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The AcroMetrix®HPV-16 Genotype Control is intended for use in assessing the performance of nucleic acid test procedures for the quantitative and qualitative determination of human papillomavirus DNA (HPV DNA). Routine use of external run controls enables laboratories to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and can assist in identifying increases in random or systematic error. For Research Use Only. Not for use in diagnostic procedures. The AcroMetrix®HPV-16 Genotype Control is compatible with samples that are obtained through Pap smears or biopsies and are preserved in Cytyc ThinPrep® Pap Test™ PreservCyt® Solution. AcroMetrix®HPV-16 Genotype Control is also suitable for use with specimens obtained by various procedures and stored in similar preservatives such as the Cervical Sampler™.
The AcroMetrix®HPV-16 Genotype Control is designed to help ensure the quality of nucleic acid test results and to monitor assay performance. Frequent testing of independent quality control samples provides a means of monitoring the performance of assays. Routine use of this control enables monitoring of day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and can assist in identifying increases in random or systematic error. The AcroMetrix®HPV-16 Genotype Control is designed to produce reactive (above the cutoff) results in Hybrid Capture® 2 (HC2) High-Risk HPV DNA test. It may also be suitable for other assays designed to detect HPV DNA in samples preserved in PreservCyt® solution. The control is for research use only and DOES NOT HAVE ASSIGNED VALUES.
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