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Shenzhen Lvshiyuan Biotechnology Co., Ltd
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Shenzhen Lvshiyuan Biotechnology Co., Ltd

Guangdong,China

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Shenzhen Lvshiyuan Biotechnology Co., Ltd

Guangdong,China

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Shenzhen Lvshiyuan Biotechnology Co., Ltd

Guangdong,China

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SARS-CoV-2 Antigen Rapid Test Kit (Immunofluorescence Assay)

FOB Price : Get a Price/Quote

Min.Order : 40 Box(es)

Certification : CE

Brand Name : Green Spring

Payment Terms : T/T

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product information

  • brand name : Green Spring

  • certification : CE

  • min.order : 40 Box(es)

  • warranty : 12months

  • payment terms : T/T

  • Packaging : 25kits/box

  • Specification : 210*135*85mm

  • place of origin : China

product description

Component:
Component 25Tests/Kit Main component
Test device 25 Tests/Kit(1Test/bag ×25 Bags) The anti-nucleocapsid protein antibody labeled by fluorescent, the nitrocellulose membrane
coated with anti-nucleocapsid protein antibody and goat anti-mouse IgG antibody.
Desiccant 25 packs Silica Gel
Buffer 25 bottles, each with 0.5ml Detergent solution
Extraction tube 25 single-use reaction tubes, each with 1x nozzle cap
 		  
Specimen sampling swabs 25 sterile, single-use specimen sampling swabs
 		  
Package Insert 1 Instruction for Use  
Storage and Stability:
1.Store at 2~30ºC in the sealed pouch up to the expiration date and the validity is tentatively 12 months. Do not freeze.
2.The test cassette should be used within 1 hour after taking out from the aluminum foil bag.
3.Keep away from sunlight, moisture, and heat.
Test Procedure:
1.Tear off the foil pouch, take out the test strip/cassette and place the test kit on a clean and level surface.
2.Turn on the instrument according to the instruction.
3.Check the consistence of the ID chip and the batch number or the diagnostic kits. Insert ID Chip into GS-F1000 Fluorescent Immunoanalyzer and read the ID Chip.
4.Freshly collected specimens should be processed within 1hour.
5.Label one test device and one extraction tube for each specimen or control to be tested.
6.Place the labeled extraction tube(s) in a rack in the designated area of the workspace.
7.Twist off the top of the buffer bottle, dispense entire buffer into the extraction tube.
8.Insert the swab into the tube and plunge the swab up and down in the fluid for a minimum of 10 seconds, then hold the swab against the bottom of the tube and rotate 3 turns, taking care not to splash contents out of the tube.
9.Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
10. Press the nozzle cap firmly onto the extraction tube containing the processed sample (threading or twisting is not required). Mix thoroughly by swirling or flicking the bottom of the tube.
NOTE: Do not use tubes or tips from any other product, or from other manufacturers.
11. Gently squeeze the ridged body of the tube, dispensing three (3) drops of the processed specimen into the sample well.
12. Read the test results between 15 and 20 minutes by the GS-F1000 Fluorescent Immunoanalyzer. Do not read the results after 20minutes
Performance Characteristics:
1.Clinical Performance
The performance of the kit was established with 300 direct nasopharyngeal swabs prospectively collected and enrolled from individual symptomatic patients (within 5 days of onset) who were suspected of COVID-19. As with all antigen tests, performance may decrease as days since symptom onset. Samples were collected by qualified personnel in China.
Nasopharyngeal swabs were collected following the dual nares method and handled as described in this instruction. Specimens were frozen within 30 minutes of collection and stored until tested. All specimens within a pre-specified date range were selected and then sequentially tested in a blinded fashion.
The performance of the kit was compared to the results of a nasopharyngeal swab tested with a commercialized molecular assay.
The kit showed 99% of sensitivity (95% Cl: 97.12-99.98%) and 100% of specificity (95% Cl: 98.12-99.99%).
2.Assay Cross-Reactivity
Cross-Reactivity: There was no cross-reaction with potential cross-reactive substances except SARS-coronavirus.

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Shenzhen Lvshiyuan Biotechnology Co., Ltd

Ordinary verified

Business Type Manufacturer

Country / Region Guangdong,China

Main Products In vitro Diagnosis Reagents

Main Markets

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SARS-CoV-2 Antigen Rapid Test Kit (Immunofluorescence Assay)
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contact now

product information

product description

Component:
Component 25Tests/Kit Main component
Test device 25 Tests/Kit(1Test/bag ×25 Bags) The anti-nucleocapsid protein antibody labeled by fluorescent, the nitrocellulose membrane
coated with anti-nucleocapsid protein antibody and goat anti-mouse IgG antibody.
Desiccant 25 packs Silica Gel
Buffer 25 bottles, each with 0.5ml Detergent solution
Extraction tube 25 single-use reaction tubes, each with 1x nozzle cap
 		  
Specimen sampling swabs 25 sterile, single-use specimen sampling swabs
 		  
Package Insert 1 Instruction for Use  
Storage and Stability:
1.Store at 2~30ºC in the sealed pouch up to the expiration date and the validity is tentatively 12 months. Do not freeze.
2.The test cassette should be used within 1 hour after taking out from the aluminum foil bag.
3.Keep away from sunlight, moisture, and heat.
Test Procedure:
1.Tear off the foil pouch, take out the test strip/cassette and place the test kit on a clean and level surface.
2.Turn on the instrument according to the instruction.
3.Check the consistence of the ID chip and the batch number or the diagnostic kits. Insert ID Chip into GS-F1000 Fluorescent Immunoanalyzer and read the ID Chip.
4.Freshly collected specimens should be processed within 1hour.
5.Label one test device and one extraction tube for each specimen or control to be tested.
6.Place the labeled extraction tube(s) in a rack in the designated area of the workspace.
7.Twist off the top of the buffer bottle, dispense entire buffer into the extraction tube.
8.Insert the swab into the tube and plunge the swab up and down in the fluid for a minimum of 10 seconds, then hold the swab against the bottom of the tube and rotate 3 turns, taking care not to splash contents out of the tube.
9.Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
10. Press the nozzle cap firmly onto the extraction tube containing the processed sample (threading or twisting is not required). Mix thoroughly by swirling or flicking the bottom of the tube.
NOTE: Do not use tubes or tips from any other product, or from other manufacturers.
11. Gently squeeze the ridged body of the tube, dispensing three (3) drops of the processed specimen into the sample well.
12. Read the test results between 15 and 20 minutes by the GS-F1000 Fluorescent Immunoanalyzer. Do not read the results after 20minutes
Performance Characteristics:
1.Clinical Performance
The performance of the kit was established with 300 direct nasopharyngeal swabs prospectively collected and enrolled from individual symptomatic patients (within 5 days of onset) who were suspected of COVID-19. As with all antigen tests, performance may decrease as days since symptom onset. Samples were collected by qualified personnel in China.
Nasopharyngeal swabs were collected following the dual nares method and handled as described in this instruction. Specimens were frozen within 30 minutes of collection and stored until tested. All specimens within a pre-specified date range were selected and then sequentially tested in a blinded fashion.
The performance of the kit was compared to the results of a nasopharyngeal swab tested with a commercialized molecular assay.
The kit showed 99% of sensitivity (95% Cl: 97.12-99.98%) and 100% of specificity (95% Cl: 98.12-99.99%).
2.Assay Cross-Reactivity
Cross-Reactivity: There was no cross-reaction with potential cross-reactive substances except SARS-coronavirus.
Shenzhen Lvshiyuan Biotechnology Co., Ltd
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