The most developed technology platform with a variety of applications, including infectious disease detection, fertility detection, the drug of abuse detection, etc.
50+ kinds of reagents and three high-performance devices, focusing on detecting cardiovascular disease, inflammation, kidney injury, sex hormones, thyroid function, diabetes, tumor, and others.
Ready-to-use lyophilized RT-PCR Reagent；
Gold Standard for COVID-19 Diagnosis
Our blood gas analyzer can produce the result in 30s. Its advantages of portability, easy operation, durability, and high performance make it ideal for clinics, laboratories, and hospitals.
Wondfo optical blood coagulation analyzer is the only one in the world that can test PT, APTT, TT, FIB, and ACT simultaneously.
Wondfo Dry Chemistry Analyzer can test 16 items and provide the result within 2 minutes, ideal for the detection of cardiac markers, kidney function, liver function, pancreatitis, etc.
Target genes are ORF1ab and N, designed in accordance with the diagnosis and treatment guideline issued by the National Health Commission.
Benefits
Flexible Reagents
Open system reagents, applicable for major PCR detection system
Multiple Sample Types
Applicable to lower respiratory tract sample (sputum) and swabs
Lower Transport Cost
Lyophilized reagents, stable at 10-30℃ for 12 months
Whole Process Control
Internal whole-proess quality monitoring, from extraction, amplification to detection
Multiple Target Genes
Precisely targeting ORF1ab and N gene of 2019-nCoV
STORAGE AND STABILITY
1. Store at 10～30℃ in the sealed pouch up to the expiration date printed on the package. The validity period of this product is tentatively 12 months. It can be transported at 10～30℃.
2. Keep away from sunlight, moisture and heat.
3. Kit contents are stable until the expiration date printed on the outer box.
4. RT-PCR Lyophilized reagent should be used within 9 days after taking out from the sealed pouches, and the redissovled IC should be used within 9 days and stored at 2～8℃. Buffer solution should be re-capped in time after use.
INTENDED USE
Wondfo 2019-nCoV Real-Time RT-PCR Assay is a real-time reverse transcription PCR (RT-PCR) assay for rapid, qualitative detection of novel coronaviruses nucleic acid in oropharyngeal swabs, nasopharyngeal swabs and sputum specimens. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV.
The test provides preliminary test results. Negative results don’t preclude 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision.
For in vitro diagnostic use only. For professional use only.
SPECIFICATION
Description
Target Gene
ORF1ab, N gene
Time of Result
< 60min after extraction
Storage Condition
10-30℃
Specimen
Oropharyngeal swabs/Nasopharyngeal swabs/Sputum
Coincidence Rate
＞90%
Detection Limit
5.0x10*2 copies/mL
STANDARD OPERATION PROCEDURE
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