Clearview® HIV 1/2 STAT-PAK®

Posted by admin on May 14th, 2014

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The Clearview® HIV 1/2 STAT-PAK® assay is a single use, immunochromatographic test used to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum and plasma specimens.

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Product exclusively available for export to select markets.

SKU: 92110.0 Category:

Description

Benefits

  • Rapid: Reactive results in 15 minutes allows for timely decision making while the patient is present
  • Flexible: Many different approved sample types including serum, plasma, fingerstick or venipuncture whole blood allows for testing in many different laboratory and practice settings. CLIA Waived for whole blood
  • Convenient: Easy to use test with minimal sample volume requirement of 5.0 µls is less invasive for patients and reduces biohazard exposure risks
  • Cost Effective: Long shelf life of 24 months from date of manufacture provides flexibility to purchase in volume for increased savings
  • Accurate: Greater than 99.7% sensitivity and 99.9% specificity.1

Specifications

  • Order No: 92110
  • Kit Qty: 20 Tests
  • CPT Code:  86703
  • CLIA Status2: Waived for Whole Blood
    • Non-Waived for Serum / Plasma
  • Accessories: HIV 1 / 2 Controls
    • Order No:  92112

References

1. Sensitivity is for HIV-1.  See package insert for complete performance detail

2. Any modification by the laboratory to the test system or FDA approved test system instructions will result in the test no longer meeting the requirement for waived category