A pilot behavioural and biological surveillance survey for HIV and other bloodborne infections among Aboriginal people in Regina, Saskatchewan.

BACKGROUND: Aboriginal people in Canada are disproportionately affected by HIV and other blood-borne infections. A-Track is a national public health surveillance system designed to monitor HIV and related infections, behaviours and socio-demographic factors among Aboriginal populations in Canada. The pilot survey for the A-Track surveillance system, the first of its kind in Canada, was conducted in Regina, Saskatchewan and implemented via a community and public health partnership. OBJECTIVE: To assess the prevalence of HIV, hepatitis C, syphilis and associated risk behaviours and socio-demographic factors among Aboriginal people in Regina, Saskatchewan. This focus of the pilot survey was to provide this surveillance information for public health action and to determine whether this type of public health surveillance activity could be conducted in an urban setting across Canada. METHODS: Survey participants were self-identified Aboriginal people (First Nations, Inuit or Métis) or those who claimed Aboriginal ancestry and between the ages of 16 and 60 years. These individuals were also asked to provide a blood sample for HIV, hepatitis C and syphilis antibody testing. Descriptive analyses were performed with sex-based comparisons. RESULTS: There were 1064 people who participated in the survey. Their average age was 33 years and 51% were male. The majority of participants (93%) lived in urban Regina at the time of the survey. Just over half (53.2%) of all participants had been removed from their families during childhood; 29.9% had lived in a residential or boarding school during childhood; and 57.7% had lived at some point in a correctional facility. Among the 1,045 participants who provided a blood sample of sufficient quantity for testing, 5.2% were HIV seropositive and 55.8% of these were aware of their HIV status. The lifetime exposure to hepatitis C was 41.6%, with significantly higher proportions of males than females testing positive for hepatitis C exposure. Syphilis seroprevalence was very low (<1%). Almost three-quarters (71.5%) of participants reported being tested for HIV at least once in their lifetime and among those ever tested, 67.6% had been tested during the 12 months prior to the interview. CONCLUSION: Aboriginal people are disproportionately affected by the HIV/AIDS epidemic in Canada. The findings from the A-Track pilot survey can be used to inform and evaluate prevention and treatment services for HIV and other related infections among Aboriginal people. Lessons learned from the pilot survey could also be used to guide the possible implementation of A-Track in other urban and/or reserve locations in Canada.

Key findings from a national enhanced HIV surveillance system: 2010 - 2012.

BACKGROUND: People who inject drugs represent an important risk group in Canada's HIV epidemic. I-Track is a national public health surveillance system designed to monitor HIV and hepatitis C prevalence and associated risk behaviour factors among people who inject drugs in Canada. Information is collected through cross-sectional surveys conducted periodically at sentinel sites across Canada. I-Track Phase 3 was conducted between April 26, 2010 and August 7, 2012 across 11 participating sentinel sites. OBJECTIVE: To assess the prevalence of HIV, lifetime exposure to hepatitis C and associated risk behaviours among people who inject drugs in Canada to guide and help evaluate HIV and hepatitis C prevention, treatment and control activities. METHODS: People who had injected drugs in the six months prior to the interview and who met the minimum age of consent participated in an interviewer administered survey and provided a blood sample for HIV and hepatitis C antibody testing. Descriptive analyses were performed with sex-based comparisons. RESULTS: There were 2,687 people who participated in the survey. 68.2% were male, 60.9% were between the ages of 30 and 49 years and 36.2% self-identified as Aboriginal. Among the participants who provided a blood sample of sufficient quantity for testing, 11.2% were HIV seropositive and their lifetime exposure to hepatitis C infection was 68.0%. Drugs commonly injected included cocaine (64.3%), hydromorphone (47.2%), non-prescribed morphine (47.0%), oxycodone (37.7%) and heroin (26.7%). Injecting with previously used needles and/or other injection equipment was reported by 15.5% and 34.5% of participants, respectively. Just over one-third reported having two or more sex partners in the six months prior to the interview (34.4%) and using a condom at last sex (36.6%). The majority of participants had tested at least once in their lifetime for HIV or hepatitis C (92.9% and 91.4%, respectively). A large proportion of the participants who reported being HIV positive were under the care of a doctor (95.0%) and nearly two-thirds were taking medications prescribed for their HIV infection at the time of the interview (66.0%). CONCLUSION: HIV seroprevalence and lifetime exposure to hepatitis C infection were high among I-Track Phase 3 participants. Although many participants reported safe injection and safe sexual practices, a high proportion of participants reported risk behaviours associated with acquisition and transmission of HIV and hepatitis C. People who inject drugs continue to represent an important risk group in Canada's HIV epidemic and the I-Track Phase 3 survey findings highlight the need for continued treatment and prevention services, as well as routine and integrated testing among people who inject drugs.

Comparative evaluation of the Bio-Rad Geenius HIV-1/2 Confirmatory Assay and the Bio-Rad Multispot HIV-1/2 Rapid Test as an alternative differentiation assay for CLSI M53 algorithm-I.

INTRODUCTION: The CLSI-M53-A, Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus (HIV) Infection; Approved Guideline includes an algorithm in which samples that are reactive on a 4th generation EIA screen proceed to a supplemental assay that is able to confirm and differentiate between antibodies to HIV-1 and HIV-2. The recently CE-marked Bio-Rad Geenius HIV-1/2 Confirmatory Assay was evaluated as an alternative to the FDA-approved Bio-Rad Multispot HIV-1/HIV-2 Rapid Test which has been previously validated for use in this new algorithm. METHODS: This study used reference samples submitted to the Canadian - NLHRS and samples from commercial sources. Data was tabulated in 2×2 tables for statistical analysis; sensitivity, specificity, predictive values, kappa and likelihood ratios. RESULTS: The overall performance of the Geenius and Multispot was very high; sensitivity (100%, 100%), specificity (96.3%, 99.1%), positive (45.3, 181) and negative (0, 0) likelihood ratios respectively, high kappa (0.96) and low bias index (0.0068). The ability to differentiate HIV-1 (99.2%, 100%) and HIV-2 (98.1%, 98.1%) Ab was also very high. CONCLUSION: The Bio-Rad Geenius HIV-1/2 Confirmatory Assay is a suitable alternative to the validated Multispot for use in the second stage of CLSI M53 algorithm-I. The Geenius has additional features including traceability and sample and cassette barcoding that improve the quality management/assurance of HIV testing. It is anticipated that the CLSI M53 guideline and assays such as the Geenius will reduce the number of indeterminate test results previously associated with the HIV-1 WB and improve the ability to differentiate HIV-2 infections.

Would CLSI M53-A have helped in the diagnosis of HIV in Canada? Results of the performance of Canadian laboratories participating in a recent NLHRS proficiency testing panel containing HIV-1 antigen positive (antibody negative) and HIV-2 samples.

INTRODUCTION: The Clinical and Laboratory Standards Institute recently published M53-A, Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus (HIV) Infection; Approved Guideline (2011), which includes a state of the art algorithm for identifying HIV-1 acute and HIV-2 infections. To assess the ability of Canadian laboratories to detect these sample types and the impact of M53-A, the National Laboratory for HIV Reference Services distributed a special proficiency testing panel. METHODS: HIVS425-2012Nov22 was sent to 42 laboratories across Canada. It contained one HIV negative sample (B), two HIV-1 positive samples (A and E), one HIV-2 positive sample (C) and one HIV-1/2 antibody negative-HIV-1 antigen positive sample (D). Data was collected and analyzed using DigitalPT; a standardized on-line tool. RESULTS: Forty-one laboratories returned results. Sample B (HIV negative) was identified by 95% of laboratories (39/41) and samples A and E (HIV-1 positive) by 98% (40/41). No laboratory identified sample C as HIV-2 positive, although 85% (35/41) detected reactivity prompting a referral for further testing. The remaining laboratories identified sample C as HIV-1 positive (4), indeterminate (1) or gave no final status (1). Sample D (HIV antibody negative-antigen positive) was correctly identified by two laboratories as HIV-1 antigen positive while 78% (32/41) detected reactivity, recommending further testing. One laboratory did not provide a final status. Alarmingly, six laboratories called this sample HIV negative. CONCLUSION: Although there is a high quality of HIV testing across Canada, introduction of the M53-A guideline would further improve the ability of laboratories to diagnose HIV-1 acute and HIV-2 infection.

Identification of performance problems in a commercial human immunodeficiency virus type 1 enzyme immunoassay by multiuser external quality control monitoring and real-time data analysis.

In June 2005, a pilot program was implemented in Canadian laboratories to monitor the performance of the Abbott human immunodeficiency virus types 1 and 2 (HIV-1/2) gO enzyme immunoassay (EIA). Two different external quality control (QC) reagents and a "real-time" software analysis program were evaluated. In November 2005, higher-than-expected calibrator rate values in these kits were first reported at the Ontario Ministry of Health (Etobicoke), followed by the Alberta Provincial Public Health Laboratory (Edmonton and Calgary) and others. These aberrations were easily and readily tracked in "real time" using the external QC reagents and the software program. These high calibrator values were confirmed in Delkenheim, Germany, by Abbott, and a manufacturing change was initiated beginning with lot 38299LU00, which was distributed to laboratories in Canada in April 2006. However, widespread reports of calibrator failure by laboratories outside Canada were made in March 2006. In April 2006, Abbott Diagnostics initiated a level III investigation to identify the root cause, which was prolonged storage, under uncontrolled storage conditions, of the raw material used in the manufacture of the matrix cells. To the best of our knowledge, this is the first example of a program in Canada for serological testing that combines a common external QC reagent and a "real-time" software program to allow laboratories to monitor kit performance. In this case, external QC monitoring helped identify and confirm performance problems in the Abbott HIV-1/2 gO EIA kit, further highlighting the benefit of implementing such a program in a national or multilaboratory setting for laboratories performing diagnostic and clinical monitoring testing.