Labnovation Technologies, Inc.
| Payment Terms | D/A, D/P, T/T |
| Supply Ability | 500000/Day |
| Delivery Time | 5-7 work day |
| Packaging Details | Carton |
| Storage | 2℃-30℃ |
| Humidity | ≤60% |
| Specimen | Serum, Plasma, Whole Blood |
| Application | Universal |
| Classification | IVD Test Kit |
| Fomat | Cassette |
| Brand Name | LABNOVATION |
| Model Number | LX-401201 |
| Certification | ISO13485, ISO9001, CE |
| Place of Origin | China |
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Product Specification
| Payment Terms | D/A, D/P, T/T | Supply Ability | 500000/Day |
| Delivery Time | 5-7 work day | Packaging Details | Carton |
| Storage | 2℃-30℃ | Humidity | ≤60% |
| Specimen | Serum, Plasma, Whole Blood | Application | Universal |
| Classification | IVD Test Kit | Fomat | Cassette |
| Brand Name | LABNOVATION | Model Number | LX-401201 |
| Certification | ISO13485, ISO9001, CE | Place of Origin | China |
| High Light | 20PCS Antibody Rapid Test Kit ，Antibody Rapid Test Kit Immunochromatography ，ODM at home antibody test kit | ||
Rapid Test Kit SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit 20 Tests For Professional Use Rapid Test Kit
Intended Use
The kit is a rapid test intended for the qualitative detection of the IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or whole blood sample from patients suspected of COVID-19 infection for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. Results from this test kit should not be used as the sole basis for diagnosis.
Specification
| Name | SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit |
| Number | LX-401201 |
| Sample Type | Serum/Plasma/Whole Blood |
| Products Shelf Life | 24 Months |
| Test Speed | <15 minutes |
| Sample Volume | 1 Drop(20ul) |
| Sample Type | serum / plasma / whole blood |
| Package | 20 Tests/Box |
| Storage Condition | 2℃-30℃ |
| Sensitivity | >90% |
| Specificity | >90% |
| Total Accuracy | >90% |
TEST PRINCIPLE
This kit is an immunochromatography assay, using capture method for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG antibody in human serum, plasma or whole blood sample. When the sample contains the SARS-CoV-2 IgM antibody, it forms a complex with the gold label antigen (SARS-CoV-2 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibody (Mouse anti-human IgM monoclonal antibody) at the IgM line to form a complex and develop color, which is a positive result. When the sample does not contain the SARS-CoV-2 IgM antibody, no complex can be formed and no red band appears in IgM line, which is a negative result.
Main Components
Product Feature
Use Step
For Serum/Plasma
1. Remove the test device from the sealed pouch, place it on a clean and level surface with the sample well up.
2. Add serum or plasma (10µl) vertically into the sample well .
3. Add two (2) drops (80-100µl) of sample buffer into the sample well .
4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.
For Whole Blood
1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.
2. Add whole blood (20µl) vertically into the sample well .
3. Add two (2) drops (80-100µl) of sample buffer into the sample well .
4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.
Interpretation of result
Advantage
Company Details
Business Type:
Manufacturer
Year Established:
2001
Total Annual:
10000000-50000000
Employee Number:
100~600
Ecer Certification：
Active Member
Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagent... Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagent...
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