What does Clinitek status mean?

What does Clinitek status mean?

The CLINITEK Status®+ Analyzer is an automated point-of-care urinalysis analyzer that aids in the assessment, diagnosis, and monitoring of chronic conditions. It is the only dual-purpose point-of-care analyzer for urinalysis testing and urine hCG pregnancy testing.

Is the Clinitek status waived?

The new CLINITEK Status+ Analyzer features new automatic checks (Auto-Checks). The analyzer automatically checks each test strip for humidity exposure and identifies Siemens test strips. Expand your options, with the broadest urine analyzer test menu! FDA-Cleared/CLIA Waived.

What is the test principle of Clinitek Status Analyzer?

The CLINITEK Status Connect System performs a “self-test” and calibration each time you power on the system. The analyzer performs an automatic calibration each time you run a test. The white calibration bar (on the test table) provides NIST traceable calibration.

How do you read hCG Clinitest?

The CLINITEST hCG test

  1. When the urine hCG level is ≥ 25 mIU/mL, it indicates a positive result.
  2. When the urine hCG level is ≤ 5 mIU/mL, it indicates a negative result.
  3. When the urine hCG level is between 5 and 25 mIU/mL, it indicates a borderline result.

How long are the Clinitek Reagent Strips stable once opened?

Record “Open Date” and “Expiration Date” on each QC vial once opened. Bring to room temp before use. Do not use beyond manufacturer’s expiration date or more than 30 days after opening. Record “Open Date” on each box once opened.

Which color of urine may indicate jaundice or hepatitis?

Dark brown but clear urine is a sign of a liver disorder such as acute viral hepatitis or cirrhosis, which causes excess bilirubin in the urine. It can also indicate severe dehydration or a condition involving the breakdown of muscle tissue known as rhabdomyolysis.

What is the first step for a CLIA waived test?

You can enroll your laboratory or testing site in the CLIA program by completing an application (Form CMS-116 ) available on the CMS CLIA website or from your local State Agency . Send your completed application to the address of the local State Agency for the State in which your laboratory or testing site is located.

How do I read my hCG Clinitest pregnancy test?

What does the R on Clinitest hCG mean?

The Clinitest hCG Pregnancy Test is a chromatographic immunoassay (CIA) for the rapid determination of hCG in urine. A pink-colored line at the reference region (R), the area between the control line region and the test line region, has been adjusted to a level approximating 25 mlU/mL hCG.

What does the R mean on Clinitest hCG?

What is Clinitest hCG?

The CLINITEST® hCG test is a qualitative, instrument-read, urine test for early detection of pregnancy. The test is performed on the CLINITEK Status® family of analyzers, provides results in as little as 2 minutes, and is CLIA-waived on the CLINITEK Status family of analyzers.