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New Product 20Pcs Covid-19 Igg/Igm Coronavirus Rapid Test Cassette High Accuracy Covid-19 Rapid Test Kit Novel Corona Virus Diagnostic Kit

This product is used for in vitro qualitative detection of 2019-ncov (COVID-19) IgG/IgM antibodies in human whole blood, plasma and serum samples
Item Code: TOPSFY13
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SFY13
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  • Description
Specifications
This product is suitable for the auxiliary diagnosis of 2019-ncov (COVID-19) infection.2019-ncov (COVID-19), mainly transmitted by inhalation and direct contact, is one of the main pathogens causing upper respiratory tract infection and lung diseases.It can cause the changes of the extrapulmonary system, which has aroused great concern. Timely and effective laboratory diagnosis of 2019-ncov (COVID-19) infection becomes particularly important
 
 
Feature:
This reagent uses immunochromatographic colloidal gold technique to detect 2019-ncov (COVID-19) IgG/IgM antibodies in samples.The detection card contains:
1) Recombinant COVID Antigen labeled colloidal gold
  1. Cellulose Membrane fixed with three lines (G line and M line) and one quality control line (C line) .The M line was coated with mouse anti-human IgM antibody for detection of 2019-ncov (COVID-19) IGM antibody .The G line was coated with mouse anti-human IgG antibody for detection of 2019-ncov (COVID-19) IgM antibody. The C line was coated with sheep anti-chicken antibody. When specimen is added to sample well, capillary effect causes the fluid to flow to the NC membrane, COVID IgM (if present) will bind with mouse anti-human IgM and the M line will be visible., COVID IgG (if present) will bind with mouse anti-human IgG and the G line will be visible. No matter whether the specimen is positive or negative, the C line should be visible, otherwise the test is invalid.
 
STORAGE AND STABILITY
The kit can be stored at cool ,dark place. (4-30°C). Valid for 24 months.
After opening the inner package, the detection reagent will lose its efficacy due to moisture absorption and should be used within 30 minutes.
 
SPECIMEN REQUIRMENTS
1.Can be used to detect whole blood, plasma and serum specimen.
2. Specimen were collected as general manner.
3. The Specimen which need to be test within 5 days can be stored at 4, and if the plasma and serum specimen which need to be test more than 5days should be frozen at -20.The test kit should be carried out freeze-thaw in -20 no more than 6 times .Do not freeze and thaw samples repeatedly.
4. Whole blood, plasma and serum shall be collected and stored in sterile conditions .Avoid sample hemolysis ,Samples contaminated with bacteria cannot be used for testing.

TEST METHOD
  1. In the early stage of infection, no IgG/IgM is produced or the titer is very low, which will lead to negative results. The patient should be prompted to review within 7-14 days.
  2. In patients with impaired immune function or receiving immunosuppressive therapy, serological antibody detection is of limited reference value.
  3. IgG/IgM antibody positivity occurs not only in primary infection but also in secondary infection.

PRODUCT PERFORMANCE
The performance of the product was tested with the enterprise new coronavirus-igg /IgM antibody for Internal control blood test, meeting the following requirements:
  1. egative reference product compliance rate: 10 negative serums in the internal control blood liquidation were tested, and the compliance rate was 10/10.
  2. Positive reference product Compliance rate: 10 positive serums in the internal control blood liquidation were tested, and the compliance rate was 10/10.
  3. Minimum detection amount: the minimum detection amount of serum in the internal control blood liquidation test, L1 should be negative, L2 and L3 should be positive.
  4. Precision: 10 detection reagents were tested in parallel with the precision serum of internal controlled blood liquidation, and the detection results were consistent and the chroma was uniform.
  5. Stability: after being placed at 37 for 14 days, the test should meet the above requirements.
  6. Cross reaction: with mycoplasma pneumoniae (MP) - IgM, chlamydia pneumonia (CP) - IgM, syncytial virus (RSV), influenza virus that the IgM (FluV) and mycobacterium tuberculosis (TB), hepatitis c virus (HCV), syphilis antibodies (TP), hepatitis b surface antigen (HBsAg), the AIDS virus (HIV), rheumatoid factor (RF) and antinuclear antibody (ANA) positive samples basic no cross reaction.
  7. Interference: there was no interference when compared with the samples containing 15mg/mL triglyceride, 6mg/mL hemoglobin and 0.2mg/mL bilirubin, respectively.

WARNINGS AND PRECAUTIONS
  1. ease operate in strict accordance with this instruction and strictly control the reaction time.
  2. This kit is a disposable product, which is only used for external diagnosis.The test results should be judged synthetically with other test indexes and medical characteristics.
  3. The test of samples must be carried out in a specific environment. The blood samples in contact during the test should follow the laboratory test procedures for infectious diseases.
  4. The small cup containing the serum must be clean and not reusable to avoid contamination.Test samples should be avoided from repeated freeze-thaw, and samples contaminated with bacteria should not be used for testing, so as not to affect the test results.Samples stored at 4 must be balanced to room temperature before use.
  5. Guard against moisture in the test strip. Use the test kit within 30 minutes after opening the inner package.
 
Specifications:
  • Silica Gel
  • Color: As shown.
  • Specimen Diluent5ML
 Package Lists:
20Pcs /Bag Covid-19 Igg/Igm Coronavirus Rapid Test

 
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About Us

Meida Technologies, LLC. is an international company with a hometown feel. We integrate women's fashion, toys &hobbies, outdoor sport, home & kitchen, pet supplies, these categories into one. We handle our customer service, marketing, order processing, returns, and sales. We ship from all over the world. Our extensive network and partnerships provide our customers with affordable and advanced products at a fraction of the cost.