Diagnostic test maker receives report on HIV tests from China clinical trials
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Calypte Biomedical Corp. (HIV) announced that it has received the final clinical trial report from the Chinese Centers for Disease Control (Chinese CDC) confirming the performance of the five Calypte HIV tests that were evaluated earlier this year.
Three rapid HIV tests, Aware HIV-1/2 BSP, Aware HIV-1/2 OMT, and Aware HIV-1/2 U were evaluated in these studies. These tests employ, respectively, blood, oral fluid, and urine samples. In addition, the Calypte HIV-1 Serum Western blot and the HIV-1 Urine Western blot tests were evaluated for their performance in various Chinese provinces and populations. The clinical trial was performed by the Chinese CDC.
The clinical trial of the three rapid tests included 1506 subjects; 247 of whom were infected and 1259 of whom were uninfected.
The serum and the urine HIV-1 Western blots also performed well, with sensitivities of 100% and 98.4%, respectively. The specificity of the urine Western blot was 100% and the specificity of the serum Western blot was 99.4%. The specificity of the serum Western blot was less than 100% as a result of two HIV-negative subjects whose sera displayed bands for p24, resulting in a so-called “indeterminate” interpretation. The presence of p24 antibodies is a common occurrence in uninfected individuals, and indeterminate results should not be confused with false positive results.
Richard George, president and CEO of Calypte said, “We are extremely encouraged by the excellent outcome of the China clinical trial. The Chinese CDC did an admirable job of conducting these studies and preparing the report. We now believe that all three rapid assays are approvable and that the OMT and urine tests are eligible for accelerated review.
“As I stated in our most recent conference call on August 15, the first application we file will be for approval of the Aware HIV-1/2 OMT test. We expect to make the submission in the coming weeks. The OMT application will be followed shortly by a submission for the Aware HIV-1/2 Urine test,” said George.
George continued; “Work in China continues at a vigorous pace to prepare for the impending launch of our sales effort after receipt of SFDA approval. Ron Mink, Calypte’s Chief Science Officer, and members of his scientific staff are currently at our manufacturing facility near Beijing training our staff to make the rapid assays. We are also expecting delivery and installation of automated manufacturing equipment in early September. It is very gratifying to see all of our hard work resulting in a successful conclusion.”
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