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The first FDA-approved, CLIA-waived rapid HCV test

The OraQuick® HCV test is FDA approved for detecting HCV antibodies in fingerstick and venipuncture whole blood. Our simple platform enables healthcare providers to deliver an accurate diagnosis in 20 minutes.

Accuracy

Clinically proven performance, OraQuick® HCV is greater than 98% accurate.

Appropriate For Testing in:

• Public Health Settings
• Physician's Offices
• Community-Health Clinics
• Laboratories
• Emergency Rooms

Key Product Features:

Rapid Results
• Point-of-care-testing results in 20 minutes

Laboratory Accuracy
• Greater than 98% accurate
• Tests for multiple HCV genotypes

Easy-to-Use
• Fingerstick and Venipuncture whole blood collection
• CLIA-waived

European Kit Configurations

The only CE-marked, point-of-care-device that works on oral fluid, whole blood, serum and plasma for HCV

The OraQuick® HCV Rapid Antibody Test enables healthcare providers to deliver an accurate diagnosis, leading to improved linkage-to-care. Our simple two-step platform provides the most versatile testing platform for patient and provider.

Appropriate For Testing In:

OraQuick® is appropriate for testing in the following locations:
• Physician Health Settings
• Physician Offices
• Community Health Clinics
• Laboratories
• Emergency Rooms

Accuracy:

Clinically proven performance, OraQuick® HCV is greater than 99% accurate with whole blood, serum or plasma.
• Laboratories
• Emergency Rooms
• Public Health Facilities and Clinics
• Physicians Offices
• Accidental Exposure Situations

Key Product Features:

• Oral Fluid, Fingerstick or Venipuncture Whole Blood, Serum or Plasma Sample Collection
• Easy-to-Use
• Greater than 99% Accurate*
• Test Results in 20 Minutes
• Tests for Multiple HCV Genotypes
• 18 Month Shelf-Life from date of Manufacture
• Portable

*Whole Blood, Plasma and Serum

Flexible Specimens for Clinical and Non-Clinical Settings

Oral Fluid
Step 1 -
Collect Specimen
Swab between the teeth and upper and lower gum once.
Step 2 -
Insert device into buffer
Step 3 -
Read between 20 and 40 minutes
Non-Reactive
Line in the C Zone

Reactive
Line in the C & T Zones
Fingerstick
Step 1 -
Collect Specimen & Mix in buffer
Step 2 -
Insert device into buffer
Step 3 -
Read between 20 and 40 minutes
Non-Reactive
Line in the C Zone

Reactive
Line in the C & T Zones
Venipuncture Whole Blood
Step 1 -
Collect Specimen & Mix in buffer
Step 2 -
Insert device into buffer
Step 3 -
Read between 20 and 40 minutes
Non-Reactive
Line in the C Zone

Reactive
Line in the C & T Zones
Serum/Plasma
Step 1 -
Collect Specimen & Mix in buffer
Step 2 -
Insert device into buffer
Step 3 -
Read between 20 and 40 minutes
Non-Reactive
Line in the C Zone

Reactive
Line in the C & T Zones

Training & Certification

Do you need training on this product? Take our training course.

*OraSure provides information regarding reimbursement (including, in some instances, potentially applicable CPT, HCPCS and/or analogous state or local codes or designations) for background purposes only. It does not constitute legal advice or a recommendation regarding clinical practice. Information provided is gathered from third-party sources and is subject to change without notice. The provider has the responsibility to determine medical necessity and to submit appropriate codes and charges for care provided. Any decision regarding specific coding is at the discretion of the healthcare professional, and provision of this information does not guarantee or facilitate reimbursement. OraSure makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other payers as to the correct form of billing or the amount that will be paid to providers of service. Please contact your Medicare contractor, insurance provider, other payers, reimbursement specialists and/or legal counsel for interpretation of coding, coverage and payment policies or specific billing questions or concerns. Nothing herein is intended to promote or facilitate the purchase or use of products outside of their approved or cleared indications, and appropriate use of products should be based on the healthcare professional’s medical judgment.

© OraSure Technologies Inc., 2024