Cowingene SARS-Cov-2, Influenza A/B And RSV Detection Kit
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ORDER INFORMATION |
REF TYPE PACKAGE |
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RP04021X Liquid 48tests/kit |
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RP04022X Lyophilized 48tests/kit |
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INDICATION |
in vitro diagnostic medical device |
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REGULATORY STATUS |
CE-IVD |
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INTENDED USER |
For professional use in laboratories with trained staff |
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TECHNOLOGY |
Real-time PCR |
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TYPE OF ANALYSIS |
Qualitative |
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ANALYTICAL SPECIFICITY |
SARS-Cov-2, Influenza A/B and Respiratory Syncytial Virus |
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ANALYTICAL SENSITIVITY (LoD with probability 95 %) |
reaches up to 400 cp/ml with the probability of 95 % (on RNA control) |
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EXTRACTION/INHIBITION CONTROL |
PCR inhibition and RNA extraction efficiency control by Internal Control (IC) |
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REPORTING UNITS |
cp/ml |
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VALIDATED SPECIMEN |
Nasopharyngeal Swab |
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TYPE |
Liquid Lyophilized |
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STORAGE |
≤-20℃ 2-30℃ |
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SHELF LIFE |
18months 18months |
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REACTION TIME |
75mins 75mins |
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DIAGNOSTIC SPECIFICITY |
100.00 % (CI95%: 97.57 % – 100.00 %) 100.00 % (CI95%: 97.27 % – 100.00 %) |
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DIAGNOSTIC SENSITIVITY |
100.00 % (CI95%: 96.37 % – 100.00 %) 100.00 % (CI95%: 97.56 % – 100.00 %) |
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VALIDATED EXTRACTION METHOD |
Nucleic Acid Extraction Kit |
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APPLIED INSTRUMENTS |
BioQuant-96 Real-Time PCR System QuantStudio™ 3 / 5 Real-Time PCR System |
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CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System |
Rotor-Gene™ 3000 / 6000 / Q |
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REQUIRED DETECTION CHANNELS |
FAM, VIC/HEX, ROX, CY5, CY5.5/Qusar705 |
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