Trinity Biotech Fingerstick whole blood sample for HIV OTC test Presented by; Fiona Campbell.

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Presentation transcript:

Trinity Biotech Fingerstick whole blood sample for HIV OTC test Presented by; Fiona Campbell

Trinity experience with rapid HIV testing Commercializing HIV rapid tests internationally for more than 12 years In the last year alone over 7 million persons have been tested for HIV by Trinity Biotech Plc. rapid HIV products Different test formats Varied users and applications

UniGold TM Recombigen HIV PMA approval 23 rd December 2003 Approved for use with serum, plasma and whole blood (fingerstick and venipuncture) CLIA waived for venipuncture whole blood and fingerstick whole blood

User experience with Fingerstick Whole Blood Glucose monitoring, Cholesterol monitoring, Hemoglobin, Lactic acid, Triglycerides FDA approved HIV home test (Home Access) Low virus viability ex-vivo Safe disposal of bloods can be easily achieved Sealed disposal containers Sterile disinfectant wipes Retractable safety lancet

Ease of Use Procedure Read instructions Clean finger – sterile wipe Prick finger – retractable safety lancet Take blood sample - measured capillary tube Add blood to device Add buffer x 4 drops Wait 10 minutes Interpret result Dispose of materials

User Safety Mechanisms 2 built in controls Sample addition Test functionality

Test Principals and Performance data Third-generation, antigen sandwich format Allows for earlier detection of antibodies during sero- conversion phase Sensitivity (whole blood samples) 100% 1032/ % C.I. = % Specificity (whole blood samples) Prevalence >1% 99.8% (95% C.I %) Prevalence <1% 99.7% (95% C.I %) Sero conversion and low titre panels The UniGold test showed comparable sensitivity to the most sensitive FDA licensed EIA tests.

CLIA waiver data / Untrained user Testing of blinded panel 100 untrained subjects at 3 sites Interpretation of picture cards 60 untrained subjects interpreted 8 pictures Flex / tolerance studies both in house and external studies

Summary OTC use with whole blood is established The UniGold TM Recombigen HIV is a suitable format for OTC use Trinity Biotech is committed to supporting international use of HIV rapid tests.