Shafran Stephen D, Conway Brian, Prasad Errol, Greer Jane, Vincelette Jean, Ellis C Edward, Haase David A, Walmsley Sharon L, Lalonde Richard G, Cameron D William
Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2B7.
Clin Infect Dis. 2002 Mar 1;34(5):658-61. doi: 10.1086/338812. Epub 2002 Jan 25.
The Merlin Immediate HIV-1 and -2 Test (Merlin point-of-care [POC] test; Merlin Biomedical & Pharmaceutical) is a nitrocellulose membrane flow immunoassay performed at the POC with the use of blood obtained from a fingerprick. The results of this test were compared with those of enzyme immunoassay (EIA) performed on venous blood samples in the laboratory. Positive results of both tests were confirmed by a Western blot (WB). The study included 553 adults with known HIV (human immunodeficiency virus) seropositivity (all of whom had positive Merlin POC test results) and 2659 adults with unknown HIV serostatus (20 of whom had positive EIA/WB results; 19 of the 20 also had positive Merlin-POC test results). The sensitivity of the Merlin POC test was 95.0% for patients with an unknown HIV serostatus and 99.83% for those with a positive serostatus. For previously untested subjects, the test's specificity and positive predictive value were 100%, its negative predictive value was 99.96%, and its overall accuracy was 99.96%. The Merlin POC test is highly accurate for the detection of HIV antibodies.
梅林即时HIV-1和-2检测（梅林即时检测[POC]；梅林生物医学与制药公司）是一种硝酸纤维素膜流动免疫测定法，在即时检测点使用手指采血进行检测。该检测结果与实验室对静脉血样本进行的酶免疫测定（EIA）结果进行了比较。两种检测的阳性结果均通过蛋白质印迹法（WB）进行确认。该研究纳入了553名已知HIV（人类免疫缺陷病毒）血清学阳性的成年人（他们的梅林即时检测结果均为阳性）以及2659名HIV血清学状态未知的成年人（其中20人EIA/WB结果为阳性；这20人中19人的梅林即时检测结果也为阳性）。对于HIV血清学状态未知的患者，梅林即时检测的灵敏度为95.0%，对于血清学阳性患者为99.83%。对于之前未检测的受试者，该检测的特异性和阳性预测值为100%，阴性预测值为99.96%，总体准确率为99.96%。梅林即时检测在检测HIV抗体方面具有高度准确性。
