Abbott high-risk human papillomavirus test kit - Taiwan Registration 6d59243050b34151fe87256d33d333a5

This product is a qualitative in vitro test method that uses the automated Alinity m system to detect the DNA of 14 strains of high-risk human papillomavirus (HR HPV) in clinical specimens, including HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. The test of this product can clearly identify HPV types 16, 18 and 45, and can simultaneously detect other high-risk genotypes (31/33/52/58) and (35/39/51/56/59/66/68) that reach the level of clinically relevant infection. This product is suitable for: screening patients with cervical cytology results of ASC-US (undefined atypical squamous epithelial cells) to determine whether colposcopy is required. This test result does not prevent a woman from having a follow-up colposcopy. Auxiliary screening for cervical cytology to assess the presence or absence of high-risk HPV. Used in first-line screening to identify high-risk groups of women who are prone to cervical cancer or have high-grade disease. To assess the presence or absence of HPV type 16 or 18 with or without cervical cytology to identify women at high risk of developing cervical cancer or with high degree of disease. The test results of this product should be evaluated by the physician in cytology, medical history, other risk factors and professional guidelines as a guide for patient management.

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