WizDx™ RSV CrystalMix PCR Kit is intended to be used the achieve qualitative detection of Respiratory Syncytial Virus extracted from nasopharyngeal swabs, oropharyngeal swabs, and sputum from patients.
MFDS License No. : IVD-21-914
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Target genes | RSV L gene |
Internal control | Human beta-actin gene |
Positive control | Included |
Turnaround time | < 40 minutes from extracted RNA to end results (using CLEO™ Q16) |
Validated sample type | Sputum, oropharyngeal swab, and nasopharyngeal swab samples |
Technology | Real-time PCR |
Type of analysis | Qualitative |
Analytical specificity | RSV A 100%, RSV B 100% |
Analytical sensitivity (LOD) | RSV A 100 copy/rxn, RSV B 100 copy/rxn |
Linear range | 1x105 ~ 1x102 copy/rxn with precision ± 0.5 log |
Reagent form | Freeze-dried, corn shape |
Compatible real-time PCR instruments | CLEO™ Q16, Bio-Rad CFX96, ABI QuantiStudio |