Three-minute HIV test wins approval in China and the USA

China and the United States have both approved a rapid, portable HIV testing kit that is cheap to produce, easy to use and gives results in three minutes. It is being compared to home pregnancy tests and could revolutionise HIV testing.

After receiving distribution approval from China’s State Drug Administration in February, a small Canadian biotech company is rushing to produce 400,000 rapid HIV tests for the nation. “The Chinese government has finally acknowledged this is a problem. Now they’re trying to make prevention a priority,” said Daniel Sham of the company MedMira. The US Food and Drug Administration approved the test in April.

The test, which costs about US$2.25 to manufacture, detects antibodies in the blood and shows two red lines for a positive result. Unlike conventional HIV tests, MedMira’s test produces results in about three minutes. The Chinese order is for 400,000 tests to be distributed to clinics and hospitals.

The company said in a statement: “With the FDA approval, MedMira can market the Reveal Rapid HIV-1 Antibody Test for the detection of HIV-1 antibodies in serum or plasma. This test has a one-year shelf life at room temperature, the longest of any rapid HIV tests available in the United States. MedMira’s test also produces highly accurate results substantially faster than any other FDA-approved HIV diagnostic test.”

Stephen Sham, Chairman and CEO of MedMira, said: “We are very pleased to enter the United States market with the best rapid HIV test to date. Many countries view the approval to market of a diagnostic test by the FDA to be the gold standard of endorsement. Now that we have obtained this approval, we are very optimistic about the immediate expansion of MedMira’s operations. We look forward to fulfilling the global diagnostic marketplace with our unique diagnostic products.”

Sham called the earlier approval by China a landmark event for his company, which was founded in a university basement a few years ago. “This regulatory approval achieves one of the company’s strategic goals of gaining access to large markets where the power of our technology can be used to make a difference in a significant public health campaign,” he said.

Chinese HIV infection rates have surged, particularly in remote regions where IV drug use, prostitution, migration and blood transfusions have increased. In addition, China’s blood supply was largely unregulated in the 1980s and many private agencies mixed supplies, reused needles and operated without sterilised equipment.

MedMira – which also manufactures diagnostic tests to detect hepatitis – signed a deal recently to supply 1 million tests to the Democratic Republic of Congo. Health Canada approved the test in 1998.