Establish a reference standard for HIV Screening with the use of ELISA from finger stick blood sampled on DBS filter paper

The Division of Medical Informatics in collaboration with Division of Infectious Diseases and Swasti Health Resource Centre is validating the use of dried blood spot for ELISA against venepuncture. It is well acknowledged that lay provider community based HIV screening with the use of rapid tests is a very promising method to reach people who are currently not reached with HIV Testing Services. The large differences in the performance of these testing models require for a reference method that can be used for validation of these testing models and for quality control. Taking venepuncture samples in the field and transporting these to a laboratory for an ELISA on serum is not a feasible solution, even though this is the current gold standard. A cold chain would be required and a medical professional would have to take the venepuncture sample. For this reason, a more feasible solution is proposed, the use of DBS to sample finger stick blood. DBS samples can easily be obtained by non-medical professionals who have received training. The dried DBS samples can be sent to the laboratory for detection of antibodies by ELISA. To establish this alternative reference standard, we have to compare this (DBS) with the current gold standard, an ELISA from the serum of a venepuncture blood sample. To compare these results, both the samples have to be taken from the same individual at the same time. Other alternatives that are less invasive for the participants have been discussed and are not feasible.

This study would assess the accuracy, prediction, sensitivity and specificity of ELISA on a DBS sample in comparison to a venepuncture sample. Once these parameters are assessed, the benefits of DBS can be demonstrated against a standard test.