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PCR TaqMan Respiratory Viral SARS CoV 2 Influenza A B Nucleic Acid Detection Test Kit

Categories Respiratory PCR Test
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 (PCR tube) 96 T/kit (carton)
Specimen type: Throat swab, nasal swab, nasopharyngeal swab, alveolar lavage fluid and sputum
Storage: -20±5℃
Applicable: Micgene 244/244 IVD(BIO-KEY)
LoD: 500 copies/mL
CV: ≤5%
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PCR TaqMan Respiratory Viral SARS CoV 2 Influenza A B Nucleic Acid Detection Test Kit

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 adopts 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.ComponentsAmount
1PCR Enzyme Mix (Lyophilized)96 tests/bottle
2Primer-Probe Mix 1 (SARS-CoV-2/Influenza A+B )50 μL/vial
3Primer-Probe Mix 2 (RSV/Adenovirus/M.pneumoniae)50 μL/vial
4Enzyme Mix Buffer (5×)400 μL/vial
5Positive Control100 μL/tube
6Negative Control100 μL/tube
7RNase-free water1mL/tube
8Paraffin oil1.5mL/tube*2

2. BIK-QL-H004S:

No.ComponentsAmount
11 (SARS-CoV-2/Influenza A+B Mix (Lyophilized))24 tests/kit
22 (RSV/Adenovirus/M.pneumoniae Mix (Lyophilized))24 tests/kit
3Positive Control100 μL/tube
4Negative Control100 μL/tube
5RNase-free water1mL/tube
6Paraffin oil1.5mL/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.


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.

Specimen requirements:


1. Specimen type

Throat swab, nasal swab, nasopharyngeal swab, alveolar lavage fluid and sputum.

2. Specimen preservation

The specimen can be stored for 3 months at -20±5℃ and for a long time below -70℃.


PCR amplification condition:

PCR amplification according to the following procedure:


StepCycle numberTemperatureTime
1150℃10min
2194℃3min
34094℃10s
60℃30s Collect the fluorescent
Select the detection channels as following:
Select FAM,VIC/HEX,ROX and CY5 channels

Interpretation of test results:


( 1)SARS-CoV-2/Influenza A+B reaction:

FAM

(SARS-CoV-2)

VIC/HEX

(Influenza A)

ROX

(Influenza B)

CY5

(IC)

Interpretation test results
1----Result invalid ,test again
2+--+/-SARS-CoV-2 (+)
3-+-+/-Influenza A(+)
4--++/-Influenza B(+)
5++-+/-SARS-CoV-2 ,Influenza A(+)
6+-++/-SARS-CoV-2 ,Influenza B(+)
7-+++/-Influenza A+B(+)
8++++/-SARS-CoV-2 ,Influenza A+B(+)
9---+Negative(-)

Operation details please check from IFU

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