Molecular
Molecular

ALINITY m HBV Assay

alinitym_hbv_assay.png

Accurate quantitation is critical to guide therapy and monitor Hepatitis B (which is important in limiting the spread of infection). The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum.

  • State of the art assay design shaped by the information obtained from the Abbott Global Surveillance Program lead to a dual probe assay with highly conserved target region of the virus.
  • Sensitive quantitation across all genotypes for accurate therapy and viral load monitoring.
  • Specificity with broad dynamic range ensures no carryover up to log 8.   
intended use
 

The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing and monitoring response to treatment. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for HBV, or as a diagnostic test to confirm the presence of HBV infection.

SPECIFICATIONS
 
ALINITY m HBV ASSAY PERFORMANCE  
 Limit of Detection (LoD)

 

Plasma: Probit analysis is 6.72 IU/mL [95% CI 5.28 to 9.27 IU/mL]

Serum: Probit analysis is 9.62 IU/mL [95% CI 7.14 to 14.43 IU/mL

LoD is 10 IU/mL in plasma and serum 
 Linear Range 7 IU/mL to 2,000,000,000 IU/mL   
 Precision <0.22 Total SD  
 Specificity 100.0% (95% CI: 99.3 to 100.0%)  
 Target Region Surface Antigen gene   
 Genotype Detection A, B, C, D, E, F, G, H, and I 
 Specimen Type

 

Plasma: Acid Citrate Dextrose (ACD); K2EDTA; K3EDTA, Plasma Preperation Tubes (PPT)*

Serum: Serum; Rapid clot tube (z-clot, thrombin, and similar); Serum separator tubes (SST)*

*Gel tubes  
 Standardizaiton 3rd World Health Organization (WHO) International Standard [NIBSC code: 10/264; genotype A]  
 Internal Control Yes 
 Carryover 0.0% (95% CI: 0.0 to 1.0%)
 Sample Input Volume 300 µL 

 

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