Background: Trinity Biotech Uni-GoldTM Malaria Ag P.f./PAN is a new rapid test for the detection of Malaria Pf/PAN antigens. The objective of this study was to assess the sensitivity, specificity, positive and negative predictive values of new rapid Uni-GoldTM Malaria Ag P.f./PAN rapid kit in comparison to the Gold Standard Microscopy in four malaria epidemiological zones of Kenya.
Methods: This study was carried out in the four Malaria Epidemiological zones in Kenya: Lake Endemic Zone – Nyanza (Ahero Sub county Referral Hospital), Highland Epidemic Zone - Rift Valley (Kapsabet County Referral Hospital), Seasonal arid/Semi-arid – Northern (Isiolo County Referral Hospital) and Low Risk Zone - Central Kenya (Nyeri County Referral Hospital). A total of 400 suspected malaria patient blood samples was tested on the Uni-GoldTM Malaria Ag P.f./PAN, Gold Standard Microscopy and SD BIOLINE malaria rapid diagnosis.
Results: Thirty nine of the 400 study participants (9.8%) were positive for plasmodium species by Giemsa Malaria microscopy. The parasite density ranged from 40 to 98,208 parasites /µl. A density of <200 parasites/µl was defined as weak positive, accounting for (4)10.2% .Thirty five (89.7%) had a parasite density of >200 parasites/µl. The sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for the Uni-GoldTM Malaria Ag P.f./PAN was 94.8%,97.2%,80.8% and 99.4% respectively for testing Plasmodium spp. While SD BIOLINE Malaria Ag P.f/Pan showed sensitivity, specificity, PPV and NPV Negative Predictive Value of 92.3%, 96.4%, 75.9%, and 99.0% respectively. The two malaria rapid diagnostic test kits showed an excellent strength of agreement with the Gold standard
Conclusion: The sensitivity of Uni-goldTM Malaria Ag Pf/Pan is 94.8%. The kit also showed an excellent agreement of 97.2% with malaria microscopy. Therefore the Uni-GoldTM Malaria Ag P.f./PAN can be used as an alternative to limitations of microscopy diagnosis.