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QASI-VL (Quality Assessment and Standardization of Indicators Relevant to HIV/AIDS – Viral Load)

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Details

Pathogen:
Human immunodeficiency virus (HIV)
Laboratory:
National Laboratory for HIV Immunology
Phone #:
(204) 789-6477
Fax:
(204) 318-2221
Email:
Frequency:
Bi-annual
Description:

QASI, the Public Health Agency of Canada’s International Program for Quality Assessment and Standardization of Indicators relevant to HIV/AIDS is located at the National HIV and Retrovirology Laboratories in Winnipeg, Canada. QASI provides external quality assurance (EQA) through administration of proficiency testing (PT) panels and comprehensive corrective and preventative action as required in English, French and Spanish. There are three EQA programs currently available; QASI-LI (Leukocyte Immunophenotyping), QASI-EID (Early-Infant Diagnosis) and QASI-VL (Viral Load).

QASI-VL was launched in March 2019 with the mandate to provide EQA specifically to near-care and future point-of-care (POC) testing sites in resource-limited countries performing viral load monitoring using new rapid viral nucleic acid quantitation technologies. Quantitating the amount of virus (viral load) in a patient’s blood is used to monitor the effectiveness of anti-retroviral treatments (ART). Increases in VL serve as an early warning sign of treatment failure or non-adherence to an ART regimen. Early detection through routine VL testing can significantly improve clinical outcomes and reduce the occurrence of drug resistant mutations. 

The program is designed to work through in-country Coordinators, who re-distribute panels, collect and enter results on behalf of Participants into the QASI online database. Documentation is provided to assist both Coordinators and Participants with this process. QASI provides feedback in the form of individual Performance Reports for each POC testing site, and a comprehensive Assessment Report for Coordinators, which details overall performance, non-conformances, and recommended corrective actions as required. The ultimate goal is to assist a Coordinator in developing and launching a national EQA program for POC HIV VL in their own country. 

Frequency of distribution: QASI-VL will operate on a bi-annual testing scheme, providing 3 specimens per session, and initially will service only the near-care device; Cepheid GeneXpert, and the m-PIMA device. To replicate clinical plasma specimens, the proficiency testing specimens consists of TE-buffer spiked with heat-inactivated HIV cell culture.  Panels will represent a range of HIV viral loads in order to test the participant’s proficiency, and the POC instrument’s reliability, for quantitatively detecting HIV RNA. Quantitative results will be compiled and statistically analyzed for accuracy.

Scope:

To ensure accurate and reliable point-of-care testing for HIV viral load monitoring through the provision of proficiency testing panels, external quality oversight and comprehensive corrective and preventative action recommendations in countries where EQA services are limited or unavailable.

Fees:

There is no fee to enrol or participate in the QASI-VL program.

Eligibility criteria for participation:

Eligible participants are those sites actively performing viral load testing using the Cepheid GeneXpert or m-PIMA (formerly Alere q) technologies. This criteria will expand to include future POC technologies as they come to market.

Confidentiality arrangements:

Confidentiality of testing results and performance is maintained using a password protected online database and numerical laboratory IDs to distinguish testing sites.

How to apply:

Please contact qasi@phac-aspc.gc.ca to apply for any of our EQA programs.