Sensitivity assessment of the modified ABAcard® HemaTrace® and p30 immunochromatographic test cards

IF 2.2 3区 医学 Q1 MEDICINE, LEGAL Forensic science international Pub Date : 2024-09-19 DOI:10.1016/j.forsciint.2024.112234
Felicia Bardan , Duncan Taylor , Julianne Henry
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Abstract

Operational forensic laboratories routinely perform immunological assays for detecting various body fluids. The ABAcard® p30 and HemaTrace® immunochromatographic tests from Abacus Diagnostics are used for detecting the p30 enzyme in human semen and human haemoglobin present in blood respectively. In early 2023, manufacturer modifications to the ABAcard® p30 and HemaTrace® tests resulted in a reduction in card size and volume of sample extract used in the recommended protocol. This change in card design and/or the reduced volume of sample extract may alter the sensitivity of the test. This study established and compared the limit of detection (LOD) for the old and newly modified ABAcard® p30 and HemaTrace® test cards. The LOD values showed that the new test cards were approximately 2.4-fold (HemaTrace® test) and 3.4-fold (p30 test) more sensitive than the old cards. Additionally, it was found that the new HemaTrace® test cards were more susceptible to the high dose hook effect. In response to the increased sensitivity, existing data pertaining to the reactivity of these test cards to non-target body fluid and substances warrants re-investigation to ensure positive results are interpreted correctly.

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改良版 ABAcard® HemaTrace® 和 p30 免疫层析检测卡的灵敏度评估
法医实验室经常使用免疫测定来检测各种体液。Abacus Diagnostics 公司的 ABAcard® p30 和 HemaTrace® 免疫层析检测试剂盒分别用于检测人类精液中的 p30 酶和血液中的人类血红蛋白。2023 年初,生产商对 ABAcard® p30 和 HemaTrace® 检测卡进行了修改,导致检测卡尺寸和推荐方案中使用的样本提取物量减少。检测卡设计的改变和/或样本提取物体积的减少可能会改变检测的灵敏度。本研究确定并比较了旧版 ABAcard® p30 和新改版 HemaTrace® 检测卡的检测限 (LOD)。检测限值显示,新检测卡的灵敏度比旧检测卡分别高出约 2.4 倍(HemaTrace® 检测)和 3.4 倍(p30 检测)。此外,还发现新的 HemaTrace® 检测卡更容易受到高剂量钩效应的影响。鉴于灵敏度的提高,需要重新调查与这些检测卡对非目标体液和物质的反应性有关的现有数据,以确保正确解释阳性结果。
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来源期刊
Forensic science international
Forensic science international 医学-医学:法
CiteScore
5.00
自引率
9.10%
发文量
285
审稿时长
49 days
期刊介绍: Forensic Science International is the flagship journal in the prestigious Forensic Science International family, publishing the most innovative, cutting-edge, and influential contributions across the forensic sciences. Fields include: forensic pathology and histochemistry, chemistry, biochemistry and toxicology, biology, serology, odontology, psychiatry, anthropology, digital forensics, the physical sciences, firearms, and document examination, as well as investigations of value to public health in its broadest sense, and the important marginal area where science and medicine interact with the law. The journal publishes: Case Reports Commentaries Letters to the Editor Original Research Papers (Regular Papers) Rapid Communications Review Articles Technical Notes.
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