HBV Testing with the Alinity m System – A Breakthrough Solution for Monitoring and Treating Hepatitis B

HBV Testing Using Alinity m – A Breakthrough Solution for Monitoring and Treating Hepatitis B

HBV testing with Alinity m is an advanced in vitro PCR test developed to accurately quantify the hepatitis B virus (HBV) DNA in patient plasma or serum.

Precise quantification of HBV levels is crucial for guiding treatment and monitoring the status of hepatitis B, helping control the virus spread and optimizing treatment therapy.

Alinity m System

Key Features of Alinity m HBV Testing

  • Advanced Testing Technology: The Alinity m HBV Assay uses PCR technology to quantify HBV DNA with high sensitivity, aiding in monitoring viral load and adjusting treatment therapies effectively.
  • Modern Test Design: Developed from data collected from Abbott’s Global Monitoring Program, Alinity m HBV uses dual-probe technology with a highly conserved viral target region, ensuring high accuracy in results.
  • Genotype Sensitivity: Accurately tracks all genotypes of the hepatitis B virus, ensuring precise and effective treatment therapy.
  • Application in Chronic Hepatitis B Treatment: Assists doctors in managing chronic hepatitis B patients, measuring HBV DNA levels at initial and throughout treatment, evaluating response, and adjusting therapy.

HBV test via Alinity m system by Lintech JSC

Important Information to Note About Alinity m HBV Testing:

Not for Screening: Alinity m HBV assay is not intended for screening blood, blood products, tissues, or organs for hepatitis B, and is not a diagnostic test to confirm the presence of hepatitis B.
Must Be Evaluated in the Context of All Clinical Information: Test results must be interpreted in the context of all relevant test results and clinical diagnoses.

HBV DNA testing products

Alinity m HBV Test 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 Preparation Tubes (PPT)* Serum: Serum; Rapid clot tube (z-clot, thrombin, and similar); Serum separator tubes (SST)*
Standardization 3rd World Health Organization (WHO) International Standard [NIBSC code: 10/264; genotype A]
Internal Control Yes
Sample Input Volume 300 µL

Hepatitis Disease Diagnosis, Stamps, Stethoscope, Syringe, Blood Test, And Pills
 

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Phone: (+84)2866595477
Website: lintechvn.com
Mail: lintech@lintechvn.com

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