Cowingene HPV (2+16) Detection Kit
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ORDER INFORMATION |
REF TYPE PACKAGE |
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HP01021X Liquid 48tests/kit |
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HP01022X 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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TARGET SEQUENCE |
E6E7,L2L1 |
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ANALYTICAL SPECIFICITY |
Human Papillomavirus 16, 18 genotype, Others ( 31, 33, 35, 39, 45, 51, 53, 56, 58, 59, 66, 73, 82) |
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ANALYTICAL SENSITIVITY (LoD with probability 95 %) |
reaches up to 100 cp/ml with the probability of 95 % (on HPV DNA control, GeneWell) |
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EXTRACTION/INHIBITION CONTROL |
PCR inhibition and DNA extraction efficiency control by Internal Control (IC) |
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REPORTING UNITS |
cp/ml |
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VALIDATED SPECIMEN |
urine,cervical 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 |
90mins 80mins |
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DIAGNOSTIC SPECIFICITY |
100.00 % (CI95%: 97.12 % – 100.00 %) 100.00 % (CI95%: 95.35 % – 100.00 %) |
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DIAGNOSTIC SENSITIVITY |
100.00 % (CI95%: 96.35 % – 100.00 %) 100.00 % (CI95%: 97.25 % – 100.00 %) |
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VALIDATED EXTRACTION METHOD |
Cowingene Viral DNA/RNA Column |
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Cowingene Sample release reagent |
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APPLIED INSTRUMENTS |
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System |
QuantStudio™ 3 / 5 Real-Time PCR System |
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Applied Biosystems 7300 / 7500 Real-Time PCR System |
Rotor-Gene™ 3000 / 6000 / Q |
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SLAN® Real-Time PCR System |
MA-9600P/MA-6000 Real-Time Quantitative Thermal Cycler |
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LightCycler® 480 |
LineGene 9600 Plus |
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croBEE™ Real-Time PCR System |
Gentier 96E/96R Real-Time PCR System |
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AriaMx Real-Time PCR System |
Mic qPCR Cycler |
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BioQuant-96 Real-Time PCR System |
AMPLilab Real-Time PCR System |
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REQUIRED DETECTION CHANNELS |
FAM, HEX，ROX，CY5 |
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