Coincidence of references
By using the China national reference for L1 genotyping of Human Papillomavirus genome to evaluate this kit, the results were consistent with both positive references and negative references. For enterprise references, the coincidence rates of 20 negative references and 18 positive references are both 100%.
The limit of detection (LoD)
The limit of detection for both HPV 16 and HPV18 are 500 copies/mL-1, and the limit of detection for other HPV types is 1×103 copies/mL-1.
Precision
The coefficient of variation of Ct values of precision references is not higher than 5% within-batch and inter-batch.
Interfering substances
10% white blood cells, 5% lubricant, 2% antibacterial lotion, 2mg/mL-1 hemoglobin, 0.1mg/mL-1 of mucin, 10 mg/mL-1 benzene ether embolism or 4mg/mL-1 nitric acid contained in the sample had no significant influence on the performance of the kit. However, still try to avoid any interference substances in the process of sampling.