The AcroMetrix® MRSA Positive Control is intended for use in assessing the performance of nucleic acid test procedures for the determination of the presence of MRSA 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® MRSA Positive Control has been formulated to mimic naturally occurring human specimens containing MRSA. Additionally, the intact bacteria format of the AcroMetrix® MRSA 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 MRSA DNA in human specimens. Because the AcroMetrix® MRSA Positive Control contains intact bacteria, the test methodology must include an extraction step that releases the bacterial DNA for amplification and detection, as appropriate to the test.
The AcroMetrix® MRSA 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.