A Low-cost In-house HIV Integrase Strand-Transfer Inhibitor Drug Resistance Test for Resource-limited Settings

HIV drug resistance (HIVDR) testing (DRT) is costly in nature and this limits its access in resource-limited settings. A cost-effective in-house integrase strand transfer inhibitor (INSTI) assay has been developed and we estimate the cost of offering this HIVDR test from a provider’s perspective. Ethical approval for this study was obtained from the Kenyatta National Hospital - University of Nairobi Ethics and Research Committee (KNH-UoN ERC); approval number P263/05/2020. An incremental ingredient costing approach was used to estimate the cost of reagents and consumables required to perform the HIVDR INSTI assay. Data was collected through time and motion study to identify and quantify inputs to the assay. Prices were abstracted from laboratory records including quotations, delivery notes and invoices. Cost data entry was done in Excel software (Microsoft, New York, USA). We used an Excel based model to compute the integrase assay unit cost. All costs were converted to US dollars 2020 (13^th September 1 US $= KES.108.54).人类免疫缺陷病毒耐药（HIV drug resistance, HIVDR）检测（DRT）本身成本高昂，这限制了其在资源匮乏地区的可及性。本研究已开发出一款具备成本效益的实验室内部整合酶链转移抑制剂（integrase strand transfer inhibitor, INSTI）检测方法，并从检测服务提供方的视角，估算了开展该HIVDR检测的成本。本研究已获得肯雅塔国家医院-内罗毕大学伦理与研究委员会（KNH-UoN ERC）的伦理审查批准，批准编号为P263/05/2020。本研究采用增量成分成本法，对开展HIVDR INSTI检测所需的试剂与耗材成本进行估算。通过时间与动作研究收集数据，以明确并量化该检测的各项投入要素。相关价格从实验室档案中提取，涵盖报价单、送货单及发票。成本数据录入工作通过Excel软件（Microsoft，美国纽约）完成。本研究采用基于Excel的模型计算整合酶检测的单位成本。所有成本均换算为2020年美元计价（2020年9月13日汇率：1美元=108.54肯尼亚先令）。