Alinity m HBV Assay

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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

  • Research Driven Robust Assay Design
    State of the art assay design fueled by the information obtained from the Abbott Global Surveillance Program led to a dual probe assay with highly conserved target region of the virus thus safeguarding against future viral evolution.  High sensitivity and specificity across all genotypes (A-I) provide confident results that guide patient care.
  • Broad Dynamic Range
    Helps avoid dilution of high viremic samples and improves turnaround time.
  • Clinical Relevance
    Highly accurate assay results meet AASLD guidelines and assure suppression of hepatitis B virus to prevent resistance development.

icon-link.pngInstructions for Use

VIEW ORDERING INFORMATION

* Global Hepatitis Report 2017 (WHO 2017) 
Product Details
 

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 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

  • Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert).
  • Human serum (including serum separator tubes and rapid-clot tubes) and plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m HBV assay. The use of other plasma and serum tubes have not been evaluated.
  • Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
  • Debris within serum and plasma specimens (e.g., clots, fibrin strands) may interfere with sample processing.
  • Assay performance for determining the clinical stage of HBV infection has not been established.
  • The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in this package insert.

For in vitro diagnostic use

Rx Only

 

specifications
 

 

ABBOTT ALINITY m HBV ASSAY PERFORMANCE1-5
Technology Polymerase chain reaction (RT-PCR)
Claim Monitoring
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
Genotypes A-I
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
1. Alinity m HBV AMP kit PI: 53-608162/R1; 2. Alinity m HBV CAL Kit PI: 53-608163/R1; 3. Alinity m HBV CTRL Kit PI: 53-608164/R1. 4. Data on file at Abbott; 5. Alinity m Operations Manual 54-605001/R9
* NIBSC code: 10/264; genotype A
 
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