The product Bacterial Vaginosis Rapid Assaying Card (patent serial ZL200530060155.6) has got through the authentication by national center for clinical laboratory of MOH (the Ministry of Health). The clinical evaluation was conducted with 200 cases of suspicious vaginosis, age averaged 36.7, in Department of Gynecology of Beijing Hospital, which is directly administered by MOH. The diagnosis criteria strictly comply with Amsel standard, a well accepted classical norm guiding BV diagnosis. The BV card is used with classical Amsel diagnosis as control. The result shows that 53 cases are positive with BV card among which 43 cases are positive and 10 cases are negative with Amsel, and 147 are negative with BV card among which 4 are positive and 143 are negative with Amsel. The sensitivity is 91.49% and the specificity is 93.46%. The kit is characterized by simplicity, rapidity, sensitivity and point of care, needing no auxiliary instruments and is extensively applied in large scale rapid screening tests of bacterial vaginosis.
