Accurate HBV viral load test results are critical in assessing if patients are responding to treatment. This is vital in pursuing the elimination of viral Hepatitis as a public threat by 2030 worldwide*. Alinity m HBV assay delivers accurate and timely viral load results which help clinicians guide patient care with improved workflow efficiency needed in molecular laboratory
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 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, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm the presence of HBV infection.
LIMITATIONS OF THE PROCEDURE
For in vitro diagnostic use
|ABBOTT ALINITY m HBV ASSAY PERFORMANCE1-5|
|Technology||Polymerase chain reaction (RT-PCR)|
|Time to first result||< 115 min|
|Standardization||3rd World Health Organization (WHO) International Standard for Hepatitis B Virus|
|Probe Design||Dual probe design with single stranded linear probes|
|Target Region||Surface Antigen gene|
|Specimen Types||Plasma: Acid Citrate Dextrose (ACD); K2EDTA; K3 EDTA, Plasma preparation Tubes (PPT)
Serum: Serum; Rapid clot tube (z-clot and thrombin); Serum separator tubes (SST)
|Sensitivity / Limit of Detection (LoD)||LoD= 10 IU/mL in plasma and serum
Plasma: Probit Analysis determined that the concentration of HBV DNA detected with 95% probability was 4.29 IU/mL (95% CI: 3.61 to 5.34 IU/mL)*
Serum: Probit Analysis determined that the concentration of HBV DNA detected with 95% probability was 6.85 IU/mL (95% CI 5.44 to 9.19 IU/mL)*
|Linearity||10 IU/mL to 1,000,000,000 IU/mL (1.00 to 9.00 Log IU/mL)|
|Result Units||IU/mL or Log IU/mL|
|Precision||Total SD ≤ 0.30 log IU/mL for plasma and serum|
|Sample input volume||300µL|
|Specificity||100.0% (95% CI: 99.2 to 100.0%)|
|Internal control||DNA (Pumpkin)|
|Calibrator||2 Calibrator levels-single use tubes|
|Controls||Negative, Low Positive, and High Positive controls-single use tubes|
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