VERSANT HCV RNA Qualitative Assay (TMA)

Most Sensitive HCV RNA Detection Assay*

VERSANT HCV RNA Qualitative Assay (TMA)
 
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The VERSANT® HCV RNA Qualitative Assay is indicated for use with individuals with antibody evidence of HCV infection with evidence of liver disease, and individuals suspected to be actively infected with HCV with antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.

 

The VERSANT HCV RNA Qualitative Assay is indicated for use in individuals:

  • With antibody evidence of hepatitis C virus (HCV) infection with evidence of liver disease
  • Suspected to be actively infected with HCV with antibody evidence
  • At risk for HCV infection with antibodies to HCV

 

 

Sensitivity of the VERSANT HCV RNA Qualitative Assay (TMA) was determined by testing serial dilutions of the WHO International for HCV genotype 1 RNA (NIBSC code 96/790). Dilutions were prepared at 0.1, 1, 2.5, 5, 7.5, 10, 18.5 and 50 IU/mL in normal serum.

 

The Limit of Detection (LOD) was defined as the concentration detected 95% of the time, and was calculated to be 5.3 HCV RNA IU/mL for the TMA assay. 45 IU/mL for the AMPLICOR 2.0 assay and 32 IU/mL after the resolution of gray zone results (13% of the total results).

SMNTMA REAGENT 
10317270VERSANT® HCV RNA Qualitative Assay IVD Box 1+2+3100 tests
10315712VERSANT® HCV RNA Qualitative Assay Auto-Detect500 tests
10322708VERSANT® HCV RNA Qualitative Assay Controls8 Series
10321503Kit Proficiency Panel HCV10 x 3.25mL
 TMA CONSUMABLES 
10341127VERSANT® HCV RNA Qualitative Assay-Tips (Ten Tips Cassette)1000 Tips
10325580VERSANT® HCV RNA Qualitative Assay-Sealing Cards35 Cards
10341164VERSANT® HCV RNA Qualitative Assay Tubes (Ten Tube Units)1000 Tubes

 


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