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Professional Toxo IgG/IgM Rapid Diagnostic Test Kit for Whole Blood/Serum/Plasma Sample

Professional Toxo IgG/IgM Rapid Diagnostic Test Kit for Whole Blood/Serum/Plasma Sample
Professional Toxo IgG/IgM Rapid Diagnostic Test Kit for Whole Blood/Serum/Plasma Sample
Professional Toxo IgG/IgM Rapid Diagnostic Test Kit for Whole Blood/Serum/Plasma Sample Professional Toxo IgG/IgM Rapid Diagnostic Test Kit for Whole Blood/Serum/Plasma Sample Professional Toxo IgG/IgM Rapid Diagnostic Test Kit for Whole Blood/Serum/Plasma Sample Professional Toxo IgG/IgM Rapid Diagnostic Test Kit for Whole Blood/Serum/Plasma Sample
Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO
Model Number: TOX-DW22
Minimum Order Quantity: 3000 units
Price: Negotiable
Packaging Details: 40test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Get Best Price Contact Now
Detail Information
Sample: Whole Blood/Serum/Plasma Type: Cassette
Certificate: ISO Origin: China
Shelf Life: 24 Months Usage: Professional Use
Highlight:

Whole Blood Rapid Diagnostic Test Kit

,

Toxo IgG/IgM Diagnostic Test Kit

,

Plasma Rapid Diagnostic Test Kit

Product Description

Toxo IgG/IgM Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit

For professional use only.
For in vitro diagnostic use only.
 
 
 

【INTENDED USE】

The TOXO IgG/IgM Rapid Test Kit is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-Toxoplasma gondii in human whole blood, serum or plasma.

 

 

 

【INTRODUCTION】
This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with T. gondii. Any reactive specimen with the TOXO IgG/IgM Rapid Test Kit must be confirmed with alternative testing method(s) and clinical findings.
Toxoplasma gondii (T. gondii) is an obligate intracellular protozoan parasite with a worldwide distribution 1, 2 . Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism3 .
A variety of serological tests for antibodies to T. gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. These tests are: the SabinFeldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluo rescence and
ELISA4-7 . Recently, lateral flow chromatographic immune Rapid Test such as the Toxo IgG/IgM Cassette Rapid Test has been introduced to the clinic for the instant detection of T. gondii infection.
 
 
 
【PRINCIPLE】
The Toxo IgG/IgM Cassette Rapid Test is a lateral flow chromatographic immune Rapid Test. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant T. gondii antigens conjugated with colloidal gold (T. gondii conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (IgM and IgG bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for detection of IgM anti-T. gondii antibody, IgG band is pre-coated with reagents for detection of IgG anti-T. gondii antibody, and the C line is pre-coated with a control line antibody.
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. IgM anti-T. gondii if present in the specimen will bind to the T. gondii conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody forming a burgundy colored IgM line, indicating a T. gondii IgM positive or reactive test result.
IgG anti-T. gondii if present in the specimen will bind to the T. gondii conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane forming a burgundy colored IgG line, indicating a T. gondii IgG positive or reactive test result.
Absence of any T lines (IgM and IgG) suggests a negative or non-reactive result. The test contains an internal control (C band) which should exhibit a burgundy colored line of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless of color development on any of the T lines.
Otherwise, the test result is invalid and the specimen must be retested with another cassette.

 

 

 

【CONTENTS】
• Rapid Test.
• Buffer
• Disposable pipettes
• Instruction for use.
 
 
 
【PRECAUTIONS】
• Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to performing any tests.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Buffered Saline contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of buffered saline or extracted samples, always flush with copious quantities of water to prevent azide build up.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• The used testing materials should be discarded in accordance with local, state and/or federal regulations.
 
 

 

【STORAGE AND STABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
 
 

 

【SAMPLE COLLECTION】
• The Toxo IgG/IgM Test is intended for use with human whole blood, serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
 

 

 

【OPERATION】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma specimen to the specimen well (S) , then add 1 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.
As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

 

 

 
【INTERPRETATION OF RESULTS】
Negative (-) :
Only one color line appears on the control region (C).
Positive (+) :
IgG Positive: Both IgG test region (IgG) and control region appear color line.
IgM Positive: Both IgM test region (IgM) and control region appear color line.
IgG/IgM Positive: Both test region (IgG and IgM) and control region appear color line.
Invalid:
No visible line at all, or there is a visible line only in the test region and not in the control region. Repeat with a new test kit.
 
 
 
 

For further operation or performance details, please refer to final instruction manual.

 

 

 

 

Tag:

Rapid Test Kit,

POCT,

Rapid Diagnostic Test

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +8615267039708

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