由中國疾病控制中心（北京）進行的臨床試驗已經(jīng)證實了由Calypte生物醫(yī)學集團研制的5種艾滋病毒檢測方法的性能。

血液快速檢測方法的敏感性為100％，特異性為99.3％，精確性為99.4％；口腔唾液快速檢測方法敏感性為100％，特異性為99.8%，精確性為99.9％；尿液快速檢測的敏感性為97.2％，特異性為100％，精確性為99.5％。

血清和尿液艾滋病毒W(wǎng)estern印跡檢測方法同樣表現(xiàn)良好，根據(jù)Calypte公司的報道，敏感性分別為100%和98.4％。在中國不同省份和人群中評估了這些檢測方法的表現(xiàn)。這項臨床試驗包括了1506例受試者，其中247例已經(jīng)感染，1259例尚未感染。

Calypte公司總裁和首席執(zhí)行官Richard George博士指出：“在中國進行的臨床試驗的良好結(jié)果使我們備受鼓舞。中國疾病控制中心進行這些臨床試驗并提供試驗報告，他們的所作所為讓人肅然起敬。”George博士指出，已經(jīng)記錄存檔并加快審查進度進度的第一項應用是Aware HIV-1/2 OMT檢測，然后不久是Aware HIV-1/2尿液檢測。
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.