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Basic Info.
Model NO.
EC-HIV Ag/Ab 4th
Warranty
3 Years
Material
Medical Grade ABS Plastic
Package
Bottle + Carton
Function
Early Detection
Display
Screening
Format
Strip+Bottle
Name
HIV AG/Ab 4th Test Kit
Equipment
by Eye or Machine
Reaction Time
5-10 Seconds
Accuracy
99.7%
Delivery Time
3-5 Days
Temperature
4-30 Degree
Storage
Room Temperature
Transport Package
Carton
Specification
64*50*44 cm
Trademark
evancare or OEM
Origin
China
HS Code
3002150090
Production Capacity
100000PCS/Day
Product Description
EVANCARE Diagnostic HIV Antigen and HIV 1/2 Antibody Rapid Test
For professional and in vitro diagnostic use only.
For professional and in vitro diagnostic use only.
[INTENDED USE]
The reagent is used to detect HIV-1 p24 antigen (Ag) and antibodies (Ab) to
HIV-1 and HIV-2 in human serum / plasma / whole blood qualitatively.
Human immunodeficiency virus, also known as HIV. AIDS refers to the
destruction of the body's immune system by HIV, which causes the body to
lose its resistance to various pathogens that threaten life, resulting in a variety
of infections or tumors, leading to a serious infectious disease. It is mainly
transmitted through blood, sexual contact, and mother-to-child transmission.
[PRINCIPLE]
The reagent uses the principle of sandwich immunoassay to detect HIV
Antigen and HIV 1/2 antibodies. The reagent test line (T1) is coated with SA,
the reagent test line (T2) is coated with HIV-1 antigen and HIV-2 antigen ,the
quality control line (C) is coated with goat anti-rabbit IgG antibody.
When the sample contains HIV-1 P24 antigen and the concentration is equal
to or higher than the minimum detection limit, the antigen binds to the
biotinylated anti-p24 antibody from the sample pad and the gold colloid
anti-p24 antibody and forms an "antigen-bioinylated anti-P24 antibody-gold
colloid anti-P24 antibody complex".The complex moves forward, it is captured
by the SA pre-coated on the test line (T1) on the nitrocellulose membrane,
forming a reaction line,and the result is positive ,when the sample does not
contain HIV-1 P24 antigen or the concentration is lower than the minimum
detection limit, the test line (T1) does not appear, and the result is negative.
When the sample contains HIV1/2 antibodies and the concentration is equal
to or higher than the minimum detection limit, the antibody will form an
"antibody-gold-labeled antigen complex" with the labeled HIV1+2 antigen,
and move forward, it is captured by the HIV-1+2 mixed antigen pre-coated on
the test line (T2) on the nitrocellulose membrane, forming a reaction line,and
the result is positive ,when the sample does not contain HIV1/2 antibodies or
the concentration is lower than the minimum detection limit, the test line (T2)
does not appear, and the result is negative. Regardless of whether the sample
contains HIV-1 P24 antigen and HIV1/2 antibodies, the labeled rabbit IgG will
be captured by the goat anti-rabbit IgG antibody coated on the nitrocellulose
membrane, that is, the quality control line (C) will form a reaction line.
.
Positive: *Two lines appear. One colored line should be in the control
region (C), and another apparent colored line adjacent should be in the test
region (T).
Negative: One colored line appears in the control region (C). No line
appears in the test region (T).
Invalid: Control line fails to appear. Insufficient specimen volume or
incorrect procedural techniques are the most likely reasons for control line
failure. Review the procedure and repeat the test using a new test cassette.
If the problem persists, discontinue using the lot immediately and contact
your local distributor.
| Item No. | EVANCARE Diagnostic HIV Antigen and HIV 1/2 Antibody Rapid Test |
| Contents |
Each bag:1 test cassette and 1 desiccant(cassette)
We can put instruction as your requirement |
| Format / Size |
Cassette:2.5mm 3.0mm 4.0mm
|
| Methodology | Sandwich Colloidal Gold |
| Assay Type | Qualitative Detection |
| Specimen | Antibody (S/P/WB), |
| Indicator | HIV Antigen and HIV 1/2 Antibody test Cassette |
| Storage Temperature | 4-30 degree centigrade |
| Expiry date | 3 years |
| Certificate | CE,ISO,FREE SALE,FDA... |
| Detection Limits | Home or Professional Use
|
| Accuracy | > 99.99% |
| Reaction Time | 3-5 min |
| Delivery | 5-7 days |
| OEM Service | Available |
| Shipping Method | by air or sea or international express |
