Iza Ciglenecki, Nombuso Ntshalintshali, Esther Mukooza, Skinner Lekelem, Mpumelelo Mavimbela, Sindisiwe Dlamini, Lenhle Dube, Nomvuyo Mabuza, Melat Haile, Tom Ellman, Antonio Flores, Olivia Keiser, Sindy Matse, Roberto de la Tour, Alexandra Calmy, Bernhard Kerschberger
{"title":"第四代抗原/抗体HIV快速诊断试验的低敏感性决定™HIV早期检测在斯瓦蒂尼农村护理点检测急性HIV感染：诊断准确性研究","authors":"Iza Ciglenecki, Nombuso Ntshalintshali, Esther Mukooza, Skinner Lekelem, Mpumelelo Mavimbela, Sindisiwe Dlamini, Lenhle Dube, Nomvuyo Mabuza, Melat Haile, Tom Ellman, Antonio Flores, Olivia Keiser, Sindy Matse, Roberto de la Tour, Alexandra Calmy, Bernhard Kerschberger","doi":"10.1002/jia2.26517","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Introduction</h3>\n \n <p>The diagnosis of acute HIV infection (AHI) is challenging in routine settings because it cannot be detected by routine third-generation antibody rapid diagnostic tests (RDTs). The current fourth-generation antibody/antigen RDT, Determine™ HIV Early Detect, has demonstrated high sensitivity in laboratory studies, but field evaluations at the point of care are lacking. We nested a diagnostic accuracy study within a larger study of the burden of sexually transmitted infections in rural Eswatini.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Adults were enrolled at six routine HIV testing sites (HTS) in the Shiselweni region between June 2022 and April 2023. Determine™ HIV Early Detect was performed by HTS counsellors in parallel with routine HIV testing using a finger-prick blood sample. The reference test was HIV viral load (VL) in the plasma sample, performed on the Xpert platform in the central laboratory. AHI was defined as a negative or discordant HIV test result according to the national serial RDT algorithm and an HIV VL >10,000 copies/ml, or two consecutive HIV VL measurements between the lower limit of detection (40 copies/ml) and 10,000 copies/ml. Established HIV infection was defined as a positive serial RDT test, and overall HIV infection as either established HIV infection or AHI.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>One thousand one hundred and sixty-three participants had all test results available; 49 (4.2%) were diagnosed with HIV (39 with established HIV according to the serial RDT algorithm and 10 with AHI). AHI prevalence among participants with HIV negative or discordant routine RDT results was 0.9% (10/1124). The sensitivity of Determine™ HIV Early Detect to detect overall HIV infection was 83.7% (95% CI 70.3–92.7) and to detect AHI was 20% (95% CI 2.5–55.6%); the specificity was equally high for both 99.8% (95% CI 99.4–100).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>The low sensitivity of Determine™ HIV Early Detect to detect AHI when performed at the point of care using finger-prick blood samples in our study contrasts with other published evaluations from laboratory settings and highlights the importance of field evaluations of the commonly used diagnostic tests.</p>\n </section>\n </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 7","pages":""},"PeriodicalIF":4.9000,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26517","citationCount":"0","resultStr":"{\"title\":\"Low sensitivity of the fourth-generation antigen/antibody HIV rapid diagnostic test Determine™ HIV Early Detect for detection of acute HIV infection at the point of care in rural Eswatini: a diagnostic accuracy study\",\"authors\":\"Iza Ciglenecki, Nombuso Ntshalintshali, Esther Mukooza, Skinner Lekelem, Mpumelelo Mavimbela, Sindisiwe Dlamini, Lenhle Dube, Nomvuyo Mabuza, Melat Haile, Tom Ellman, Antonio Flores, Olivia Keiser, Sindy Matse, Roberto de la Tour, Alexandra Calmy, Bernhard Kerschberger\",\"doi\":\"10.1002/jia2.26517\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Introduction</h3>\\n \\n <p>The diagnosis of acute HIV infection (AHI) is challenging in routine settings because it cannot be detected by routine third-generation antibody rapid diagnostic tests (RDTs). The current fourth-generation antibody/antigen RDT, Determine™ HIV Early Detect, has demonstrated high sensitivity in laboratory studies, but field evaluations at the point of care are lacking. We nested a diagnostic accuracy study within a larger study of the burden of sexually transmitted infections in rural Eswatini.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>Adults were enrolled at six routine HIV testing sites (HTS) in the Shiselweni region between June 2022 and April 2023. Determine™ HIV Early Detect was performed by HTS counsellors in parallel with routine HIV testing using a finger-prick blood sample. The reference test was HIV viral load (VL) in the plasma sample, performed on the Xpert platform in the central laboratory. AHI was defined as a negative or discordant HIV test result according to the national serial RDT algorithm and an HIV VL >10,000 copies/ml, or two consecutive HIV VL measurements between the lower limit of detection (40 copies/ml) and 10,000 copies/ml. Established HIV infection was defined as a positive serial RDT test, and overall HIV infection as either established HIV infection or AHI.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>One thousand one hundred and sixty-three participants had all test results available; 49 (4.2%) were diagnosed with HIV (39 with established HIV according to the serial RDT algorithm and 10 with AHI). AHI prevalence among participants with HIV negative or discordant routine RDT results was 0.9% (10/1124). The sensitivity of Determine™ HIV Early Detect to detect overall HIV infection was 83.7% (95% CI 70.3–92.7) and to detect AHI was 20% (95% CI 2.5–55.6%); the specificity was equally high for both 99.8% (95% CI 99.4–100).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>The low sensitivity of Determine™ HIV Early Detect to detect AHI when performed at the point of care using finger-prick blood samples in our study contrasts with other published evaluations from laboratory settings and highlights the importance of field evaluations of the commonly used diagnostic tests.</p>\\n </section>\\n </div>\",\"PeriodicalId\":201,\"journal\":{\"name\":\"Journal of the International AIDS Society\",\"volume\":\"28 7\",\"pages\":\"\"},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2025-06-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26517\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the International AIDS Society\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/jia2.26517\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the International AIDS Society","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jia2.26517","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
急性HIV感染（AHI）的诊断在常规环境中具有挑战性，因为它无法通过常规的第三代抗体快速诊断试验（RDTs）检测到。目前的第四代抗体/抗原RDT，即det™HIV早期检测，在实验室研究中显示出高灵敏度，但缺乏护理点的现场评估。我们在对斯瓦蒂尼农村地区性传播感染负担的大型研究中嵌套了一项诊断准确性研究。方法于2022年6月至2023年4月在Shiselweni地区的6个常规HIV检测点（HTS）招募成人。确定™HIV早期检测由HTS辅导员进行，同时使用手指刺血样本进行常规HIV检测。参考检测是血浆样本中的HIV病毒载量（VL），在中心实验室的Xpert平台上进行。AHI定义为按照国家串行RDT算法HIV检测结果为阴性或不一致，且HIV VL≥10,000 copies/ml，或在检测下限（40 copies/ml）至10,000 copies/ml之间连续两次检测HIV VL。确定HIV感染定义为连续RDT检测阳性，总体HIV感染定义为确定HIV感染或AHI。结果1363名受试者具有全部检测结果；49例（4.2%）被诊断为HIV（39例根据串行RDT算法确诊为HIV， 10例为AHI）。HIV阴性或常规RDT结果不一致的参与者中AHI患病率为0.9%（10/1124）。decide™HIV Early Detect检测总体HIV感染的敏感性为83.7% (95% CI 70.3 ~ 92.7)，检测AHI的敏感性为20% (95% CI 2.5 ~ 55.6%)；特异性同样高，为99.8% （95% CI 99.4-100）。结论：在我们的研究中，在护理点使用手指刺血样本进行的det™HIV早期检测检测AHI的灵敏度较低，与其他已发表的实验室环境评估形成对比，突出了对常用诊断测试进行现场评估的重要性。
Low sensitivity of the fourth-generation antigen/antibody HIV rapid diagnostic test Determine™ HIV Early Detect for detection of acute HIV infection at the point of care in rural Eswatini: a diagnostic accuracy study
Introduction
The diagnosis of acute HIV infection (AHI) is challenging in routine settings because it cannot be detected by routine third-generation antibody rapid diagnostic tests (RDTs). The current fourth-generation antibody/antigen RDT, Determine™ HIV Early Detect, has demonstrated high sensitivity in laboratory studies, but field evaluations at the point of care are lacking. We nested a diagnostic accuracy study within a larger study of the burden of sexually transmitted infections in rural Eswatini.
Methods
Adults were enrolled at six routine HIV testing sites (HTS) in the Shiselweni region between June 2022 and April 2023. Determine™ HIV Early Detect was performed by HTS counsellors in parallel with routine HIV testing using a finger-prick blood sample. The reference test was HIV viral load (VL) in the plasma sample, performed on the Xpert platform in the central laboratory. AHI was defined as a negative or discordant HIV test result according to the national serial RDT algorithm and an HIV VL >10,000 copies/ml, or two consecutive HIV VL measurements between the lower limit of detection (40 copies/ml) and 10,000 copies/ml. Established HIV infection was defined as a positive serial RDT test, and overall HIV infection as either established HIV infection or AHI.
Results
One thousand one hundred and sixty-three participants had all test results available; 49 (4.2%) were diagnosed with HIV (39 with established HIV according to the serial RDT algorithm and 10 with AHI). AHI prevalence among participants with HIV negative or discordant routine RDT results was 0.9% (10/1124). The sensitivity of Determine™ HIV Early Detect to detect overall HIV infection was 83.7% (95% CI 70.3–92.7) and to detect AHI was 20% (95% CI 2.5–55.6%); the specificity was equally high for both 99.8% (95% CI 99.4–100).
Conclusions
The low sensitivity of Determine™ HIV Early Detect to detect AHI when performed at the point of care using finger-prick blood samples in our study contrasts with other published evaluations from laboratory settings and highlights the importance of field evaluations of the commonly used diagnostic tests.
期刊介绍：
The Journal of the International AIDS Society (JIAS) is a peer-reviewed and Open Access journal for the generation and dissemination of evidence from a wide range of disciplines: basic and biomedical sciences; behavioural sciences; epidemiology; clinical sciences; health economics and health policy; operations research and implementation sciences; and social sciences and humanities. Submission of HIV research carried out in low- and middle-income countries is strongly encouraged.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
