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Test Code:
HEPCGENO

Order Name:
HCV Genotype

 
Useful For:
This test is used to identify Hepatitis C virus (HCV) genotypes 1 to 6 and subtypes a and b of genotype 1 in human serum samples to guide the selection of treatment type and length for individuals being considered for antiviral treatment who are chronically infected with HCV
 
Methodology:
  1. Reverse transcription-polymerase chain reaction (RT-PCR)
  2. Reverse hybridization assay
 
AliasesName:
HCVG
HCV Genotyping
 
 
 
Test Code:
HEPCGENO

Order Name:
HCV Genotype

 
Collection Specimen Or Container:
Blood/ Plain blood (Red top) 6 mL, 1 tube
 
Specimen Testing Type:
Serum, minimum volume 1 mL
Separate serum within 4 hours of collection.
 
Sub Mission Container:
Plastic tube
 
Rejection Criteria:
Hemolysis: Mild OK; Gross reject
Lipemia: Mild OK; Gross reject
Icterus: Mild OK; Gross reject
Other: Heparin, anticoagulant blood will be reject.
 
Specimen Stabillity:
Specimen Type Temperature Time
Whole blood Room temperature, 18oC to 25oC 4 hours
Serum Refrigerated, 2oC to 8oC 48 hours
Frozen, -15oC to -25oC 72 hours
 
 
 
Test Code:
HEPCGENO

Order Name:
HCV Genotype

 
Method detail:
1. Reverse transcription-polymerase chain reaction (RT-PCR)
2. Reverse hybridization assay
 
Schedule:
Tuesday and Friday, at 08:00 a.m.
 
Turnaround Time:
Received specimen to reported within 4 days.
 
Performing Location:
Molecular biology & Genetics, Laboratory Department Tel.14168
 
Specimen Retention Time:
2 months
 
 
 
Test Code:
HEPCGENO

Order Name:
HCV Genotype

 
 
Clinical Information:
The Hepatitis C viral genome is highly variable and is classified into 6 genotypes groups, or clades, based on phylogenetic analyses of the genomic sequence. These genotype groups differ at 31% to 34% of their nucleotide sequence positions and about 30% of their amino acid sequence positions. Each genotype contains one or more HCV subtypes or variants. In recent years, the clinical utility of HCV genotyping has been established. Published studies and recommendations from national agencies have concluded that accurate determination of genotype is important in the management of patients considering anti-HCV treatment.
 
Reference Value:
Not Detected
 
Interpretation:
  1. Incorrect test results may occur from improper specimen collection, handling or storage, technical error, sample mix-up or because the number of organisms in the specimen is below the analytical sensitivity of the test.
  2. Logistic regression analysis shows that specimens with HCV viral loads as low as 2,106 IU/mL produce reliable results when analyse by this test.
  3. In rare cases uninterpretable patterns may be produced. These may be due to the sequence heterogeneity of the HCV genome, mixed infections or cross contamination. Recently, recombinant HCV isolates have been identified. Recombinant strains are rare. The performance characteristics have not been established for this assay using recombinant strains. Depending on the site of recombination the assay may give an uninterpretable result or a genotype for one of the parent strains of the recombinant virus.
 
Clinical Reference:
Manufacturer’s package insert, VERSANT® HCV Genotype 2.0 Assay (LiPA), November 2017, Siemens Medical Solutions Diagnostics, NY 10591-5097 Tarrytown, USA.