CLINITEST® hCG Pregnancy Test

Pregnancy testing has become more convenient and reliable with the introduction of the CLINITEST® hCG test for use with the CLINITEK Status® family of analyzers.

The CLINITEST hCG pregnancy test provides users with quick, simple instrument-read-and-reported test findings, eliminating any uncertainty regarding the results and removing the burden of interpretation. Users only need to apply the patient’s sample; the CLINITEK Status®+ Analyzer will take care of the rest.

  • Qualitative, instrument-read test for early detection of pregnancy
  • For use on the CLINITEK Status family of analyzers
  • Offers a flag for findings that are “indeterminate,” indicating that confirmatory testing is necessary to determine the relevance of low levels of hCG in qualitative tests

Features and benefits

  • Users can report findings with confidence using the CLINITEK Status® series of analyzers and the CLINITEST® hCG pregnancy test
  • Fast, accurate instrument-read results eliminate interpretation and offer precise results for the patient
  • The CLINITEK Status+ Analyzer accurately times the reading of results, eliminating hands-on waiting time
  • Results are printed out, which reduces transcribing mistakes and saves time:
    • Less opportunity for error
    • CLIA-waived
    • Ideal for busy point-of-care testing sites
    • Reduced user involvement and time
    • More objective results
    • Increased time for patient care
    • Consistent reliable results, every time
    • Enhanced uniform test method
    • Decreased user uncertainty

Assays

  • Test available:
    • Human chorionic gonadotropin (hCG) is used to detect pregnancies

Technical specifications

Source: Siemens Healthineers

. .
Quality Control Two procedural controls
Storage Refrigerated or at room temperature,
2° to 30 °C (36° to 86 °F)
Sample Size 200 μL urine for a single test
Time to Result 5 minutes or less to confirm result
Method Lateral flow, chromatographic result
Clinical Accuracy >99%
Sensitivity Equal or greater than 25 mIU/mL

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