Description
Introduction
Cervical cancer remains a major public health threat in Kenya, with 5,845 new cases and 3,591 deaths reported in 2022. Human Papillomavirus (HPV) is the principal cause of cervical cancer, responsible for more than 99% of cases. World Health Organization (WHO) recommends HPV testing as the gold standard for screening women of reproductive age (18–49 years). Quality assurance in HPV testing is critical to guarantee accuracy of laboratory results and promote correct diagnosis.
Method
In 2024, quality audit was conducted in 27 HPV testing laboratories across 16 counties. Facilities were selected based on HPV testing workload and subscription to HPV proficiency scheme. The audit assessed equipment functionality, adherence to standard procedures, availability of essential commodities, and data management practices. External Quality Assurance (EQA) performance was evaluated using the most recent cycle results, with a score ≥80% classified as satisfactory.
Results
Of the 27 laboratories, 85% (23/27) submitted EQA results online, 59% (16/27) completed all testing cycles, and 70% (19/27) achieved satisfactory performance and 26% (7/27) forwarded samples to the national oncology reference laboratory for validation. Data management showed that 71% (20/27) uploaded monthly HPV reports to the Kenya Health Information System (KHIS), while only 37% (10/27) had Laboratory Information Management Systems (LIMS) installed. Service delivery was frequently disrupted by HPV cartridge stockouts, reported in 89% (24/27) of facilities. Furthermore, 37% (10/27) had Standard Operating Procedures and HPV registers, while job aids and request forms were available in 26% (7/27) and 19% (5/27), respectively.
Conclusion
All operational HPV platforms had valid service contracts, and most laboratories submitted statistics to the national system. Frequent reagent shortages and limited LIMS coverage remain major challenges. Strengthening resource pooling, expanding mentorship, and enhancing technical support will improve compliance with testing procedures and validation. Initiating ISO-15189 accreditation will further standardize HPV testing services nationwide.
| Country | Kenya |
|---|---|
| Organization | Government of Kenya |
| Position | Program Officer |
| Received a Grant? | No |
