Calypte公司艾滋病毒检测方法的临床试验结果令人鼓舞

 
由中国疾病控制中心（北京）进行的临床试验已经证实了由Calypte生物医学集团研制的5种艾滋病毒检测方法的性能。

血液快速检测方法的敏感性为100％，特异性为99.3％，精确性为99.4％；口腔唾液快速检测方法敏感性为100％，特异性为99.8%，精确性为99.9％；尿液快速检测的敏感性为97.2％，特异性为100％，精确性为99.5％。

血清和尿液艾滋病毒Western印迹检测方法同样表现良好，根据Calypte公司的报道，敏感性分别为100%和98.4％。在中国不同省份和人群中评估了这些检测方法的表现。这项临床试验包括了1506例受试者，其中247例已经感染，1259例尚未感染。

Calypte公司总裁和首席执行官Richard George博士指出：“在中国进行的临床试验的良好结果使我们备受鼓舞。中国疾病控制中心进行这些临床试验并提供试验报告，他们的所作所为让人肃然起敬。”George博士指出，已经记录存档并加快审查进度进度的第一项应用是Aware HIV-1/2 OMT检测，然后不久是Aware HIV-1/2尿液检测。
Results of HIV Test Trials
 
Clinical trials conducted by the Chinese Centers for Disease Control (Beijing) have confirmed the performance of five HIV tests developed by Calypte Biomedical Corp. (Lake Oswego, OR, USA).

A rapid test for use with blood (BSP) showed 100% sensitivity, 99.3% specificity, and 99.4% accuracy; a rapid test for use with oral fluid (OMT) showed 100% sensitivity, 99.8% specificity, and 99.9% accuracy; and a rapid test for use with a urine sample (U) showed 97.2% sensitivity, 100% specificity, and 99.5% accuracy.

The serum and the urine HIV Western blot tests also performed well, reports Calypte, showing sensitivity of 100% and 98.4%, respectively. The tests were evaluated on their performance in various Chinese provinces and populations. The trial involved 1,506 subjects, 247 of whom were infected and 1,259 who were uninfected.

“We are extremely encouraged by the excellent outcome of the China clinical trial,” stated Dr. Richard George, president and CEO of Calypte. “The Chinese CDC did an admirable job of conducting these studies and preparing the report.” Dr. George noted that the first application to be filed for accelerated review will be for the Aware HIV-1/2 OMT test, to be followed soon by the Aware HIV-1/2 urine test.