BCCDC notified Health Canada of preliminary study results indicating that the Fast-Check HIV-1/2 (whole blood) test may also have the potential to produce false negative results. Two out of 14 known positive samples tested were incorrectly reported as negative on the Fast-Check HIV-1/2 (whole blood). This test uses blood usually obtained through finger prick and is intended for use at the point of care (e.g. HIV testing sites, clinics, doctor's office), thus a false negative result may have been given directly to a patient.

Health Canada is following up with the manufacturer with respect to the rapid serum and blood test kits, and will take further action if necessary.

Background on Fast-Check HIV-1/2 (serum) and Fast-Check HIV-1/2 (whole blood)

Health Canada licenced both kits in March 2000:

• The Fast-Check HIV-1/2 (serum) test is used to test human serum or plasma for antibodies to Human Immunodeficiency Virus (HIV). It is intended for laboratory use. This device is not intended for home use.

• The Fast-Check HIV-1/2 (whole blood) test is used to detect HIV antibodies in human blood. It is intended for rapid point of care testing by health care professionals and is to be used only in sites where appropriate HIV counselling by a health care professional is available. This device is not intended for home use. It is the only rapid test licenced in Canada for point of care or patient testing.

This advisory does not affect the safety of the blood supply. Canadian Blood Services and Hema-Quebec, the blood system operators, use different test kits to screen blood donations.

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Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189

Public Inquiries:
(613) 957-2991