HEPATITIS C

Abbott RealTime HCV

For more information, contact Abbott.

PRODUCT NAME UNIT SIZE ORDER NUMBER GTIN


For HCV management, especially given the high cost of therapies, excellent performance at clinical decision points is critical for providing reliable results (at 25 IU/ML) to assess SVR. The Abbott RealTime HCV assay delivers accurate quantification of GT 1-6 using human serum, plasma, and now also available for Dried Blood Spot (DBS) sample .

To learn more about the Abbott RealTime HCV please visit: https://www.molecular.abbott/int/en/products/infectious-disease/realtime-hcv-viral-load

ABBOTT REALTIME HCV PERFORMANCE*
Sensitivity462 IU/mL for the 70 µL sample volume (DBS)
12 IU/mL for the 500 µL sample volume (Plasma/Serum)
30 IU/mL for the 200 µL sample volume (Plasma/Serum)
Linear Range462 IU/mL to 1.0E+08 IU/mL (DBS)
12 IU/mL to 1.0E+08 IU/mL (500 µL Plasma/Serum)
30 IU/mL to 1.0E+08 IU/mL (200 µL Plasma/Serum)
Precision≤ 0.25 log IU/mL SD from 1.0E+04 to 1.0E+08 IU/mL (DBS)
≤ 0.25 log IU/mL SD from 100 to 1.0E+08 IU/mL (Plasma/Serum)
SpecificityOverall: 100%
Genotype DetectionAccurate quantification of genotypes 1, 2, 3, 4, 5 and 6
StandardizationSecond World Health Organization international standard for HCV RNA (NIBSC 96/798)
Internal ControlArmored RND (Pumpkin kinase)
Calibrator2 Calibrator levels - single use tubes
ControlOne negative, one low positive and one high positive control

*Abbott RealTime HCV Package Insert 51-602124/R12 and Abbott Realtime HCV with DBS Package Insert 51-608440/R1.