Description
Unit: 1 Box
Regulatory Status: CLIA Waived
Contents: POS/NEG serum controls
Storage Requirements: Test kit 60° – 86° F, buffer solution 36° – 46° F
If you are testing under CLIA-waived status, the manufacturer recommends running controls:
• Each new lot
• Each new shipment (even if from the same lot previously received)
• Each new operator
• Monthly, as a continued check on storage conditions
• Whenever problems (storage, operator or other) are identified
• Other times as required by your laboratory’s standard QC procedures.
The positive and negative controls should be run according to laboratory requirements. These
controls should be run like an unknown sample. If the controls do not give expected results (positive
or negative), patient results must not be reported, and the testing should be re-run.
The Accutest TSH contains built-in quality control features. A pink line in the Control Zone should always be seen. It shows: (1) that enough volume is added and (2) that proper flow is obtained. If this line is missing, the test was not run correctly or it failed to function correctly. The test is invalid, and testing should be repeated using a new cassette.
The Accutest TSH whole blood, rapid TSH assay is a visual, non-instrumented, qualitative, solid-phase,
lateral flow, two-site immunochromatographic assay for identifying capillary or venous blood samples that contain TSH>5 microIU/mL. The test is intended for use as an in-vitro diagnostic device by medical professionals to screen for primary hypothyroidism. It is not intended for use as a screening method for neonatal hypothyroidism.
