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Human Immunodeficiency Virus HIV 1/2 Rapid Test Kit Cassette Format 24 Months Shelf Life

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO
Model Number: HIV-DW02
Minimum Order Quantity: 5000 units
Price: Negotiable
Packaging Details: 25test/box, 40test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Detail Information
Sample: Whole Blood/Serum/Plasma Type: Cassette
Certificate: ISO Origin: China
Shelf Life: 24 Months Usage: Professional Use
Highlight:

Cassette Format Rapid Test Kit

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HIV 1/2 Rapid Test Kit

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Human Immunodeficiency Virus Rapid Test Kit


Product Description

Human Immunodeficiency Virus (HIV 1/2) Rapid Test Diagnostic Test Kit

 

 
【INTENDED USE】
The HIV 1/2 Rapid Test (Whole Blood /Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of antibodies to HIV- 1/HIV-2 in human Whole Blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of HIV infection.
 
 
 
【INTRODUCTION】
HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV-1 and HIV-2 elicit immune response. Detection of HIV antibodies in serum, plasma or whole blood is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV. Despite differences in their biological characters, serological activities and genome sequences, HIV-1 and HIV-2 show strong antigenic cross-reactivity. Most HIV-2 positive sera can be identified by using HIV-1 based serological tests.
 
 
 
【PRINCIPLE】
The HIV 1/2 Rapid Test (Whole Blood/Serum/Plasma) detects antibodies to HIV-1/HIV-2 through visual interpretation of color development on the internal strip. Recombinant HIV antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with HIV antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient HIV-1/HIV-2 antibodies in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

 

 

 
【CONTENTS】
• Rapid test cassette with desiccant.
• Buffer
• Disposable pipettes
• Package insert
 
 
 
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
 
 
【SAMPLE COLLECTION AND STORAGE】
• The HIV 1/2 Rapid 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.
 
 
 
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after the expiration date indicated on the package. Do not use the test if the 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 completely guarantee the absence of transmissible pathogenic agents. It is therefore recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., 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 testing.
• 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 standard procedures for the proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded according to local regulations.
 
 
 
【OPERATION】
Bring tests, specimens, 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 test with patient or control identification. For best results, the assay should be performed within one hour.
2.Using the provided disposable pipette, transfer 2 drops of serum/Plasma to the specimen well (S) of the cassette with the provided disposable pipette, then start the timer.
OR
Transfer 1 drop of whole blood specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and start the timer.
OR
Allow 2 hanging drops of fingerstick whole blood specimen to fall into the center of the specimen well (S) on the cassette, 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 area.
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
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
 
 
 

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

 

 

 

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +8615267039708