Establishment of molecular diagnostics for research requires high quality laboratory practices and validation of research methods by established laboratories. Amongst the objectives of the NIH funded H3Africa project at the African Collaborative Center for Microbiome and Genomics Research (ACCME), IHVN, Nigeria is molecular epidemiology of HPV infection.
Methods:Staff from ACCME-IHVN were trained in HPV genotyping technology using the SPF10 PCR-DEIA-LiPA25, version 1 at the DDL Diagnostic Laboratory, Netherlands after which participants enrolled in the ACCME study of persistent HPV infection and cervical cancer in Nigeria were tested. Accuracy of results was ensured by sharing with collaborators at DDL for review before certification. A quality control panel of 18 positive samples and 10 negative samples were selected from a pool of 90 samples tested in Abuja were sent to DDL for re-testing.
Results:The kappa statistic for agreement between detection of HPV genotypes by SPF10 DEiA in both laboratories was 0.85 (P < 0.001), 95% CI (0.66 to 1.05). All HPV negative sample results were concordant between both laboratories. Of the 18 samples used in the HPV Positive QC panel, 16 (88.8%) showed concordance of HPV genotypes, 1 (5.6%) showed compatibility for some but not all genotypes and 1 (5.6%) sample had discordant genotypes in both laboratories. Two of the 18 HPV positive samples in Nigeria tested negative at DDL. Of these 2, one was found positive for HPV 66 while the second sample had multiple HPV 45, 53, 70. Neither sample was genotyped for HPV at DDL. Of the 16 concordant HPV positive samples on DEIA, one sample was genotyped as type 52 in Nigeria but HPV X in Netherlands, while a second sample was genotyped as 40 in Nigeria but 40 and 58 in the Netherlands.
Significance:The capacity of African scientists to conduct high throughput scientific research can be enhanced through training but also requires long term mentoring by international collaborating laboratories.
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