Acquired FDA certification Acquired certification

Novel Coronavirus (SARS-CoV-2)

Fast Nucleic Acid Detection Kit
(PCR-Fluorescence Probing)
Whole process only in 40 minutes
Non-cold chain to minimize the cooling cost
Contains all components from collection to detection

Product Characteristics
● Immediately detectable: It’s easy to operate, without extraction, and only needs a fluorescence quantitative PCR
instrument, The number of samples in a single test can be adjusted flexibly according to the number of people to be
tested, which is extremely suitable for epidemic screening in communities, stations, airports, customs, supermarkets,
schools and other areas.
● High sensitivity: The minimum detection limit can be as low as 300 copies / ml.
● Fast: Complete the whole process from sampling to detection in 40 minutes.
● Transportation at room temperature : The kit can be stored at room temperature and non-cold chain to minimize the
cooling cost.

Detection Process

1. Collect the sample 2. Put the head of swab into the 3. Take the mixed liquid 4. Put tube into the qPCR
with a pharyngeal virus sampling tube, shake it up and add it to the reaction instrument for detection and
swab and down and mix well amplification tube determination of the result

Product Performance Index

Package 48 tests /box
Detection Methods PCR-Fluorescence Probing (direct amplification)
Detect genes ORF1ab，N
Sample Requirements Pharyngeal swab, Nasal swab, Nasopharyngeal swab
Instrument Compatibility See 'List of Compatible Instruments'
There is no cross-reactivity with positive samples such as coronavirus (NL63, HKU1, 229E, OC43),
Specificity MERS-coronavirus,SARS-coronavirus,influenza A virus, influenza B virus Yamagata type, etc.
The negative control of the testing enterprises were all negative.
Sensitivity Minimum detection limit: 300 copies / ml
Precision The coefficient of variation (CV,%) of the precision Ct value within the batch was ≤5%.
Storage Condition Stored at room temperature,before the kit is opened and used.
Valid Period 12 months

www.cwbiosciences.com info@cwbiotech.com

CoWin Biosciences Co., Ltd

 List of Compatible Instruments
Compatible Instruments List
The following instruments match the fluorescence channels (Including FAM VIC and ROX channel) and tube type
(0.2ml 8-strip tubes) of our kit, so we believe that those instruments are compatible for our kits. However, due to the
performance differences between machines, we suggest that pre experiments be carried out to evaluate these
instruments before formal use.

Brand Model

7500, 7500 Fast Dx, 7300Plus

ABI StepOne, ViiA 7 Dx, QuantStudio Dx
QuantStudioTM 3，QuantStudioTM 5
Bio-Rad CFX96, CFX96 Deep Well, CFX Connect
Suzhou Molarray Co. Ltd. MA-6000, MA-1600Q
EASTWIN EQ164
LEPU medical Lepgen-96
Abbott Laboratories m2000rt
Toneker TK-6000
Ganome GNM-C7-8
FQD-16A
Bioer Technology
FQD-48A、FQD-96A
Dian Diagnostics MC-1000
AGS9600, AGS4800
Bioanyu
AGS8830-8、AGS8830-16
Shanghai Hongshi Medical Technology SLAN、SLAN-48P、SLAN-96S、SLAN-96P
Suzhou Baiyuan Gene Technology ASA-4800, ASA-9600, ASA-9600
Triplex International Biosciences (China) Co.,LTD TIB-8600/8300
Gentier 96E 、Gentier 96R
Tianlong Technology Co., Ltd.
Gentier 48E、Gentier 48R

Validation of Instrument Compatiblility

It is recommended to do the LOD test to evaluate the compatiblility of the instrument. If the tested instrument is
near or slightly higher than the LOD of our kit, we think the instrument is compatible for our kit.
Sometimes the LOD test may not pass when using the PCR program according our kit’s instruction. In this case,
we recommend adjusting the PCR program to test again.
If the LOD test fails after adjusting the PCR procedure, we do not recommend using this instrument for
SARS-Cov-2 detection.
If you have any confusion, you can also consult our technicians.

www.cwbiosciences.com info@cwbiotech.com
江苏康为世纪生物科技股份有限公司