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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 鈥 taking the question out of the results and the interpretation out of your hands. Just apply the patient鈥檚 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

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Features & Benefits

Eliminates error sources

  • Accurately times the test for you鈥攏o 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鈥攁dd sample and the analyzer does the rest.
  • Results in 5 minutes or less鈥攏o waiting for lab results.
  • Optional bar-code scanner saves time, simplifies data entry, and eliminates transcription errors.

Provides fail-safe measures

  • Proprietary Auto-Checks庐 technology on Multistix庐 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 鈥渋ndeterminate鈥 range where confirmatory testing is important
  • for interpreting the significance of low-level hCG in qualitative tests.
  • Operator lockout鈥攑revents 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鈥攅ach 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掳 to 30掳C (36掳 to 86掳F)

Sample Size

200 渭L 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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