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Rubella IgG/IgM Rapid Test Kit Professional with Whole Blood/Serum/Plasma Sample

Rubella IgG/IgM Rapid Test Kit Professional with Whole Blood/Serum/Plasma Sample
Rubella IgG/IgM Rapid Test Kit Professional with Whole Blood/Serum/Plasma Sample
Rubella IgG/IgM Rapid Test Kit Professional with Whole Blood/Serum/Plasma Sample Rubella IgG/IgM Rapid Test Kit Professional with Whole Blood/Serum/Plasma Sample Rubella IgG/IgM Rapid Test Kit Professional with Whole Blood/Serum/Plasma Sample Rubella IgG/IgM Rapid Test Kit Professional with Whole Blood/Serum/Plasma Sample
Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO
Model Number: RUB-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 Test Kit

,

Plasma Rapid Test Kit

,

Serum Rapid Test Kit

Product Description

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

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

【INTENDED USE】

Rubella IgG/IgM Rapid test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to Rubella virus in human serum plasma or whole blood. This test provides only a preliminary test result. Therefore, more specific alternative diagnosis method such as Sabin-Feldman dye test for IgG antibodies, the IgM-IFA (Immuno-fluorescent Antibody) test and the PCR test must be used in order to obtain a confirmation of Rubella infection.

 

 

【INTRODUCTION】
Rubella (commonly known as German measles or 3-day measles) is an infection that primarily affects the skin and lymph nodes. It is caused by the rubella virus (not the same virus that causes measles), which is usually transmitted by secretions from the nose or throat. It can also pass through a pregnant woman's bloodstream to infect her unborn child. As this is a generally mild disease in children, the primary medical danger of rubella is the infection of pregnant woman, which may cause congenital rubella syndrome in developing babies.
 
 
 
【PRINCIPLE】
Rubella IgG/IgM test device has 3 pre-coated lines, “IgG” (Rubella IgG Test Line), “IgM” (Rubella IgM Test Line) and “C” (Control Line) on the surface of the membrane. All three lines in result window are not visible before applying any samples. The “Control Line” is used for procedural control. Control line should always appear if the test procedure is performed properly and the test reagents of control line are working. A purple “IgG” and “IgM” lines will be visible in the result window if there are enough IgG and/or IgM antibodies to Rubella virus in the sample. If IgG and/or IgM antibodies to Rubella virus are not present in the sample, there is no color appearance in “IgG” and/or “IgM”.

 

 

 

【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 Rubella 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.
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.
2. 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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