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FibroTest-ActiTest Panel

Item Value
Approval req'd? No
Available Stat? No
Test code HCVFT
Performed by Quest
Sendout? Yes
Method Nephelometry & Spectrophotometry
Patient Preparation Overnight fasting is preferred
Container type Gold top or Red top
Amount to Collect 7 mL blood
Sample type Serum
Preferred volume 3.5 mL serum
Min. Volume 2 mL serum
UCSF Rejection Criteria Patient < 2 years old, gross hemolysis or lipemia, QNS for one or more analysis
Processing notes Aliquot and freeze serum, ship frozen to China basin. Order Quest test code 92688.
Ref Lab Rejection Criteria Patient < 2 years old, gross hemolysis or lipemia, QNS for one or more analysis
Units See normal ranges
Normal range Alpha-2-Macroglobulin
Age Normal
< 18 years Not established
≥ 18 years 106-279 mg/dL

Age Normal range
< 18 years Not established
≥ 18 years 94-176 mg/dL

Apolipoprotein A1
Sex/age Normal range
< 18 years Not established
Male ≥ 18 years 94-176 mg/dL
Female ≥ 18 years 101-198 mg/dL

Total Bilirubin
Age Normal range
2-9 years 0.2-0.8 mg/dL
10-19 years 0.2-1.1 mg/dL
≥ 20 years 0.2-1.2 mg/dL

Gamma Glutamyl Transpeptidase (GGT)
Sex Age Normal range
Male 2-12 years 3-22 U/L
Male 13-15 years 8-32 U/L
Male 16-19 years 9-31 U/L
Male 20-29 years 3-70 U/L
Male 30-39 years 3-90 U/L
Male 40-54 years 3-95 U/L
Male 55-59 years 3-85 U/L
Male ≥ 60 years 3-65 U/L
Female 2-12 years 3-22 U/L
Female 13-15 years 7-18 U/L
Female 16-19 years 6-26 U/L
Female 20-29 years 3-40 U/L
Female 30-39 years 3-50 U/L
Female 40-49 years 3-55 U/L
Female 50-59 years 3-70 U/L
Female ≥ 60 years 3-65 U/L

Alanine Aminotransferase (ALT)
Age Male Female
2-3 years 5-30 U/L 5-30 U/L
4-12 years 8-30 U/L 8-24 U/L
13-15 years 7-32 U/L 6-19 U/L
16-19 years 8-46 U/L 5-32 U/L
≥ 20 years 9-46 U/L 6-29 U/L
Synonyms HCV Fibrosure; Cirrhosis; Hepatitis C; HCV; Hepatic fibrosis
Stability Room temperature 1 day, refrigerated 5 days, frozen at -20C 5 days, frozen at -70C 28 days
Turn around times 3-5 days
Additional information FibroTest and ActiTest permit the non-invasive evaluation of Hepatitis C (or B) individuals for the presence of liver fibrosis and liver inflammation, respectively. The FibroTest and ActiTest scores are calculated based on patient age, gender and concentrations of serum of y-glutamyl transferase (GGT), total bilirubin (TB), a-2 macroglobulin, haptoglobin, apolipoprotein A1 and alanine aminotransferase (ActiTest). Fibrotest and ActiTest Scores, on a scale of 0.0 to 1.0, are assigned a Metavir scale indicating the level of fibrosis or inflammation present.

The FibroTest uses the same methodology and algorithm as the FibroSure test previously sent to LabCorp.

In a comparison study, 80 samples, previously sent to LabCorp for analysis in their FibroSure assay, were used to calculate the scores through both the Quest Diagnostics server and via a secure interface on the BioPredictive server in France. The same demographic and six analyte data reported by LabCorp was entered into the calculators to determine the FibroTestª and ActiTestª scores. The scores were compared to those reported by LabCorp to determine agreement and accurate performance.

In addition, for FibroTestª an equation was available on-line (http://hepcbc.ca/fibrotest-fibrosure-in-usa/ accessed 5/30/2014) and this equation (see below) was also used to calculate a FibroTestª score. No equation was available for ActiTestª.

A total of 80 patient results were recalculated through the BioPredictive portal (http://tests.sandbox.biopredictive.com/). The data was also used to calculate the FibroTestª score using the FibroTestª equation obtained from http://hepcbc.ca/fibrotest-fibrosure-in-usa/ .

The Data demonstrated that of the 80 samples referred to Labcorp, a fibrosis score could be generated for 76 samples. FibroSure (FibroTestª) agreed with the BioPredictive server, Quest Diagnostics server and the published equation in 75, 74 and 76 samples, respectively. (Note, for 4 of the 80 samples results, the fibrosis score could not be generated because analytes fell outside acceptable parameters for the algorithm.) In the samples that showed a difference, the scores were within 0.01 of the Labcorp score and in only one case (0.72 vs. 0.73) did this difference cause a categorical change in the Metavir score, namely F3 to F3-F4. Of the 73 samples with a Labcorp Necroinflammatory Activity (ActiTestª) Score (of the 80 TSO samples 5 were not calculated and 2 were not ordered), 72 and 73 , respectively, agreed with the scores calculated by BioPredictive and Quest Diagnostics. The one sample that differed in the BioPredictive calculation was lower by 0.01, but did not change the Metavir activity score.

Between BioPredictive and Quest Diagnostics there was a 97% (77/80) and 99% (79/80) agreement between the FibroTestª and ActiTestª scores, respectively. Differences were all 0.01 and in only one patient did this result in a different Metavir score, F3 (0.72) vs F3-F4 (0.73), respectively. The slight difference in scores is most likely a reflection of rounding that occurs in the conversion of units for the total bilirubin analyte from mg/dL to umol/L in the algorithm.

Source: Dr. Stanley Naides, Quest, Inc.
CPT coding 81599-90
Last Updated 1/14/2016 9:43:54 AM
Entry Number 1660
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