Pregnancy (hCG) Serum/Urine

Product catalog summary

Overview: The document provides detailed information on SAS™ qualitative rapid immunoassay tests for detecting Human Chorionic Gonadotropin (hCG) in serum or urine, primarily used for early pregnancy testing. These tests utilize colloidal gold technology and are designed for quick and reliable results.

Product Descriptions:

SAS™ One-Step Pregnancy: Detects hCG in urine with a sensitivity of 25 mIU/mL and specificity over 99%. Results are available within 4 minutes. The test is CLIA waived and has a shelf life of 24 months.
SAS™ Serum/Urine hCG: Suitable for both serum and urine, with a sensitivity of 25 mIU/mL and specificity over 99%. Results are available in 4 minutes. The test is CLIA waived for urine and non-waived for serum, with a shelf life of 21 months.
SAS™ Ultra hCG Serum/Urine: Offers higher sensitivity with 10 mIU/mL for serum and 20 mIU/mL for urine. Results are available in 5-8 minutes for serum and 4 minutes for urine. The test is CLIA waived for urine and non-waived for serum, with a shelf life of 18 months.
SAS™ Pregnancy Strip: Detects hCG in urine with a sensitivity of 25 mIU/mL and specificity over 99%. Results are available within 4 minutes. The test is CLIA waived and has a shelf life of 24 months.

Test Procedure:

For the SAS™ One-Step Pregnancy and SAS™ Serum/Urine hCG tests, dispense 3 to 4 drops of specimen into the sample well and read results after 4 minutes.
For the SAS™ Ultra hCG Serum/Urine test, read serum results after 5-8 minutes and urine results after 4 minutes.
For the SAS™ Pregnancy Strip, dip the strip into the urine specimen for at least 15 seconds and read results after 4 minutes.

Interpretation of Results:

A positive result is indicated by the appearance of two colored lines, one in the control area and one in the specimen area.
A negative result is indicated by a single colored line in the control area.

Additional Information: All tests are simple to run with built-in controls, require room temperature storage, and are listed in College of Pathologist (CAP) surveys and American Proficiency Institute (API).

Catalog excerpts

Early Pregnancy Testing Qualitative rapid immunoassay tests based on the SAS™ colloidal gold t echnology for the determination of H uman Chorionic onadotropin G (hCG) in serum or urine (a visual method) • SAS™ One-Step Pregnancy • SAS™ Serum/Urine hCG • SAS™ Ultra hCG Serum/Urine • SAS™ Pregnancy Strip Reliable Diagnostic Tests

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• CLIA Classification: Waived • Simple to run with built-in control • Results within 4 minutes • Room temperature storage • 24-month shelf life Description SAS™ One-Step Pregnancy Application/Shelf Life Sensitivity, Specificity Results/ Minutes Detects hCG in urine (Shelf Life: 24 mos.) 25 mIU, 250 mIU, Negative, 3 Vials/Pk (NOTE: For use with 087525, 087430, 087730, 087750, 087731, and 087751) CLIA WAIVE Urine D/ Only • CLIA Classification: Waived for urine and non-waived for serum tests • Simple to run with built-in control • Results within 4 minutes • Room temperature storage • 21-month shelf...

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Test Procedure Dropper The pouch must be at room temperature before opening to avoid condensation of moisture on the membrane. Allow specimen and/ or controls to reach room temperature prior to testing. 1. Remove the test device from the protective pouch and place it on a flat surface. Label the device with patient or control identifications. 2. Dispense 3 to 4 drops (approximately 0.15 mL) of specimen into the round sample well (see illustration). Wait for colored lines to appear. Minutes/ Urine Minutes/ Serum SAS™ One-Step Pregnancy and SAS™ Serum/Urine hCG— Read serum and urine results...

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• CLIA Classification: Waived • Simple to run with built-in quality control check • Results within 4 minutes or less • No pipetting or counting drops • Room temperature storage • 24-month shelf life Description SAS™ Pregnancy Strip Application/Shelf Life Sensitivity, Specificity Results/ Minutes Detects hCG in urine (Shelf Life: 24 mos.) 25 mIU, 250 mIU, Negative, 3 Vials/Pk (NOTE: For use with 087525, 087430, 087730, 087750, 087731, and 087751) Test Procedure 1. Dip test strip into the urine specimen. NOTE: Do not immerse the test strip beyond the “Stop Line.” 2. Leave the test strip immersed...

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