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

Name: CE Approved Combo Respiratory Viral SARSCoV2 Influenza A B Virus PCR Test Freeze Dried Powder
Brand: Biokey
Price: 1 USD

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

Categories	Respiratory PCR Test
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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Guangzhou BioKey Healthy Technology Co.Ltd

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

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
3	40	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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