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Digene's CMV DNA Test:
The molecular diagnostic tool of choice for qualitative detection of human cytomegalovirus (CMV)
Digene's Hybrid Capture® CMV DNA Test is the first molecular diagnostic test to be cleared by the U.S. FDA for the qualitative detection of human cytomegalovirus (CMV) DNA in peripheral white blood cells isolated from whole blood. It provides high reproducibility plus optimal sensitivity for CMV DNA detection in individuals at risk for the disease.
The CMV DNA test accurately detects infection in immunosuppressed and immunocompromised patients, such as those who have had solid organ or bone marrow transplants, or who have HIV/AIDS. Due to its accuracy, the CMV DNA test assists physicians in making key decisions that will improve patient management.
Based on Digene's proven Hybrid Capture technology, the CMV DNA test uses a nucleic acid, signal–amplified technique that offers:
- Objective, standardized results reducing uncertainties from subjective interpretation associated with traditional CMV testing methods
- High assay sensitivity and specificity compared to other methods
- Excellent reproducibility
- Effective targeting of pre–emptive therapies
- Elimination of contamination risks associated with target–amplification methods
| Features |
Benefits |
- Easy–to–use, standardized procedures
- Clear, objective results
- Results available in 6 hours
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Improved productivity |
- 700 copies/ml blood limit of detection
- More sensitive than culture techniques
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Optimal sensitivity |
- RNA probe covers 17% of total CMV genome
- No cross reactivity to herpes viruses or human DNA
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Greatly reduces likelihood of
false negatives and positives |
- Blood sample (EDTA) can be stored at room temperature for up to 24 hours and at 4° C for another 24 hours, allowing a total storage time of 48 hours
- Both batch and STAT testing can be conducted
- Specimens staged according to laboratory requirements
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Flexible specimen management
and assay work flow |
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