On August 22, 2024, the Delegate of Public Health for the Littoral Region, Dr. Bidjang Robert Mathurin, issued a critical directive (Reference: 0807/NS/MINSANTE/DRSPL/BCASS/CN3/PFPV) addressing District Officers, District Vigilance Focal Points, Heads of Health Institutions, and Health Institution Stock Managers.
The directive mandates the immediate withdrawal of specific lots of Determine HIV1/2 test reagents due to reports of false positive results. The affected test lots are:
Lot No.: 0000713179, Expiry Date: 26/09/2024
Lot No.: 0000734283, Expiry Date: 11/09/2024
Lot No.: 0000815407, Expiry Date: 30/04/2025
Action Required:
All health institutions, district officers, district vigilance focal points, and stock managers are instructed to immediately withdraw these batches from their facilities. Dr. Bidjang emphasized,
I would be grateful if you could immediately withdraw the Determine tests with the above batch numbers from the respective health facilities for which you are responsible.” He further urged health professionals to, “step up your vigilance with regard to any other batches that may have a functional quality defect, and to notify the authorities immediately.
This withdrawal should follow the conventional return procedure, with a duly signed returns form submitted to the respective health district offices.
Attention National Stakeholders:
While this alert specifically addresses the Littoral Region, it is crucial for laboratory professionals and their hierarchies nationwide to be aware that the affected test lots could be present anywhere in the national territory. Vigilance is paramount to prevent the distribution and use of these faulty tests in any region.
Background:
The Determine HIV1/2 test has been a first-line test in Cameroon’s National Algorithm for many years. However, it was recently replaced in the new three-serial testing algorithm as announced by the Minister of Public Health. We anticipate that this test will be gradually phased out of the health system.
The Role of Laboratory Professionals:
Laboratory professionals are the front-line users of these tests, making their role in this process critical. Respecting quality assurance in all testing processes is essential to ensure accurate results and maintain public trust. Vigilance is a key responsibility in safeguarding the quality of diagnostic tests and the health of patients.
Impact of False Positive Results:
The occurrence of false positive results from these tests can have severe negative impacts at various levels:
The Patient or Hospital User:False positive results can cause significant psychological distress for patients, leading to unnecessary anxiety, depression, and stigma. Patients may also undergo inappropriate treatment, which could have further negative health consequences and strain their relationships and social standing.
The Laboratory Staff: Laboratory professionals may face increased workloads as they try to manage and correct these errors. Repeated incidents can lead to a loss of trust from patients and colleagues, damaging their professional credibility and leading to potential legal liabilities.
The Health Institution: Health institutions risk severe reputational damage when false positive results are reported. The credibility of the institution is at stake, potentially leading to a decrease in patient trust and engagement. Legal challenges may arise from affected patients, resulting in financial and operational impacts.
The Health System and National Reputation: On a broader scale, repeated instances of false positive results undermine the integrity of the entire health system. Public trust in healthcare services is eroded, and the country’s reputation in managing public health issues may suffer on the international stage, potentially affecting cooperation with global health partners.
Together, we can ensure a safer and more reliable health system for all.
Thank you for your continued dedication to quality and patient safety.
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