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Multiplex Molecular Diagnosis Human Respiratory System Real Time PCR Kit Lyophilized

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Multiplex Molecular Diagnosis Human Respiratory System Real Time PCR Kit Lyophilized

Multiplex Molecular Diagnosis Human  Respiratory System Real Time PCR Kit Lyophilized
Multiplex Molecular Diagnosis Human  Respiratory System Real Time PCR Kit Lyophilized Multiplex Molecular Diagnosis Human  Respiratory System Real Time PCR Kit Lyophilized

Large Image :  Multiplex Molecular Diagnosis Human Respiratory System Real Time PCR Kit Lyophilized

Product Details:
Place of Origin: Guangzhou China
Brand Name: Biokey
Certification: ISO 13485,CE
Model Number: BIK-QL-H004 / BIK-QL-H004S
Payment & Shipping Terms:
Minimum Order Quantity: We can produce liquid and lyophilized kits
Price: USD
Packaging Details: Carton package
Delivery Time: Depending on order quantity
Payment Terms: L/C, T/T, Western Union
Supply Ability: 100,000 per day

Multiplex Molecular Diagnosis Human Respiratory System Real Time PCR Kit Lyophilized

Description
Package: 48 T/kit (single Tube) / 96 T/kit (carton) Expiration Date: 12 Months
Storage: -20±5℃ Applicable: Micgene 244/244 IVD(BIO-KEY)
Detection Limit: 500 Copies/mL CV: ≤5%
High Light:

Pcr Respiratory Test Kit RSV

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Multiplex Human Pcr Respiratory Test Kit

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RSV Real Time Pcr Kit Lyophilized

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.


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.


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:

 

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

 

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(-)

 

(2)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

Contact Details
Guangzhou BioKey Healthy Technology Co.Ltd

Contact Person: Ms. Lisa

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