The human chorionic gonadotropin (hCG) hormone, which appears soon after conception, is an excellent and reliable marker for the early detection of pregnancy. The hCG pregnancy test is done to check for the hormone hCG in blood or urine. The test is used to see if a woman is pregnant and can be done as part of a screening test for birth defects. The sensitive CLINITEST hCG pregnancy test from Siemens provides fast and reliable instrument-read-and-reported test results.
The CLINITEST hCG pregnancy test employs an easy-to-use cassette that is utilized with the CLINITEK Status family of analyzers. CLINITEK Status analyzers:
- perform automatic quality checks for proper sample flow and adequate sample which helps improve QC
- create error flags when such conditions are not met, and
- confirm that the test has been properly completed
This CLIA-waived CLINITEST hCG pregnancy test indicates a positive result in two minutes and a negative result in five minutes. It eliminates hands-on waiting time, which improves workflow and increases the time for patient care.
Performing the test is simple. After mounting the cassette on a test table, the urine sample is added to the sample well. The cassette is then automatically drawn into the analyzer. The analyzer reports qualitative hCG results as negative (hCG level is ≤ 5 mIU/mL), positive (hCG level is ≥ 25 mIU/mL) or borderline (hCG level is between 5 and 25 mIU/mL). The CLINITEK Status+ Analyzer precisely times the reading of results, eliminating hands-on waiting time.
The CLINITEK Status Connect System allows the results to be automatically transmitted to a HIS or LIS for better data capture. Ideal for busy point-of-care testing sites, printed results eliminate transcription errors and save time.
A recent www.news-medical.net report discussed a validation study done in 2012 by the Siemens facility in Elkhart, Indiana to evaluate the performance of the CLINITEST hCG test on three lots of newly developed CLINITEST hCG pregnancy test cassettes over a period of two months. Up to 175 hCG positive and 500 hCG negative clinical urine samples were tested on three CLINITEK Status analyzers and six CLINITEK Status+ across the three lots. Testing was carried out in multiple runs, with both positive and negative samples tested in each run. The study found that:
- Of the 13,500 tests, only three reported a false-positive result with a negative sample indicating a ≤ 0.04% rate across the three CLINITEST hCG cassette test lots.
- The rate of agreement of positive results with positive samples was ≥ 99.9%, exceeding the performance acceptance criterion of ≥ 99.1%.
- All of the tests on all negative samples and all of the tests on all positive spiked samples reported negative and positive results, respectively.
With its fast, accurate and reliable results, the CLINITEST hCG test has become a dependable marker for early diagnosis of pregnancy. The results of the study support the growing uptake of this hCG test as an alternative means to conventional ‘dip and read' pregnancy test approaches.
However, confirmatory testing is important for interpreting the significance of low level hCG in qualitative tests. As with any kind of diagnostic test, a single CLINITEST hCG test result should not be used to make a clinical diagnosis. If negative test results are obtained in women suspected to be pregnant, a re-test should be performed on a urine sample acquired 48 to 72 hours later.