Clearview® COMPLETE HIV 1/2

Posted by admin on May 14th, 2014

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

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Product exclusively available for export to select markets.

SKU: 92111.0 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 closed system test with minimal sample volume requirement of 2.5 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

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

Specifications

  • Order No: 92111
  • Kit Qty: 25 Tests
  • CPT Code:  86703
  • CLIA Status2: Waived for Whole Blood
  • Non-Waived for Serum / Plasma
  • Accessories: HIV 1 / 2 Controls
  • Order No:  92112

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