Sample Transport Kits
Intended Use
RevoDx HBV qPCR Kit is a real-time RT-PCR test intended for quantification of Hepatitis B virus (HBV) DNA in human serum or plasma (EDTA) using RevoDx Viral Nucleic Acid Purification Kit and BIO-RAD CFX96 Real-Time PCR Detection System for amplification, detection and analysis. RevoDx HBV qPCR Kit is intended to assist in the management of patients with chronic HBV infection and to form a strategy for anti-viral therapy in conjunction with all relevant clinical and laboratory findings. RevoDx HBV qPCR Kit is not intended to screen blood and blood products for the presence of HBV DNA or to confirm the diagnosis of infection with HBV.
Negative results do not preclude HBV 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 HBV 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 HBV qPCR Kit is to be used with BIO-RAD CFX96 and Tianlong Gentier 96 Real-Time PCR Detection Systems. But the RevoDx HBV qPCR Kit may also be compatible with most real-time PCR detection systems with the channels FAM and HEX
RevoDx Viral Transport Medium
RevoDx Viral Transport Medium is intended for transport of the viruses in human oropharyngeal swab and nasopharyngeal swab specimens for in vitro diagnostic purposes.
DirEXT Nucleic Acid Extraction Reagent
DirEXT Nucleic Acid Extraction Reagent is intended for transport and rapid extraction of nucleic acids from the viruses in human oropharyngeal swab and nasopharyngeal swab specimens for in vitro diagnostic purposes. The extracted viral nucleic acid is suitable for RT-PCR, qRT-PCR, qPCR, viral detection, viral load determination and viral genotyping.
RevoDx Cervical Specimens Transport Reagent
RevoDx Cervical Specimens Transport Reagent is intended for transport of cervical swab specimens for in vitro diagnostic purposes. Any diagnostic results produced in connection with any downstream diagnostic assay using this reagent should be interpreted according to all relevant clinical and laboratory findings.