RevoDx HDV qPCR Kit (quantitative)

Intended Use

RevoDx HDV qPCR Kit is a real-time PCR test intended for quantification of Hepatitis D virus (HDV) RNA in human serum or plasma (EDTA) using RevoDx Viral Nucleic Acid Purification Kit and BIO-RAD CFX96 or Tianlong Gentier 96 Real-Time PCR Detection System for amplification, detection and analysis. RevoDx HDV qPCR Kit is intended to assist in the management of patients with chronic HDV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. RevoDx HDV qPCR Kit is not intended to screen blood and blood products for the presence of HDV RNA or to confirm the diagnosis of infection with HDV.

Negative results do not preclude HDV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

RevoDx HDV qPCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

 

Instruments

The RevoDx HDV qPCR Kit is to be used with BIO-RAD CFX96 and Tianlong Gentier 96 Real-Time PCR Detection Systems. But the RevoDx HDV qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM and HEX

Features

• Validated for use with fresh or frozen human serum or plasma collected in EDTA anticoagulant.

• Quantification Standards ranging from 1 x 104 IU/mL to 1 x 107 IU/mL

• Exogenous internal control

• The Limit of Detection (LoD) value is 47 IU/mL

• Linear range is between 56 IU/mL and 1 x 109 IU/mL

• Diagnostic specificity is ≥ 99 %

• Whole system failure rate is ≤1 %

• For research use only