CE/FDA Approved Infectious Disease Rapid Antibody Test Kit

• Customization: Available
• Type: Diagbostic Kit
• Material: Plastic
• Model NO.: TSMDRTK01
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: One Year
• Group: All Persons
• Logo Printing: With Logo Printing
• Category: Diagnostic Consumables
• Single Use: Yes
• Sterile: Yes
• Operation: Simple and Rapid
• Sample: Available
• Delivery Time: 15-20 Days
• Accuracy: High
• Place of Use: Both Home and Hospital
• MOQ: 500 Sets
• Certificate: CE, ISO13485
• Transport Package: Packed in Box, Shipped by Sea, Air and Express
• Trademark: OEM or ODM
• Origin: China
• Production Capacity: 10000000000000sets/Year

Product Description

Infectious Disease Antibody Test Kit (colloidal gold immunochromatography)

Model
One test per bag for one person, 20 tests/kit

Intended Use
The product is intended for the qualitative detection of antibody content against Infectious Disease/virus in clinical samples (serum/plasma/whole blood).

Infectious virus, as a large virus family, is a single positive stranded RNA virus with envelope. The virus is known to cause major illnesses such as colds, Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome . The core protein of the virus is the N protein (nucleocapsid), which is a protein component located inside the virus. It is relatively conserved among β-coronaviruses and is often used as a tool for the diagnosis of coronaviruses. ACE2, as a key receptor to enter cells, is of great significance for the research of viral infection mechanism. 

The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled recombinant protein, mouse-anti human IgG antibody immobilized in T2 test area, mouse-anti human IgM antibody immobilized in T1 test area and the corresponding antibody in quality control area (C). 
During the test, when the IgM antibody level in the sample is at or above the limit of detection of the test, the IgM antibody in the sample binds to the colloidal gold recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in T1 test area subsequently and this produces a purple-red band appears in the T1 test area. When the IgG antibody level in the sample is at or above the limit of detection of the test, the IgG antibody in the sample binds to the colloidal gold recombinant protein which is pre-coated on a gold label pad. The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in T2 test area subsequently and this produces a purple-red band appears in the T2 test area. If it is a negative sample, there is not a purple-red band appeared in the T1 and T2 test area. Regardless of the presence or absence of the antibody in the sample, a purple-red band will appear in the quality control area (C). The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.

The product contains 20 tests, one IFU (instruction for use) and one lot number card. 
For each test, it contains one testing strip, one dropper and one package of desiccant.
The testing strip is composed of one gold standard mat (colloidal gold recombinant protein), sample mat, cellulose nitrate membrane (Mouse-anti human IgM antibody immobilized in T1 area, Mouse-anti human IgG antibody immobilized in T2 area; Goat anti-mouse antibody immobilized in C area), absorbing paper, plastic carrier board.


Storage and Stability
It should be stored at 4ºC~ 30ºC, be kept dry and away from sunlight. The shelf life is 12 months.
For per test strip, it should be used within 1 hour after unsealing.
Production Date and Expiration date are shown in the package label.

Sample Requirements
The test strip can be performed with serum/plasma/whole blood.
The blood should be collected by professional medical staff, and it is advised of detecting serum/plasma in priority, and under emergency conditions or special conditions, the whole blood of patients can be used for rapid testing.
After collection of samples, it should be tested immediately. It is forbidden for long time placement of the sample under room temperature. For whole blood sample, if it can not be tested in time, it can preserve for 24 hours between 2 and 8ºC. Serum/plasma samples can be preserved for 3 days under temperature between 2 and 8ºC, and for long time storage, they should be stored under -20ºC, and it should avoided repeated freeze-thaw cycles. 
Before testing, the sample must be restored to room temperature, ready for application only after homogeneity.
The sample must be returned to room temperature before testing, and should be used after mixing.
Do not use samples with severe hemolysis, severe lipids, and jaundice.

Test Method
Please read the instruction for use carefully before performing the test. Before testing, restore the reagents and blood sample to room temperature.
1. Remove the test strip from the packaging reagent bag and use it within 1 hour, especially in an environment with room temperature higher than 30 ° C or in high humidity.
2. Place the kit on a clean platform.
l Serum or plasma sample: Add 10 uL of serum or plasma sample to well A, and then add two drops (about 80 uL) of sample dilution to well B, and start timing.
l Whole blood sample: Add 20 uL of whole blood sample to sample well A, and then add two drops (about 80 uL) of sample dilution to sample well B, and start timing.

3. Wait for the fuchsia band to appear. The test results should be read within 10-20 minutes. Do not read the results after 20 minutes. 

The Explanation of the Testing Results
l Positive (+): There appear purple stripes in both quality control area and either area T1 or T2.
l Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in either test area T1 and test area T2.
l Invalid: There is no purple stripe in the quality control area (C), indicating incorrect operating procedures or the testing strip has already deteriorated. Under this conditions, it must read the instruction for use again carefully, and then use the new test strips to test again. If the problem still exists, stop using this lot number immediately and contact the local suppliers.

 
Limitation of Procedure
1. The test results of this product should be comprehensively judged by the physician in combination with other clinical information, and should not be used as the only criterion;
2. The product is used to test the respiratory virus antibody of the tested sample.

















Company profile


FAQ

Q1. What is the advantage about your company?
 A1.  We have more than 10 years' experience in medical industry. Our company has a professional team and production lines.

Q2. Why should I choose your products?
 A2. Our products with high quality and competitive price. We carry out doulbe QC for every order.

Q3. About MOQ?
A3. Usually is 10000 pieces. We would like to cooperate with you, no worries about MOQ, just send us your inquiry.

Q4. Is the logo can be customized?
A4. Yes, Logo customization is accepted.

Q5. What about the sample lead time?
A5. Normally, we keep most of the products in stock, we can ship samples out in 5-10 days.

Q6. What's your shipment method of the sample?
A6. We ship by FEDEX, UPS, DHL, EMS or Sea.