Abstract:

Microscopy of vaginal secretions is a routine item of obstetrics and gynecology. With the development of the automation of determination technology，the automatic vaginal secretion analysis systems based on different determination principles have been developed and applied to meet the needs of large clinical sample size，high efficiency and standardization. However，wet smear/Gram staining microscopy is still the gold standard for the diagnosis of common infectious diseases of female genital tract，which is a reference method for assessing the accuracy of automated instrument determination results. As the current quality documents still lack unified requirements and detailed guidance for the review rules of automatic vaginal secretion analysis in body fluid，the Laboratory Medicine Branch of Chinese Association of Geriatric Health Medicine Research and the Laboratory Medicine Committee of Shanghai Scientific Association of Better Birth and Better Upbringing（Shanghai Maternal and Child Health Association） jointly formulated the expert consensus on the establishment and validation of review rules for automatic vaginal secretion analysis system based on national standards，industry standards，quality system requirements and relevant domestic and foreign guidelines，relevant literature reports，which includes the establishment method，verification method and application of the review rules for automatic vaginal secretion analysis system，in order to standardize the establishment of the review rules for automatic vaginal secretion analysis system and ensure the accuracy of the determination results.

Key words: Vaginal secretion, Automatic determination, Microscopy, Review rule, Expert consensus