Specifications
Brand Name :
Biokey
Model Number :
BIK-QL-H004 / BIK-QL-H004S
Certification :
ISO 13485,CE
Place of Origin :
Guangzhou China
MOQ :
We can produce liquid and lyophilized kits
Price :
USD
Payment Terms :
L/C, T/T, Western Union
Supply Ability :
100,000 per day
Delivery Time :
Depending on order quantity
Packaging Details :
Carton package
Package :
48 T/kit(single pcr tube)
Specimen type :
Throat swab, nasal swab, nasopharyngeal swab, alveolar lavage fluid and sputum.
Specimen preservation :
stored for 3 months at -20±5℃ and for a long time below -70℃
Applicable :
Micgene 244/244 IVD(BIO-KEY)
LoD :
500 copies/mL
CV :
≤5%
Description

Multiplex Respiratory viral RT-PCR test kit Lyophilized


Intended use:

This kit is used for in vitro qualitative detection of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae from patients with respiratory tract infection. The test results are for clinical reference only, it cannot be used alone as the basis for the diagnosis or exclusion of cases

Test Principle:


The kit adopt TaqMan fluorescent probe method. For the highly conserved and specific region of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae, the primer probes, together with RT-PCR reaction solutionfor fluorescent detection are designed and labeled with different fluorescent groups. On the fluorescence quantitative PCR instrument, the real-time fluorescence quantitative PCR detection technology is used to realize the rapid detection of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae through the change of fluorescent signal.The detection system contains positive internal control, used to monitor whether the nucleic acid extraction process is normal.The kit adopt TaqMan fluorescent probe method. For the highly conserved and specific region of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae, the primer probes, together with RT-PCR reaction solutionfor fluorescent detection are designed and labeled with different fluorescent groups. On the fluorescence quantitative PCR instrument, the real-time fluorescence quantitative PCR detection technology is used to realize the rapid detection of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae through the change of fluorescent signal.The detection system contains positive internal control, used to monitor whether the nucleic acid extraction process is normal.

Biokey Multiple Respiratory PCR testing solution.p...


Product components:

1. BIK-QL-H004:

No. Components Amount
1 PCR Enzyme Mix (Lyophilized) 96 tests/bottle
2 Primer-Probe Mix 1 (SARS-CoV-2/Influenza A+B ) 50 μL/vial
3 Primer-Probe Mix 2 (RSV/Adenovirus/M.pneumoniae) 50 μL/vial
4 Enzyme Mix Buffer (5×) 400 μL/vial
5 Positive Control 100 μL/tube
6 Negative Control 100 μL/tube
7 RNase-free water 1mL/tube
8 Paraffin oil 1.5mL/tube*2

2. BIK-QL-H004S:

No. Components Amount
1 1 (SARS-CoV-2/Influenza A+B Mix (Lyophilized)) 24 tests/kit
2 2 (RSV/Adenovirus/M.pneumoniae Mix (Lyophilized)) 24 tests/kit
3 Positive Control 100 μL/tube
4 Negative Control 100 μL/tube
5 RNase-free water 1mL/tube
6 Paraffin oil 1.5mL/tube

Note: Do not mix the components from different batches for detection. The Positive Control of SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae and internal control were constructed artificially, and they were not infectious.

Multiplex Respiratory Syncytial Virus RSV Streptococcus Pneumoniae Adenovirus PCR TestMultiplex Respiratory Syncytial Virus RSV Streptococcus Pneumoniae Adenovirus PCR Test


Storage and stability:

1.The kit should be stored under -20±5℃ and protected from light. Its period of validity is 12 months. Products can be shipped at room temperature for 7 days.
2.Repeated thawing and freezing should be no more than 3 times.

PCR amplification condition:

PCR amplification according to the following procedure:

Step Cycle number Temperature Time
1 1 50℃ 10min
2 1 94℃ 3min
3 40 94℃ 10s
60℃ 30s Collect the fluorescent
Select the detection channels as following:
Select FAM,VIC/HEX,ROX and CY5 channels
Quality control:
Negative Control: None of the FAM, VIC/HEX, ROX & IC (CY5) channels have a Ct value or Ct > 40;
Positive Control: FAM, VIC/HEX, ROX & IC (CY5) channels Ct ≤ 30;
The above two items should be met simultaneously in one experiment. Otherwise, the experiment is invalid and should be repeated.

Interpretation of test results:

RSV/Adenovirus/M.pneumoniae reaction:

FAM

(RSV)

VIC/HEX

(Adenovirus)

ROX

(M.pneumonia)

CY5

(IC)

Interpretation test results
1 - - - - Result invalid ,test again
2 + - - +/- RSV(+)
3 - + - +/- Adenovirus(+)
4 - - + +/- M.pneumonia(+)
5 + + - +/- RSV,Adenovirus(+)
6 + - + +/- RSV,M.pneumonia(+)
7 - + + +/- Adenovirus, M.pneumonia (+)
8 + + + +/- RSV, Adenovirus, M.pneumonia(+)
9 - - - + Negative(-)


Operation details please check from IFU

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Multiplex Respiratory Syncytial Virus RSV Streptococcus Pneumoniae Adenovirus PCR Test

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Brand Name :
Biokey
Model Number :
BIK-QL-H004 / BIK-QL-H004S
Certification :
ISO 13485,CE
Place of Origin :
Guangzhou China
MOQ :
We can produce liquid and lyophilized kits
Price :
USD
Contact Supplier
Multiplex Respiratory Syncytial Virus RSV Streptococcus Pneumoniae Adenovirus PCR Test

Guangzhou BioKey Healthy Technology Co.Ltd

Verified Supplier
3 Years
guangzhou
Since 2003
Business Type :
Manufacturer, Distributor/Wholesaler, Exporter, Seller
Total Annual :
5M-10M
Employee Number :
100~200
Certification Level :
Verified Supplier
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