Alinity M HCV Assay - Abbott Molecular

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3. Alinity m HCV Assay | Abbott Molecular

ALINITY m HCV ASSAY

For In Vitro Diagnostic Use.

Accurate quantitation is critical to guide diagnosis to cure Hepatitis C. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.

• Dual probe assay within a highly conserved target region of the virus.
• Accurate quantitation across all genotypes provide confidence in tests results.
• Streamlined and concurrent HCV confirmation and viral load result from one sample (plasma or serum) to help provide laboratories and physicians with a solution from Confirmation to Clinical Management.

INTENDED USE SPECIFICATIONS

The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma. The Alinity m HCV assay is intended for use in the clinical management of HCV-infected patients undergoing antiviral therapy in conjunction with clinical presentation and other laboratory markers. The Alinity m HCV assay may also be used as a diagnostic test to confirm active HCV infection. The results from the Alinity m HCV 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 HCV.

 

 

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ALINITY m HCV ASSAY PERFORMANCE
Limit of Detection (LoD)	Plasma: Probit analysis determined that the concentration of HCV RNA in plasma detected with 95% probability was 5.11 IU/mL (95% CI 3.92 to 8.46 IU/mL). ermentum pharetra quam. Serum: Probit analysis determined that the concentration of HCV RNA in serum detected with 95% probability was 5.11 IU/mL (95% CI 4.16 to 7.47 IU/mL).
Linear Range	12 IU/mL to 200,000,000 IU/mL
Target Region	Dual Target targeting 5’UTR
Genotype Detection	1, 2, 3, 4, 5, 6
Confirmatory	Yes
Internal Control	Yes
Specimen Type	Plasma: Acid Citrate Dextrose (ACD); K2EDTA; K3EDTA, Plasma Preperation Tubes (PPT)* Serum: Serum; Serum Separator Tubes (SST)* *Gel tubes
Input Volume	600 µL
Precision	Precision < 0.18 Total SD
Standardization	4th World Health Organization (WHO) [NIBSC code: 06/102; genotype 1]
Specificity	Overall: 100.0% [95% CI: 99.2 to 100.0]

Source: Alinity m HCV AMP kit PI: 53-608062/R9

 

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