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Zika IgG/IgM Infectious Disease Blood Tests 4mm Cassette Gold Colloidal CE Approval

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Zika IgG/IgM Infectious Disease Blood Tests 4mm Cassette Gold Colloidal CE Approval

China Zika IgG/IgM Infectious Disease Blood Tests 4mm Cassette Gold Colloidal CE Approval supplier

Large Image :  Zika IgG/IgM Infectious Disease Blood Tests 4mm Cassette Gold Colloidal CE Approval

Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Price: USD0.1-USD1
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 10000000pcs/month
Detailed Product Description
Category: Infectious Format: Cassette
Specimen: WB/S/Plasma Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: Zika IgG/IgM Test
Accuracy: 98.04%

Infectious Zika IgG/IgM Disease Blood Test, professional screen test use, 4mm cassette, gold colloidal method

 

 

 

Product Cat No Specimen Sensitivity Format Kit Size
Zika IgG/IgM YI182C4 Serum/Plasma See Insert 4mm Cassette 25T

 

Summary:

 

 

Zika fever (also known as Zika virus disease) is anillness caused by the Zika virus. Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever.Symptoms may include fever,red eyes,joint pain,headache, and a maculopapular rash. Symptoms generally last less than seven days. It has not caused any reported deaths during the initial infection. Infection during pregnancy causes microcephaly in some babies. Infections in adults has been linked to Guillain–Barré syndrome (GBS). Zika fever is mainly spread via the bite of mosquitoes of the Aedes type. It can also be sexually transmitted from a man to his sex partners and potentially spread by blood transfusions.Infections inpregnant women can be spread to the baby. The test is based on immunochromatography and can give a result within 15 minutes.

 

 

TEST PRINCIPLE

 

 

The Zika IgG/IgM Rapid Test is a qualitative membrane strip based immunoassay for the detection of Zika virus antibodies (IgG and IgM) in Whole Blood /Serum / Plasma.The test device consists of: 1) a burgundy colored conjugate pad containing Zika recombinant envelope antigens conjugated with Colloid gold (Zika conjugates), 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-Zika, T2 band is coated with antibody for the detection of IgG anti- Zika. When an adequate volume of test specimen is dispensed into the sample well of the test cassette,the specimen migrates by capillary action across the cassette. IgG anti- Zika, if present in the specimen, will bind to the Zika conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band,forming a burgundy colored T2 band, indicating a Zika IgG positive test result and suggesting a recent or repeat infection.IgM anti- Zika if present in the specimen will bind to the Zika conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a Zika IgM positive test result and suggesting a fresh infection.Absence of any T bands(T1 and T2) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

 

TEST PROCEDURE

 

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

 

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

 

INTERPRETATION OF RESULTS

 

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

 

Negative:

The control line appears in the result window, but the test line is not visible.

 

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

 

 

Zika IgG/IgM Infectious Disease Blood Tests 4mm Cassette Gold Colloidal CE Approval

 

Performance:

 

The Zika IgG/IgM Rapid Test cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of seroconversion panel and has been compared to a leading commercial ELISA Zika IgG test and Eliza Zika IgM test using clinical specimens.

 

The results show that the relative sensitivity of the Zika IgG Rapid Test cassette (Whole Blood/Serum/Plasma) is >97.14% , the relative specificity is 98.64% and an accuracy of 98.34%.

 

Method       ELISA Zika IgG  
            Total Result
  Results   Positive   Negative
       
Zika IgG            
Positive   34   3 37
(Whole Blood/Serum/Plasma)    
           
             
  Negative   1   217 218
             
Total Result     35   220 255
             
Relative Sensitivity: 97.14%          
Relatively Specificity: 98.64%.          
Accuracy:98.43%      

 

The results show that the relative sensitivity of the Zika IgM Rapid Test cassette (Whole Blood/Serum/Plasma) is >92.60% ,the relative specificity is 98.68% and an accuracy of 98.04%.

 

 

Method       ELISA Zika IgM  
            Total Result
  Results   Positive   Negative
       
Zika IgM            
Positive   25   3 28
(Whole Blood/Serum/Plasma)    
           
             
  Negative   2   225 2278
             
Total Result     27   228 255
             
Relative Sensitivity: 97.14%          
Relatively Specificity: 98.64%.          
Accuracy:98.43%      

 

 

 

 

Conclusion:

 

The sample correlation results show that the relative sensitivity of the Zika IgG Rapid Test cassette is 97.14%, and the relative specificity is 98.64% and the overall accuracy is 98.43% to be compared with a commercial available Zika IgG ELISA test.

 

 

The sample correlation results show that the relative sensitivity of the Zika IgM Rapid Test cassette is 92.60%, and the relative specificity is 98.68% and the overall accuracy is 98.04% to be compared with a commercial available Zika IgM ELISA SET.

 

 
ORIENT NEW LIFE MEDICAL CO., LTD.
Contact: Jerry Meng
Email: Jerry @ newlifebiotest .com
Tel. +86 18657312116
SKYPE enetjerry

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