CLINITEST hCG Pregnancy TestStop reading between the lines and start using CLINITEST hCG - CLIA-waived

CLINITEST® hCG Pregnancy Test
CLINITEST hCG Pregnancy Test

Fast, reliable hCG testing with no babysitting.

Pregnancy testing became simpler and more reliable with the CLINITEST® hCG test for use with the CLINITEK Status® family of analyzers.

The CLINITEST hCG pregnancy test gives you fast, easy instrument-read-and-reported test results — taking the question out of the results and the interpretation out of your hands. Just apply the patient’s sample and let your CLINITEK Status®+ Analyzer do the rest.

  • Qualitative, instrument-read test for early detection of pregnancy
  • For use on the CLINITEK Status family of analyzers
  • Provides a flag for results in the "indeterminate" range where confirmatory testing is important for interpreting significance of low level hCG in qualitative tests

Download the CLINITEST hCG Sell Sheet.

Features & Benefits

Eliminates error sources

  • Accurately times the test for you—no watching the clock!
  • Automates and removes subjectivity of result interpretation.
  • Automatically transmits test results to minimize transcription errors.

Improves workflow efficiency

  • Frees staff for patient care with true walkaway operation—add sample and the analyzer does the rest.
  • Results in 5 minutes or less—no waiting for lab results.
  • Optional bar-code scanner saves time, simplifies data entry, and eliminates transcription errors.

Provides fail-safe measures

  • Proprietary Auto-Checks® technology on Multistix® Reagent Strips prevents testing if expired materials are used or quality-control testing fails or is not performed.
  • Provides a unique flag for results in the “indeterminate” range where confirmatory testing is important
  • for interpreting the significance of low-level hCG in qualitative tests.
  • Operator lockout—prevents use by unauthorized users.

Improves data capture and traceability

  • Device connectivity provides:
    • 100% data capture
    • Automatic result recording and transmission to EMR/EHR or LIS/HIS
  • Audit-ready—each test result is linked to patient ID, operator ID, material lot number, and expiration date.

Assays

Test available:
hCG (human chorionic gonadotropin) to detect pregnancy

Technical Specifications

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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