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Hepatitis C, RNA, Quantitative, PCR

Test code(s) 35645

Question 1. Why are HCV results being reported in IU/mL? What is log IU/mL?

IU/mL is the abbreviation for international units per milliliter. Results are reported in IU/mL units to facilitate comparisons between results generated by available test methods. This is important because the various methods are not standardized. Use of IU/mL helps standardize viral load test results.

We also report the viral load in log IU/mL units. PCR test results on the same sample can vary as much as 0.5 log IU/mL; thus, only changes greater than 0.5 log IU/mL are clinically significant. Reporting the viral load in log IU/mL units helps the doctor accurately interpret changes in viral load and better assess a patient's response to treatment.

Question 2. What do these test results mean: “<15 Detected” or “<15 Not Detected”?

A “<15 Detected” means the assay was able to detect HCV RNA but was not able to accurately quantitate the viral load. A “<15 Not Detected” means the assay did not detect HCV RNA (Target Not Detected).This test is performed using the COBAS® AmpliPrep/COBAS® Taqman® HCV Test v2.0. The lowest viral load this assay can accurately quantify is 15 IU/mL, but the limit of detection is 10-13 IU/mL. Therefore, we can qualitatively report detection even if the viral load is under 15 IU/mL.

This FAQ is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.
Document FAQS.22 Version: 2
 
Version 2 effective 11/12/2014 to present