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CE Approved Combo Respiratory Viral SARS-CoV-2 Influenza A B Virus PCR Test Freeze Dried Powder

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China CE Approved Combo Respiratory Viral SARS-CoV-2 Influenza A B Virus PCR Test Freeze Dried Powder wholesale
  • China CE Approved Combo Respiratory Viral SARS-CoV-2 Influenza A B Virus PCR Test Freeze Dried Powder wholesale
  • China CE Approved Combo Respiratory Viral SARS-CoV-2 Influenza A B Virus PCR Test Freeze Dried Powder wholesale

CE Approved Combo Respiratory Viral SARS-CoV-2 Influenza A B Virus PCR Test Freeze Dried Powder
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Brand Name :Biokey
Model Number :BIK-QL-H010 / BIK-QL-H010S
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
Specimen :Nasal / throat swab
expiration date :12 months
Logistic condition :Room temperature
Applicable :Micgene 244/244 IVD(BIO-KEY)
Limited of Detection :500 copies/mL
CV :≤5%
Component :RT-PCR Enzyme Mix, Primers and Probes
Packing :Freeze Dried powder lyophilization
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CE approved Combo Respiratory virus SARS-CoV-2 / Influenza A+B PCR Test Freeze Dried Powder


Intended use:

This kit is used for in vitro qualitative detection of SARS-CoV-2/Influenza A+B 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,
the primer probes, together with RT-PCR reaction solutionfor fluorescent detection are designed and labeled with different
fluorescent groups. On the fluorescence quantitative PCRinstrument, the real-time fluorescence quantitative PCR
detec tion technology is used to realize the rapid detection of SARS-CoV-2/Influenza A+B 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:

No Components BIK-QL-H010 BIK-QL-H010S
1

PCR Enzyme Mix

(Lyophilized)

 96 tests/bottle 48 tests/kit
2 Primer-Probe Mix 100 μL/vial /
3 Enzyme Mix Buffer (5×) 400 μL/vial /
4 Positive Control 100 μL/tube 100 μL/tube
5 Negative Control 100 μL/tube 100 μL/tube
6 RNase-free water 1mL/tube 1mL/tube
7 Paraffin oil 1.5mL/tube*2 1.5mL/tube
Note: Do not mix the components from different batches for
detection. The Positive Control of SARS-CoV-2/Influenza
A+B 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

Interpretation of test results:

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 ,Influ

enza A(+)
6 +

-

 + +/-

SARS-CoV-2 ,Influ

enza B(+)
7 - + + +/- Influenza A+B(+)
8 + + + +/-

SARS-CoV-2 ,Influ

enza A+B(+)
9 - - - + Negative(-)

NOTE: ‘+ ’ is positive, ‘- ’ is negative.


Operation details please check from IFU!

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