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Novel, High-Sensitivity, Quantitative HCV Test


More than 170 million individuals are chronically infected with Hepatitis C Virus (HCV), and it is a major cause of hepatocellular carcinoma, liver cirrhosis, and liver-related mortality. A sensitive method to quantify HCV RNA is paramount to the management of patients undergoing antiviral therapy. A quantitative HCV viral load test, using novel probe technology, was developed by Enzo for use in the quantitative detection of HCV RNA. The AMPIPROBE® HCV Test is a realtime reverse transcription quantitative polymerase chain reaction test. It is intended for the quantitative detection of HCV RNA, genotypes 1 through 6, in serum.

Enzo Clinical Labs received
New York State Department of Health
approval for its AMPIPROBE® HCV
test for the quantitative detection
of Hepatitis C virus

AMPIPROBE® HCV offers 50% greater
sensitivity than leading commercially
available tests in the US

Enzo’s AMPIPROBE® HCV test is highly sensitive, detecting as little as 5.5 IU/mL in serum with a positive rate greater than 95%.* Additionally, the test uses substantially less sample input than leading tests currently offered in clinical laboratories.

Higher sensitivity AMPIPROBE®
HCV test is ideal for monitoring
viral load during anti-viral therapy.

The AMPIPROBE® HCV was tested side-by-side and exceeded the specifications of the current market leader

  • Higher-sensitivity allows you to
    detect more and quantity more
    than competitive tests

  • Smaller sample input allows
    remaining extracted samples to
    be used in other tests
Reported Sensitivity 10 IU/ml 15 IU/ml
Sample Volume 600 μL 650 μL
LOD* Serum 5.5 IU/ml 12 IU/ml
* Limit of Detection (LOD) by Probit at 95%


Center for Disease Control (CDC) Recommended Testing Sequence
For Identifying Current Hepatitis C Virus (HCV) Infection
CD Recommended Testing Sequence For Identifying Current Hepatitis C Virus (HCV) Infection
Source: CDC. Testing for HCV infection: An update on guidance for clinicians and laboratorians. MMWR 2013;62(18).

For additional information on HCV Screening:
  1. “Testing Recommendations for Hepatitis C Virus Infection.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 15 Oct. 2015. Web. 07 Mar. 2016.
  2. Chou, Roger, Erika Barth Cottrell, Ngoc Wasson, Basmah Rahman, and Jeanna-Marie Guise. “Screening for Hepatitis C Virus Infection in Adults: U.S. Preventive Services Task Force Recommendation Statement.” Annals of Internal Medicine Ann Intern Med 158.2 (2013): 101-08. Print.
Test Name: Hepatitis C Ab* Hepatitis C PCR Quant
Test Code: 8511 6385
Methodology: Electrochemiluminescence RT-PCR
Specimen Requirements: Serum samples Serum samples
* Per CDC Guidelines, all reactive HCV antibody screen tests may be reflexed to HCV Quant.
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