Evaluation of the DBS versus plasma sample with HCV testing using ELISA and RDT diagnostic methods at Ethiopian National Blood Bank Service, St.Peter Hospital, Yekatit 12 Hospital, CBE Clinic and St. Paulo’s Hospital Millennium Medical College Addis Ababa, Ethiopia.
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Date
2023-06
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Addis Ababa University
Abstract
Back ground: One of the numerous diseases that the HCV can cause is cancer. It is a significant public
health issue that has a global impact on millions of people's lives, with majority from sub-saharan African
countries. Laboratory diagnosis of HCV mainly done by using ELISA, and Rapid diagnostic test methods
by using plasma/serum samples. However, most laboratories do not have the facilities & so forced either
to submit patients in the far referral laboratories or empirically treat patients. Thus, as alternative
solutions, other places worldwide used dry blood sample techniques to collect sample & submit for
laboratory tests. However, such DBS approaches not well known in our country.
Objective: To evaluate the DBS versus plasma sample with HCV testing using ELISA and RDT
diagnostic methods at Ethiopian National Blood Bank, St.Peter Hospital, Yekatit 12 Hospital, CBE
Clinic, and St. Paulo’s Hospital Millennium Medical College, Addis Ababa, Ethiopia.
Methods: Cross-sectional investigation were used to detect the effectiveness of DBS using whole
blood in the (ELISA-INNOTEST hepatitis virus Ab IV) compared to the serum/plasma sample
with RDT (wondfo) tests for the detection of HCV antibody . Data was collected by a check list. 159
HCV negative and 159 HCV positive venous plasma samples and 159 HCV negative and 159 HCV
positive whole blood was tested with the standard INNOTEST HCV Ab IV assay and RDT(Rapid
diagnostic test).
Results: A total of 318 individuals were participated. Participants age range of the study were 18 to 62,
whereas, the DBS sample HCV test result using ELISA & RDT tests were 159 positive,159 negative and
156 positive,162 negative respectively. The sensitivity, specificity, PPV, NPV and efficacy of DBS
versus ELSA& RDT were 100%, 99.4%, 99.4%, 100%, 98.7%, 99.4%, 98.7%, 99.4%. The test result
correlation agreement between of DBS among ELSA & DBS-RDT was 0. 969 & 0. 963 respectively.
Conclusions recommendation: The INNOTEST® HCV Ab IV assay performance using DBS
was acceptable, WHO recommend that, sensitivity for detection of antibodies to HCV was 98%
and specificity 99%, thus DBS may be used as a substitute sample type in cases when venous
blood collection is not feasible.
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Keywords
DBS, HCV, sensitivity, specificity, PPV and NPV