Amplichek I

Amplichek I is a multi-analyte quality control designed to monitor the performance of in vitro nucleic acid test systems for HIV-1, HBV and HCV viral load assays with multiple levels. Levels include negative, high positive and two low positive levels targeted for Roche and Abbott Platforms.

Amplichek I is the first assayed control that provides values (means and ranges) on these major platforms.

This product is not intended for use with blood donor screening assays in the U.S. or Canada.

Specifications

  • Liquid, human plasma matrix–similar to patient samples
  • 12 month shelf life at -20° to -70°C
  • 7 day open vial stability at 2-8°C or three vial entries, whichever comes first
  • Contains inactivated viral particles to control all analytical steps–provides increased safety and reproduces the steps involved in the analytical process, including nucleic acid extraction

Analytes

  • Hepatitis B Virus (HBV)
  • Hepatitis C Virus (HCV)
  • Human Immunodeficiency Virus Type 1 (HIV-1)

  • Refer to myeinserts.com or the package insert of currently available lots for specific analyte and stability claims.

Ordering Information

Catalog # Amplichek I Configuration
12000527 Negative 10 x 1.2 mL
12000528 Level 1 10 x 1.2 mL
12000529 Level 2 10 x 1.2 mL
12000530 Level 3 10 x 1.2 mL
12000531 4 Level MiniPak (one of each level) 4 x 1.2 mL

Product Level Selection Information

Level
Manufacturer/Assay(s) Negative Level 1
(Low Positive)
Level 2
(Low Positive)
Level 3
(High Positive)
Roche
COBAS® AmpliPrep
COBAS TaqMan® HBV Test v2.0
COBAS® AmpliPrep
COBAS TaqMan® HCV Test
COBAS® AmpliPrep
COBAS® TaqMan® HIV-1 Test v2.0
Abbott Diagnostics
m2000 RealTime HBV
m2000 RealTime HCV
m2000 RealTime HIV-1

See package insert for assay values for each platform.