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The AcroMetrix® GBS Positive Control is intended for use in assessing the performance of nucleic acid test procedures for the determination of the presence of GBS 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. This product is for in-vitro diagnostic use. The AcroMetrix® GBS Positive Control has been formulated to mimic naturally occurring human specimens containing GBS. Additionally, the intact bacteria format of the AcroMetrix® GBS Positive Control allows for the verification of effective bacterial DNA extraction and purification. The controls are designed to monitor all procedural steps in test procedures for determining the presence of GBS DNA in human specimens. The AcroMetrix® GBS Positive Control contains intact bacteria, and the test methodology must include an extraction step that releases the bacterial DNA for amplification and detection, as appropriate to the test. The AcroMetrix® GBS Positive Control contains inactivated GBS. The AcroMetrix® GBS Positive 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 the analyst with a means of monitoring the performance of laboratory assays. Routine use of these 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. Expected results utilizing the AcroMetrix® GBS Positive Control must be established by the end user for their particular GBS DNA assay.
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