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TUV Coronavirus Rapid Test Cassette

China Newscen Biopharm Co., Limited certification
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TUV Coronavirus Rapid Test Cassette

TUV Coronavirus Rapid Test Cassette
TUV Coronavirus Rapid Test Cassette TUV Coronavirus Rapid Test Cassette TUV Coronavirus Rapid Test Cassette TUV Coronavirus Rapid Test Cassette

Large Image :  TUV Coronavirus Rapid Test Cassette

Product Details:
Place of Origin: China
Brand Name: Sansure
Certification: ISO9001, CE, TUV, FDA
Model Number: S3102E
Payment & Shipping Terms:
Minimum Order Quantity: 10 Boxes or 240 Kits (24 Kits/Box)
Price: Negotiable as per Order Quantity
Packaging Details: 24 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton,
Delivery Time: 8 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 50,000 Kits Per Day
Detailed Product Description
High Light:

IgG IgM Coronavirus Test Kit

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TUV Coronavirus Rapid Test Cassette

Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit

 

(PCR-Fluorescence Probing)

 

Intended Use

 

Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit(PCR-Fluorescence Probing) is used for qualitative detection of the ORF1ab and N genes of novel coronavirus(2019-nCoV) in nasopharyngeal swab, oropharyngeal swab, alveolar lavage fluid, sputum, serum, whole blood and feces from suspected pneumonia cases with novel coronavirus infection, patients with suspected clusters of novel coronavirus infection, and other patients requiring diagnosis or differential diagnosis of novel coronavirus infection.

 

For in vitro diagnostic use only. For professional use only.

 

TUV Coronavirus Rapid Test Cassette 0

 

Test Principle

 

By applying Real-time fluorescence quantitative RT-PCR technology on the fluorescence quantitative PCR instrument, this test utilizes the novel coronavirus(2019-nCoV) ORF1ab and the specific conserved sequence of coding nucleocapsid protein N gene as the target regions which are designed for the conserved sequence of the double-target genes, to achieve detection of sample RNA through fluorescent signal changes.

 

The PCR detection system uses the positive internal control, which monitors the presence of PCR inhibitors in test specimens by detecting whether the internal control signal is normal, to avoid a false negative result.

 

Components of the Diagnostic Kit

 

This kit is an amplification reaction reagent and contains the following components:

 

No. Reagent Name Spec. & Qty Main Ingredients
24 T 48 T
1 2019-nCov-PCR Mix 624µL/tube x 1 1248µL/tube x 1 Premiers (4.62%), Probes (1.15%), dNTPs (3.85%), MgCl2 (0.77%), Rnasin (0.48%), PCR Buffer(89.13%)
2 2019-nCov-PCR-Enzyme Mix 96µL/tube x 1 192µL/tube x 1

RT Enzyme (62.5%),

Taq Enzyme (37.5%)

3 2019-nCov-PCR-Positive Control 500µL/tube x 1 500µL/tube x 1 In Vitro Transcriptional RNA Containing Target Genes (ORF1 ab, N gene) and internal standard gene fragments (Rnase P)
4 2019-nCov-PCR-Negative Control 500µL/tube x 1 500µL/tube x 1 Normal Saline

 

TUV Coronavirus Rapid Test Cassette 1

 

Test Method

 

Preparation of reagent (performed at “reagent preparation region”)

 

Take out each component from the diagnostic kit and place them at room temperature. Allow the reagents to equilibrate at room temperature, then vortex each of them respectively for later use.

 

According to the quantity of test specimens, 2019-nCoV-PCR-Positive Control and 2019-nCoV-PCR-Negative Control, pipette appropriate quantity of 2019-nCoV-PCR Mix and 2019-nCoV-PCR-Enzyme Mix (2019-nCoV-PCR Mix 26μL/test + 2019-nCoV- PCR-Enzyme Mix 4μL/test), mix them thoroughly to make a PCR-Mastermix, centrifuge it instantaneously for later use.

 

Item 1 sample 10 samples 24 samples 48 samples
2019-nCoV-PCR Mix (μL) 26 260 624 1248
2019-nCoV-PCR-Enzyme Mix (μL) 4 40 96 192
Note: The above configuration is just for your reference and to ensure enough volume of the PCR-Mastermix, more volume of the actual pipetting may be required.

 

Transfer the above-prepared reagents to the “specimen processing region” for later use.

 

PCR Amplification (Refer to user manual of each instrument to adjust the settings.)

 

Place PCR reaction tubes into the specimen wells of the amplification equipment. Set up the 2019-nCoV-PCR-Positive Control, 2019-nCoV-PCR-Negative Control and specimens to be tested in the corresponding sequence and input specimen name.

 

Select PCR Test Channel:

 

a. Select FAM (ORF-1ab region) and ROX (N gene) channels to test 2019-nCoV nucleic acid.

b. Select HEX channel to test internal control.

 

Set Cycle Parameters

 

No. Steps Temperature Time Cycle No.
1 Reverse transcription 50°C 30 min. 1
2 cDNA predenaturation 95°C 1 min. 1
3 Denaturation 95°C 15 sec. 45
Annealing, extension and fluorescence collection 60°C 30 sec.*
4 Device cooling 25°C 10 sec. 1

 

When the settings are completed, save the settings and carry out the reaction procedure.

 

Result Analysis (Refer to user manual of instrument to adjust the settings.)

 

Results will be saved automatically when reactions are completed. Analyze amplification curve of target of detection and internal control. Adjust Start, End and Threshold values of Baseline of the graph according to analysis result (Users can adjust the values according to the actual situation. Start value can be set between 3-15, and End value between 5-20. Adjust the amplification curve of negative control to be flat or below threshold). Click “Analyze” to implement the analysis, make sure each parameter satisfy the requirements given in “5. Quality Control”. Go to “Plate” window to record qualitative results.

 

Quality Control

 

Item 2019-nCoV-PCR-Negative Control 2019-nCoV-PCR-Positive Control
CT value

No Ct or Ct > 40 at channel FAM, ROX and HEX

(Internal Control)

≤ 35 at channel FAM, ROX and HEX

(Internal Control)

 

 

 

 

 

 

 

The test result is treated as valid if all the conditions in the above-mentioned are met for the same test. Otherwise the test result is treated as invalid and needs to be re-tested.

 

Reference Range

 

Through the research on reference values, the Ct reference value of target gene is determined to be 40, the CT reference value of internal control is determined to be 40.

 

Explanation of Detection Result

 

Conclusion Amplification results
2019-nCoV Positive There is typical S-shape amplification curve detected at FAM and/or ROX channel, and the amplification curve which is detected at HEX channel, Ct≤40.
2019-nCoV Negative There is no typical S-shape amplification curve(No Ct) or Ct > 40 detected at FAM and ROX channel, and the amplification curve which is detected at HEX channel, Ct ≤ 40.

 

There is no typical S-shape amplification curve detected at FAM, ROX and HEX channel (No Ct), or Ct > 40. It is indicated that the specimen’s concentration is too low, or there are interfering substances that inhibit the reaction. The test result is invalid. An investigation should be performed to find out and exclude the reasons, please collect specimen again and retest the specimens.

Note: For virus cultures, there is no requirements for internal control test results.

 

TUV Coronavirus Rapid Test Cassette 2

 

Product Performance Index

 

Accuracy

Test enterprise positive reference, the results are all positive.

 

Specificity

 

For Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing), there are also no cross-reaction with coronavirus (NL63, HKU1, 229E,OC43), SARS coronavirus, MERS coronavirus, influenza A virus, influenza B virus Type Yamagata and Type Victoria, influenza A (H1N1) virus, influenza A (H3N2) virus, influenza A (H5N1) virus, influenza A (H7N9) virus, respiratory syncytial virus type A and Type B, nasal virus Type A, Type B and Type C, adenovirus Type 1, 2, 3, 4, 5, 7 and 55, parainfluenza virus Type 1, 2 and 3, intestinal virus type A, type B, type C (EV-C95), type D(EV-D70), partial pulmonary virus, human lung virus, cryptococcus neoformans, pyogenic streptococcus, acinetobacter baumannii, pneumocystis carinii, klebsiella pneumoniae, streptococcus pneumoniae, haemophilus influenzae, pseudomonas aeruginosa, legionella pneumophilia, bordetella pertussis, staphylococcus aureus, mycoplasma pneumoniae pneumonia, streptococcus pneumoniae, klebsiella pneumoniae, chlamydia, EB virus, human cytomegalo virus, aspergillus fumigatus, candida albicans, candida glabrata, mycobacterium tuberculosis, non-tuberculous mycobacterium, norovirus, rotavirus, varicella zoster virus, measles virus, mumps virus, human genome DNA etc. positive samples. Test the enterprise negative reference, the result are all negative.

 

TUV Coronavirus Rapid Test Cassette 3

 

Precision:

 

The coefficient of variation (CV%) of CT value of the within-run precision is ≤5%.

 

Clinical evaluation is based on the recommend method of "Novel Coronavirus Infection Pneumonia Laboratory Testing Technology Guide”, “Novel Coronavirus Infection Pneumonia Cases Monitoring Programme (second edition)" to diagnosis/exclusion result as a comparision, in the Military Cademy of Military Medical Research Institute, Hunan Disease Control and Prevention Center, Hunan Province People's Hospital, Central South University Xiangya 2nd hospital, according to clinical data collected from the four institutions, such as statistical analysis, the preliminary evaluation, basic clinical confirmed the product performance can meet the emergency needs. The types of samples for clinical evaluation included pharyngeal swabs and alveolar lavage. Further clinical data will be collected after marketing to confirm the clinical performance of the product.

 

Due to the characteristics of swab and other sample collection process and viral infection process itself, false negative results may be caused by insufficient sample volume, which should be combined with other clinical diagnosis and treatment information for comprehensive judgment, retest when necessary.

 

Storage and Stability

 

The diagnostic kit should be stored in a sealed pouch at-20±5°C and protected from light. The kit is provisionally valid for 6 months.

Please refer to the date of manufacture and expiry date on the outer package.

The reagents keep valid and stable within the expiry date if not used. As long as the container of the reagent is opened, the freeze/thaw cycles should not exceed three.

 

Compatible Instrument

 

The diagnostic kit is applicable to SLAN-96P, ABI7500, Life Technologies QuantStudio TM5 , Roche Cobas480, MA-6000 PCR instrument.

 

TUV Coronavirus Rapid Test Cassette 4

 

TUV Coronavirus Rapid Test Cassette 5

Contact Details
Newscen Biopharm Co., Limited

Contact Person: Mr. Randy.Zhang

Tel: 008618611273771

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