RealTime HCV Genotype II

CE Marked

For In Vitro Diagnostic Use

Abbott Molecular offers consolidated hepatitis testing of both HCV genotype and viral load on the fully automated Abbott m2000sp/rt platform. The Abbott Realtime Genotype II assay determines the genotypes of hepatitis C virus in plasma and serum of HCV-infected individuals.

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Description
 

The Abbott RealTime HCV Genotype II provides:

  • >97.59% accuracy in HCV GT detection
  • >95% GT 1a, 1b subtyping 

The Abbott RealTime HCV Genotype II assay consists of 2 reagent kits: 

  • Abbott RealTime HCV Genotype II Amplification Reagent Kit
  • Abbott RealTime HCV Genotype II Control Kit

Assay Accuracy

The accuracy of the Abbott RealTime HCV Genotype II assay was demonstrated by testing 169 HCV genotype 1 (110 of genotype 1a, 58 of subtype 1b, and 1 genotype 1 only), 41 HCV genotype 2,  27 HCV genotype 3, 28 HCV genotype 4, 14 HCV genotype 5, and 12 HCV genotype 6 positive specimens. Nucleotide sequencing was used to determine the reference genotype of each specimen tested.

 

HVC GENOTYPE/SUBTYPE NUMBERS SAMPLES TESTED NUMBERS SAMPLES CORRECTLY IDENTIFIED DETECTION RATE (%)
1* 169 169 100.00
1a** 110 107 97.27
1b*** 58 56 96.55
2 41 41 100.00
3 27 27 100.00
4**** 28 28 89.29
5 14 14 100.00
6 12 10 83.33
1 though 6‡ 291 286 98.28
* Denotes analysis based upon samples tested with m2000rt results: 1, 1a, 1b, 1/1a, and 1/1b.
** Three out of 110 subtype 1a samples were identified as genotype 1 only but not as subtype 1a.
*** One vendor identified subtype 1b sample was excluded from analysis because it was identified by sequencing as genotype 1 only. Two out of 58 remaining subtype 1b samples were identified as genotype 1 but not as subtype 1b.
**** Genotype 4 was detected in all 28 samples. Genotype 1 was also detected in 3 of the samples, which could not be resolved due to 2-way cross-reactivity.
‡ Denotes analysis based upon genotypes 1, 2, 3, 4, 5, and 6 combined.
 

Intended Use

The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for determining the genotype(s) of hepatitis C virus (HCV) in plasma and serum from HCV-infected individuals. The Abbott RealTime HCV Genotype II assay detects genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b through the use of genotype-specific fluorescent-labeled oligonucleotide probes. The Abbott RealTime HCV Genotype II is not for screening blood, plasma serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection.

References

1. Abbott RealTime HCV Genotype II [package insert]. Abbott Laboratories, 2013.

 

Design
 

Target Region

The Abbott RealTime HCV Genotype II assay detects genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b through the use of genotype-specific fluorescent-labeled oligonucleotide probes. It targets the 5'UTR for the classification of HCV genotypes 1, 2, 3, 4, 5, and 6, and the NS5B region to accurately subtype HCV genotypes 1a and 1b.  

The Abbott RealTime HCV Genotype II Target Region

The Abbott RealTime HCV Genotype II assay uses 5'UTR as well as NS5b region for broader subtype identification  
 

Genotype Detection

The assay requires three separate reactions per sample to detect genotypes 1,2,3,4,5, and 6 and subtypes 1a and 1b:

  • Reaction A is designed to detect all HCV isolates, subtype 1a isolates, and genotype 3 isolates.
  • Reaction B is designed to detect genotype 2 isolates, subtype 1b isolates, and genotype 1 isolates.
  • Reaction C is designed to detect genotype 4 isolates, genotype 5 isolates, and genotype 6 isolates.
 
Specifications
 

 

 
Abbott RealTime HCV Genotype II assay performance*
Sensitivity 500 IU/mL (0.5 mL prep)
Specificity 100%**
Target Region 5'UTR & NS5b
Genotype Detection 1a (NS5b), 1b (NS5b), 1, 2, 3, 4, 5, 6 (5'UTR)
Standardization Second World Health Organization Standard for Hepatitis C Virus RNA
Internal Control Yes; processed through sample prep with each sample
External Control Yes; Negative, Positive
Results Reported Qualitative - Genotype Call
*Performance data shown from internal verification.
**The specificity of Abbott RealTime Genotype II was evaluated by testing 100 HCV serologically negative plasma specimens. All negative specimens tested were interpreted as HCV RNA negative by the Abbott RealTime HCV Genotype II assay, resulting in 100% specificity. 

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