An Authorized Distribution Partner

MASA is an Authorized Distribution Partner in the USA and other Regions for the Products of Coyote Bioscience Co., Ltd. and Coyote Bioscience USA.

The Flash 20 Real-Time PCR system is designed for molecular diagnostic market. It has a small footprint, with high detection sensitivity. Real-time PCR, also called quantitative PCR or qPCR, can provide a simple and elegant method for determining the amount of a target sequence or gene that is present in a sample.  

Key Features:

• Breakthrough the Speed Limit by Molecular Reactions in Parallel
• Fastest Sample to Answer Time in 30 min (Flash 20)
• Comparative Sensitivity and Specificity with Standard QPCR Assay
• CFDA , CE approval
• More than 500 Clinical Samples Validated (FDA EUA and WHO EUL submitted)
• Random Access

A real-time polymerase chain reaction is a laboratory technique of molecular biology based on the polymerase chain reaction (PCR), which is used to amplify and simultaneously detect or quantify a targeted DNA molecule. The key feature is that the amplified DNA is detected as the reaction progresses in "real time". This is a new approach compared to standard PCR, where the product of the reaction is detected at its end.  The Flash 20 Real-Time PCR system is a robust, unique and as precise as any large-scale apparatus. Our system provides you with precise test results quickly and cost effectively anywhere, anytime.

The Flash 20 PCR platform presents, in addition to the low cost, a simple, rapid and accurate, Point-of-Care Testing (POCT) molecular diagnostic platform by eliminating the reliance on the complex, time-consuming, and error-prone nucleic acid extraction and purification processes of the Conventional PRC test. 

Quality is at the forefront of what Coyote does from beginning to end, from the start of the design passes to delivery of a product to its customers. Coyote complies with applicable regulatory requirements and employ a meticulous quality management system. .

MASA is an MASA is an Authorized Distribution Partner in the USA and other Regions for the Products of Coyote Bioscience Co., Ltd. and Coyote Bioscience USA.

CFDA, CE Approval ( (FDA EUA and WHO EUL submitted)

1. Product model/specifications and description of classification 24 tests/ kit,  48 tests/ kit、96 tests/ kit.

2, Performance indexes

2.1  Visual inspection:
Packing Sound, Clear legibility of the label, Reagent tube not broken.

2.2  Positive Coincidence Rate
Testing results of DirectDetectTM SARS-COV-2 Detection Kit(PCR-Fluorescence

 Probe) Positive References (P1 to P9) should be both positive for 2019-nCoV ORF1ab

and N gene.
2.3 Negative Coincidence Rate

Testing results of DirectDetectTM SARS-COV-2 Detection Kit (PCR-Fluorescence Probe) Negative Reference (N1 to N11) should be both negative for 2019-nCoV ORF1ab and N gene.

DirectDetectTM SARS-COV-2 Detection Kit (PCR-Fluorescence Probe) Negative Reference (N1 to N11) detected human-derived components, and the internal standard

test result should be negative. 

2.4 Precision 

Testing results of Enterprise Precision Reference (R1 and R2) shall meet the following requirements.

R1: both positive for 2019-nCoV ORF1ab and N gene. Coefficient of variation (CV,%) of CT value of FAM and ROX channel shall not be greater than 5.0%.

R2: both positive for 2019-nCoV ORF1ab and N gene. Coefficient of variation (CV,%) of CT value of FAM and ROX channel shall not be greater than 5.0%.

Note: CV value calculation needs to be added with 15 (precycling number),

CV=SD(Ct+15)/mean(Ct+15)*100% 

2.5 Limits of detection (LODs)

Testing results of Enterprise LOD References (S1 to S3) should be both positive 1 for 2019-nCoV ORF1ab and N gene.

3. Testing methods

3.1  Visual inspection:
Visual inspection: Results should meet the requirements of 2.1.

3.2  Positive Coincidence Rate

According to the kit instructions, testing result of Enterprise Positive References

(P1-P9) should meet the requirements of 2.2. 

3.3 Negative Coincidence Rate

According to the kit instructions, testing result of Enterprise Negative References

(N1-N8) should meet the requirements of 2.3. 

3.4 Precision

According to the kit instructions, test Enterprise Precision Reference (R1 and R2),

repeat 10 times each, results should meet the requirements of 2.4. 

3.5 Limits of detection (LODs)

According to the kit instructions, testing result of Enterprise LOD Reference (S1 to S3) should meet the requirements of 2.5.

Coming Soon!

Coming Soon!