The Quality Analysis of National Supervising Sampling for Rubella Virus IgM Diagnostic Kits in 2014 / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the quality status of rubella virus IgM diagnostic kits by national supervising sampling.</p><p><b>METHODS</b>Using legal inspection combining with exploratory study, the positive and negative coincidence rate, detection limit and repeatability of kits were verified.</p><p><b>RESULTS</b>The results showed that 15 of 16 batches of kits were qualified using legal inspection, and the passing rate was 93.8%. The unqualified item was negative coincidence rate. In exploratory study, only 11 batches (68.8%) complied with industry standard. The unqualified items were negative coincidence rate, detection limit and repeatability.</p><p><b>CONCLUSION</b>At present, rubella virus IgM diagnostic Kits have some quality problems in the market. It is recommended that we adopt industry standard and national reference panel in the registration inspection for the future, which will prompt enterprises to improve quality.</p>