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Costing and cost-effectiveness of Cepheid Xpert HIV -1 Qual Assay using whole blood protocol versus PCR by Abbott
Maggie Nyirenda-Nyang'wa1,2,3, Gerald Manthalu4, Matthias Arnold5,6
1University College London, London, UK.
Insights
Point-of-care testing (POCT) for HIV using the Cepheid Xpert HIV-1 Qual assay (XpertHIV) is more cost-effective and faster than traditional PCR testing. This rapid HIV diagnosis in infants can improve health outcomes and reduce healthcare costs in Malawi.
Area of Science:
- Public Health
- Infectious Disease Diagnostics
- Health Economics
Background:
- Timely diagnosis of HIV in infants is critical, with 40,000 infants annually exposed in Malawi.
- Current gold standard polymerase-chain-reaction (PCR) testing has long turnaround times (2-3 months), leading to loss to follow-up.
- Point-of-care testing (POCT) offers a potential solution to reduce diagnostic delays and improve cost-effectiveness.
Purpose of the Study:
- To assess the cost-effectiveness of the Cepheid Xpert HIV-1 Qual assay whole blood (XpertHIV) POCT compared to traditional PCR testing for infant HIV diagnosis in Malawi.
- To evaluate the impact of XpertHIV on diagnostic turnaround time (TAT) and associated patient costs.
Main Methods:
- A cost-minimisation and cost-effectiveness analysis comparing XpertHIV and PCR was conducted.
- 700 PCR tests and XpertHIV tests were performed on 680 participants.
- Societal perspective costs were explored through interviews with 200 caregivers, with TAT as the primary outcome measure.
Main Results:
- XpertHIV was cost-minimising at $42.34 per test versus $66.66 for PCR during the study period.
- Annual cost-minimisation favored XpertHIV ($16.12/test) over PCR ($27.06/test).
- XpertHIV demonstrated a significantly shorter mean TAT (7.10 hours) compared to PCR (153.15 hours), with patient costs at $2.45 per test.
Conclusions:
- POCT XpertHIV is a cost-saving diagnostic strategy compared to PCR.
- Adopting XpertHIV can lead to significant annual savings for Malawi and improve patient outcomes through prompt HIV care.
- The study provides preliminary evidence supporting the national adoption of XpertHIV for infant HIV diagnosis.
Background:
Timely diagnosis of HIV in infants and children is an urgent priority. In Malawi, 40,000 infants annually are HIV exposed. However, gold standard polymerase-chain-reaction (PCR) based testing requires centralised laboratories, causing turn-around times (TAT) of 2 to 3 months and significant loss to follow-up. If feasible and acceptable, minimising diagnostic delays through HIV Point-of-care-testing (POCT) may be cost-effective. We assessed whether POCT Cepheid Xpert HIV-1 Qual assay whole blood (XpertHIV) was more cost-effective than PCR.
Methods:
From July-August 2018, 700 PCR Abbott tests using dried blood spots (DBS) were performed on 680 participants who enrolled on the feasibility, acceptability and performance of the XpertHIV study. Newly identified HIV-positive We conducted a cost-minimisation and cost-effectiveness analysis of XpertHIV against PCR, as the standard of care. A random sample of 200 caregivers from the 680 participants had semi-structured interviews to explore costs from a societal perspective of XpertHIV at Mulanje District Hospital, Malawi. Analysis used TAT as the primary outcome measure. Results were extrapolated from the study period (29 days) to a year (240 working days). Sensitivity analyses characterised individual and joint parameter uncertainty and estimated patient cost per test.
Results:
During the study period, XpertHIV was cost-minimising at $42.34 per test compared to $66.66 for PCR. Over a year, XpertHIV remained cost-minimising at $16.12 compared to PCR at $27.06. From the patient perspective (travel, food, lost productivity), the cost per test of XpertHIV was $2.45. XpertHIV had a mean TAT of 7.10 hours compared to 153.15 hours for PCR. Extrapolates accounting for equipment costs, lab consumables and losses to follow up estimated annual savings of $2,193,538.88 if XpertHIV is used nationally, as opposed to PCR.
Conclusions:
This preliminary evidence suggests that adopting POCT XpertHIV will save time, allowing HIV-exposed infants to receive prompt care and may improve outcomes. The Malawi government will pay less due to XpertHIV's cost savings and associated benefits.

