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Human Respiratory Multiplex Viral DNA RNA detection RT qPCR Test Kit Lyophilized

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Human Respiratory Multiplex Viral DNA RNA detection RT qPCR Test Kit Lyophilized

Name: Human Respiratory Multiplex Viral DNA RNA detection RT qPCR Test Kit Lyophilized
Brand: Biokey
Price: 1 USD

Brand Name : Biokey

Model Number : BIK-QL-H004

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 : 96 tests/kit (carton)

expiration date : 12 months

Storage : -20±5℃

Applicable : Micgene 244/244 IVD(BIO-KEY)

Detection limit : 500 copies/mL

CV : ≤5%

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Multiplex fluorescent probe Humam Respiratory viral RT qPCR 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

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℃.

Data Analysis and interpretation:

The following sample results are possible::

	Ct value	Result Analysis
1#	No Ct	Negative
2#	≤38	Positive
3#	38~40	Re-test; if it is still 38~40, report as 2#

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

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