Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit (Lyophilized)

REF: GI04022X validated specimen: Feces, Vomit Analytes: Enterovirus Universal, EV71 and CoxA16

Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit (Lyophilized)


 
Intented Use

The Cowingene Enterovirus Universal, EV71 and CoxA16 Detection Kit (EV/EV71/CA16 Detection Kit) is an in vitro diagnostic test for the qualitative detection of RNA from Enterovirus Universal, EV71 and CoxA16 in patient specimens. The test utilizes amplification of target RNA by the Polymerase Chain Reaction (PCR) for the detection of Enterovirus Universal, EV71 and CoxA16 in one analysis. The test specifically identifies Enterovirus Universal, EV71 and CoxA16.The validated specimen including feces, vomit. 

The collected specimen should be tested as soon as possible. If the specimens can not be tested immediately, please store them at 2-8℃ for no more than 7 days, below-18℃ for no more than 6 months, below-70℃ for a long time. The number of repeated freezing and thawing should be no more than 5 cycles.

 

 

Order Information

ÁRBITRO Product Name Type Package Size
GI04022X Kit de detección universal de enterovirus de Cowingene, EV71 y CoxA16 Liofilizado 48 tests/kit

 

Specification

Detection Target
Enterovirus Universal, EV71 and CoxA16
Certification
CE- IVD
Storage
2-30℃ for 18 months
LoD
Enterovirus Universal: 400 copies/mL.
EV71: 400 copies/mL.
CoxA16: 400 copies/mL.

Validated Specimen
Feces, Vomit
Compatible Instruments
Open real time PCR machine with channels FAM, VIC/HEX, ROX, CY5, i.e. ABI 7500, Roche 480, Bio-Rad CFX96, etc.

 

Performance Characteristics

1. Use the kit to detect the company positive reference panels and company negative reference panels, and the results should all meet the test requirements. 

2. Repeatability: Use the kit to detect the repeatability reference panels and CV≤5% should be calculated based on the Ct (n=10). 

 

Storage and Handling Requirements

A. Reagents can be stored at 2-30℃ for 18 months.
B. Reagents can be transported at 2-30℃ for no more than 15 days.
C. Do not use reagents past expiration date indicated on outside of package.
D. Protect from light.
E. Once opened, Buffer Lypbeads is valid for 7 days at 2-8℃.
F. Once added PCR Solution, positive control, negative control and Primer Lyobeads are valid for 7 days at 2-8℃, 1 month below -20℃. Repeated freezing and thawing should be limited to 10 cycles.

 

Recommended Supporting  Reagents

ÁRBITRO Product Name Certification Package Size
CW10021Y Columna de ADN/ARN viral de Cowingene CE 50 tests/kit
CW05021X Cowingene DNA/RNA Extraction kit CE 48 tests/kit

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