VIKIA® anti-HCV

Rapid Hepatitis C screening in all settings

VIKIA® anti-HCV is a rapid test used for screening and as an aid in the diagnosis of Hepatitis C infections.

  • 100% sensitivity and 99,7% specificity
  • Simple to use for results in just 10 minutes
  • Validated for near-patient testing

Accessible Testing – Excellent Performance – A Complete Solution for the Diagnosis of Hepatitis

Viral hepatitis caused 1.34 million deaths worldwide in 2015 according to the WHO, a burden comparable to tuberculosis and higher than HIV1. Globally, approximatively 399 000 people die each year from HCV (Hepatitis C Virus)-related complications, including cirrhosis, hepatocellular carcinoma1. In most cases, acute hepatitis C infection is completely asymptomatic; then, most newly infected people are unaware of their infection. Of the 71 million persons living with HCV infection globally in 2015, only 20% knew their diagnosis1, a figure that is estimated to drop below 5%  some countries2. As a result, patients frequently present with already advanced disease at time of diagnosis. Increasing access to efficient diagnostics is one of the key steps towards reducing incidence and mortality of hepatitis C.

VIKIA® anti-HCV is a rapid immunochromatographic test for the qualitative detection of IgG antibodies to the 6 major genotypes of hepatitis C virus in whole blood, serum or plasma. It can be easily performed by health-care professionals in near-patient settings, or if limited laboratory resources are available, thus facilitating screening and linkage to treatment.

Accessible Testing

  • No laboratory facilities required
  • All the material required to perform the test included in the kit
  • Easy to perform:

Only 1 sample drop (15µL) needed: whole blood, plasma or serum

Simple steps

Easy reading of test result at only 10 minutes

 

  • Internal quality control: a blue line appearing in the control region (C) confirms proper sample migration
  • Long shelf life
  • Validated for use with all anticoagulant collection tubes: EDTA, sodium heparin, lithium heparin, lithium heparin and separation gel

Excellent Performance

A study carried out on samples covering all the 6 HCV major genotypes showed maximal sensitivity and very strong specificity with all matrices tested3:

Diagnostic sensitivity: 100% on venous whole blood and plasma
Diagnostic specificity: 99.7 % on venous whole blood
99.6% on plasma
Diagnostic specificity for blood donors: 100% on venous whole blood and plasma
Diagnostic specificity for pregnant women: 100% on venous whole blood and plasma
99.6% agreement between near-patient testing and laboratory testing

A Complete Solution for the Diagnosis of Hepatitis

bioMérieux offers a comprehensive range of serological assays for screening, routine and confirmation testing of hepatitis A, B, C and E. Choose the most appropriate tests according to your settings and needs:

Meeting different needs

Screening, Diagnosis, Follow-up

 

Rapid diagnostic tests

Benchtop solution
Enzyme immunoassays

VIKIA®

VIDAS®

 

 


References:

1. World Health Organization. Global hepatitis report, 2017.

2. World Health Organization. WHO Guidelines on hepatitis B and C testing, 2017.

3. Lewis L. , et al. Performance Evaluation of VIKIA® anti-HCV, Rapid Test for the Qualitative Detection of Antibodies anti-HCV in European and non-European Populations. Poster presented at Journée Nationale de la SAMIC, Alger, November 2017.

VIKIA® anti-HCV

Reference

420005

Contents of the kit

Each kit includes:

  • 25 individually-sealed pouches each containing a ready-to-use test device, a pipette and a desiccant
  • 1 buffer bottle
  • Quick user guide printed on the box

Package insert provided in the kit and downloadable from www.biomerieux.com/techlib

Sample type

Whole blood (by fingerstick or venipuncture), serum or plasma

Sample volume

1 drop (15 µL)

Time to result

10 minutes
Do not interpret the result after 35 minutes

Storage temperature

2 – 30°C

Shelf life

30 months from date of manufacturing

 

GUIDELINES

Please consult your local bioMérieux representative for product availability in your country

Pioneering diagnostics