Florida Bureau of Public Health laboratories
Hepatitis C Virus, RNA NAAT
The hepatitis C virus, RNA NAAT test provides results for hepatitis C utilizing a real-time transcription-mediated amplification (TMA) testing method.
Analyte(s)
Hepatitis C RNA
Test Code
0390
Testing Location
Testing Department
Serology
Pre-approval Required?
None
Required Forms
BPHL Test Requisition, DH1847
(not needed if orders are placed via electronic order)
Supply Ordering
Supplies may be requested from your servicing laboratory. Supplies ordered from BPHL should only be used for specimen sent to the BPHL for testing.
Turn Around time
7 business days after receipt at the laboratory.
Minimum Volume
At least 2 mL serum
Collection Media
“Tiger” or “yellow” top SST tube
Specimen Sources
Serum
Specimen Labeling
Specimen must be labeled with at least two unique patient identifiers, e.g., name and DOB, and the date of collection.
Information on the specimen must match the requisition and/or test order.
Special SPecimen Preparation
Centrifuge the SST within 8 hours of collection.
Storage Conditions
Specimens may be stored for up to 5 days after collection at 2-8° C.
If testing will be delayed more than 5 days after collection, remove serum from the clot, red blood cells, or separator gel and store at -20° C or colder. Avoid more than 3 freeze/thaw cycles.
Packaging and Shipping
Ship in a cooler with ice packs at 2-8° C to be received at the laboratory no more than 5 days from the collection date.
Specimens stored frozen should be shipped frozen to avoid additional freeze/thaw cycles.
unsatisfactory specimen
1) Incorrect source or incorrect collection device was used
2) Specimen was not labeled with 2 unique patient identifiers
3) Information on specimen does not match requisition/test order
4) Grossly hemolyzed
5) Leaked in transit
7) No specimen received with test order
9) Specimen not centrifuged
10) Quantity not sufficient (QNS)
11) Specimens that exceed the storage limitations listed above.
12) Specimens received at 2-8°C and greater than 5 days after collection will be cancelled.
Interferences and Limitations
1) Avoid cross-contamination during sample handling steps.
2) Low volume specimens that are diluted with sample diluent (in order to reach minimum test volume) can be tested using the 1:3 option. A diagnostic interpretation should not be made from a “Not Detected” result for serum or plasma specimens that have been diluted. Obtain a new, undiluted specimen and retest.
3) Though rare, mutations within the highly conserved regions of the viral genome covered by the primers and/or probes in the Aptima HCV Quant Dx assay may result in failure to detect the virus.
Reference Range
Not detected
Result Indicator
Qualitative: Positive or Negative.
Viral load: If positive, reported in Log10 IU/mL and IU/mL. If negative, reported as Not Detected.
Invalid result: if error in generation of the result. Submit new specimen and order Test 0390.
Reference lab
None
Reflex testing
None
Additional Information
For Test 0380 Hepatitis Chronic Panel, HCVAb reactive results are automatically reflexed to HCV RNA NAAT.
May also be ordered as a stand-alone test, for example to confirm a rapid test result.
HCV RNA Concentration: Negative
Log10 Not Detected
IU/mL Not Detected
HCV RNA not detected by Rt-TMA (NAAT).
RNA Concentration: Positive
Log10 <1.00
IU/mL <10
HCV RNA detected by Rt-TMA (NAAT), below the lower limit of quantification (LLoQ) of the assay. HCV RNA concentration less than 10 IU/mL (<1.00 Log10 IU/mL).
RNA Concentration: Positive
Log 10 (1.00 – 1.40)
IU/mL (10 – 25)
HCV RNA detected and quantified by Rt-TMA (NAAT). HCV RNA concentration is within the linear range of 10 to 25 IU/mL (1.00 to 1.40 Log10 IU/mL).
RNA Concentration: Positive
Log10 (1.40 – 8.00)
IU/mL (25 – 100,000,000)
HCV RNA detected and quantified by Rt-TMA (NAAT). HCV RNA concentration is within the linear range of 25 to 100,000,000 IU/mL (1.40 to 8.00 Log10 IU/mL). Current HCV infection.
RNA Concentration: Positive
Log10 (>8.00)
IU/mL (>100,000,000)
HCV RNA is detected above the upper limit of quantification (uLoQ). Current HCV infection.
RNA Concentration: Invalid
Specimen should be recollected and order Test 0390