Clinical Diagnostics
HIV-1 DNA Test PRO
The HIV-1 DNA Test PRO is intended for the qualitative and quantitative detection of HIV-1 DNA using real-time PCR that is to date the most sensitive and reproducible technology for the monitoring of HIV-1 persistence in infected cells.
HIV-1 DNA Test PRO allows the simultaneous amplification of HIV DNA and human Telomerase Reverse Transcriptase (hTERT).
The endogenous gene allows to verify DNA extraction success, to determine the presence of PCR inhibitors and to obtain HIV DNA copies without cellular DNA quantification.
The HIV DNA provides an overall quantification of all viral forms of HIV-1 DNA: stable integrated proviruses and extrachromosomal forms, including both circular (1-LTR and 2-LTR) and linear forms, each playing a different role in HIV replication and pathophysiology.
The evaluation of this marker at different stages in the history of infection can help clinicians to choose the best therapeutic strategies and to control the progression of HIV infection.
Moreover HIV-1 proviral DNA detection is indicated for HIV diagnosis in infants borni to infected mothers below 2-years of age: serology may remain positive due to passive transfer of antibodies through placenta.
The detection of proviral DNA is a sensitive and specific way of diagnosing HIV infection and is a very useful adjunct test in the context of primary infection in those with negative or indeterminate serology.
Advantages
Superior performance: Accurate detection and quantification of HIV-1 DNA using an amplification mix with a technology that neutralizes a broad spectrum of PCR inhibitors that compromise assay performance with whole blood
Reliability: The amplification of the endogenous gene hTERT reveals the presence of inhibitory factors in the sample
Compatibility: Highly consistent results on various real-time cyclers in terms of sensitivity, reproducibility and efficiency
Ease of use: Minimal hands-on time
Speed: Less than 3 hours from sample to result
Convenience: PCR mix and standard curve ready to use. DNA quantification is not necessary to obtain HIV-1 DNA copies because of the endogenous gene amplification.
Specifications
Type of samples: Whole blood or lymphocytes Target gene LTR (HIV gene) hTERT (endogenous gene)
Limit of quantification: 5 HIV-1 DNA copies/PCR well 34 HIV-1 DNA copies/106 cells
Limit of detection: 4 HIV-1 DNA copies/PCR well 27 HIV-1 DNA copies/106 cells
Linear range: 50 – 5 000 HIV-1 DNA copies/PCR well
Internal Control: in each sample Detects the presence of inhibitors in the sample allowing to check the validity of negative results and to guarantee the accuracy of DNA quantification
Thermal cycler compatibility: Require qPCR cycler with filter sets for FAM™ and VIC/HEX/JOE dyes
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