[Intended Usage]
This kit is used for the in vitro qualitative detection of suspected cases of pneumonia caused by New Coronavirus infection, patients with suspected clusters, other patients who need to be diagnosed or differentially diagnosed with the New Coronavirus infection, and nasopharyngeal swabs, oropharyngeal swabs, and bronchoalveolar lavage fluid samples of patients with mutation beads for the New Coronavirus ORF1ab and N gene, S gene N501Y mutation and S gene E484K mutation sites.
[Storage Conditions & Validity]
1. The kit should be stored frozen at -20 and protected from light; the expiration date is 6 months; the production date and expiration date are shown in the outer packaging box.
2. Avoid repeated freezing and thawing of the kit and the number of freezing and thawing shall not exceed 7 times.
3. After opening, the bottles should be stored at -20 and protected from light. The number of bottles opening times should not exceed 7 times, which will not affect the use within the validity period.
[Applicable Instruments]
1. This kit has been validated on ABI7500 quantitative fluorescence PCR instrument.
2. For other models not listed, relevant experiments have not been performed or completed for this kit. If users need to use this type of instrument platform to carry out the detection of this reagent, please contact our Technical Department at for relevant support.
NB: The other devices can include quantitative fluorescence PCR platforms with FAM, VIC, ROX and Cy5 channels.
[Sample Requirements]
1. Nasopharyngeal swabs, oropharyngeal swabs and other methods are used to obtain samples, and it is recommended to use commercial virus sampling kits for sample collection devices.
[Test Results Interpretation]
1. Negative and positive controls should be tested in each experiment and the test result can be determined only when the controls meet the quality control requirements.
2. When FAM, VIC and ROX channels are positive, Cy5 channel result may be negative due to the system competition.
3. When the internal standard result is negative, if the FAM, VIC and ROX signals of the test sample are also negative, the test result of the sample is invalid, and the cause should be found and eliminated, and the experiment repeated for this sample.
[Product Performance Index]
1. Precision: The coefficient of variation Intra-batch / Inter-batch, Intra-day / Inter-day among different operators shall not be higher than 5.0%.
2. Coincidence rate of negative positive controls: The coincidence rate of positive controls and negative controls is 100%.
3. Minimum detection limit: The minimum detection limit of this kit is 500 copies/mL.
[CE Mark Registration No.]: RPS/499/2021.
[EC REP.]: CMC MEDICAL DEVICES & DRUGS S.L. C/ Horacio Lengo n18, C.P 29006, Milaga, Spain.
- Can see the results in a short time 30 min. - More convenient than using blood. - Rapid production and supply are possible. - Convenient for personal use or at home. - Sensitivity 95% - Certified For EUROP And USA - Min order Discussed, Quote First - Fast delivery all Around the world By DHL FEDEX - In stock Korea by OTG. * Can supply Blood type Rapid test kit avail
Covid-19 Self Test Kit We are the authorized first vendor of ADTech! KFDA CE approved, FDA Pending Price : Negotiable Pre-Clinical Test Report Accuracy - In total samples 93.3% (14/15) - In positive samples 91.7% (11/12) 1. Pre-Clinical Test summary 1) Pre-clinical test is fulfilled by Domestic large clinical laboratory with ADTech COVID-19 IgM/IgG RAPID KIT 2) Tests are made by total 15 samples with 12 positive and 3 negative samples 3) Clinical Laboratory tested the sample with Immunofluorescence Analysis 2. Pre-clinical test result 1) Samples were tested by ADTech COVID-19 IgM/IgG RAPID KIT 2) Test result by ADTechs RAPID KIT - 4 negatives and 11 positives results in 15 samples 3) Comparison between Immunofluorescence analysis and ADTechs RAPID KIT - 14 test results are same(including negative and positive results) - 1 samples test result are different(Positive Negative by ADTech
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