Dengue IgG/IgM Rapid Test Kit
(Colloidal Gold)
【Product Name】
Generic name: Dengue IgG/IgM Rapid Test Kit
(Colloidal Gold)
【Packing Specification】
25 tests/box
【Intended
Use】
This kit is applicable for in
vitro qualitative test of Dengue IgG/IgM antibody in the sample of human serum,
plasma and whole blood.
Clinically, this kit is mainly
applicable for auxiliary diagnosis of dengue fever.
【Test
Principle】
By the immunochromatographic technique, this kit tests the Dengue
IgG/IgM antibody through antibody capturing method. At the test, the treated
extract is dripped into sample injection hole of test card. When Dengue IgG/IgM
antibody exists in test sample and its concentration is higher than minimum
detection limit, Dengue IgG/IgM antibody first forms with labeling Dengue
antigen into reaction complex. Under the chromatographic action, the reaction
complex moves forwards along nitrocellulose membrane; it is separately captured
by anti-human IgG/IgM antibody precoated in test area on the nitrocellulose membrane.
In the test area, one red/pink reaction line is finally formed; at this time, a
positive result is indicated. On the contrary, when Dengue IgG/IgM antibody
does not exist in test sample and its concentration is lower than minimum
detection limit, the red/pink reaction line will not appear in test area; at
this time, a negative result is indicated. No matter whether Dengue IgG/IgM
antibody exists in test sample, one red/pink reaction line will be formed in
quality control area (C). The red/pink reaction line displayed in quality
control area (C) is the judgment criteria for whether the chromatographic
course is normal, and also the internal control standard for kit.
【Main
Component】
|
Ingredients
|
Quantity/Specification
|
Main components:
|
|
Test card (with desiccant)
|
1 test/bag
|
Each test card is mainly
composed of plastic casing and test strip. As main component of test strip,
the nitrocellulose membrane is coated with anti-human IgG/IgM antibody and
anti-rabbit IgG antibody. Binding pad is coated with colloidal gold labeled
Dengue antigen and goat anti-rabbit IgG antibody. Other components include:
polyester membrane and water absorbent paper.
|
|
Sample diluent
|
25 pieces/box
|
Mainly phosphate buffer solution (PBS) (0.1 M, pH7.2±0.2).
|
centrifugeStorage Conditions and Validity】
This kit is kept at 2~30℃, under sealed state of
aluminum foil bag. Its shelf life is 18 months. After the unsealing of aluminum
foil bag, this kit should be used within one hour. Production date and expiry
date are shown in the package or label.
【Sample Requirements】
1. Serum, plasma or whole blood.
2.
Whole
blood is collected through conventional method. The hemolytic sample can not be
used. All samples should be treated as infection factor.
3.
For
the sample of whole blood and plasma, only anticoagulants of EDTA, heparin and
sodium citrate can be used; other anticoagulants do not pass the test.
4.
The
sample of serum or plasma should be kept under room temperature (18~26℃) for
not more than one day, at 2~8℃ for not more than three days, and at -20℃ for
not more than one month. If the sample of whole blood can not be tested in time
within 2 hours, it should be kept at 2~8℃ for not more than three days.
5. Before the test, the sample must be restored to
room temperature. Only after the complete thawing, temperature restoration and
uniform mixing, the sample of frozen storage can be used.
【Test Method】
1.
Only
after the restoration to room temperature (20~25℃), the kit of low-temperature
storage can be used.
2.
External
package is torn off. Test card is taken out, and put flatly onto the surface of
horizontal operating table.
3.
Serum
sample is drawn through sucker, and then dripped vertically by 3~4 drops (about
80 uL) into sample injection hole. Whole blood sample is first dripped by 1
drop (about 20 uL), and then by 2~3 drops (about 40~60 uL) for dilution.
4.
After
15~20 minutes, display result is observed. The display result after 30 minutes
becomes insignificant.
【References】
[1]
Jang WS, Kwak SY, May WL, Yang DJ, Nam J, Lim
CS. Comparative evaluation of three dengue duo rapid test kits to detect NS1,
IgM, and IgG associated with acute dengue in children in Myanmar. PLoS One.
2019 Mar 13;14(3):e0213451.
[2]
Lee H, Ryu JH, Park HS, Park KH, Bae H, Yun S,
Choi AR, Cho SY, Park C, Lee DG, Lim J, Lee J, Lee S, Shin S, Park H, Oh EJ.
Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus
Non-Structural-1 Antigen and IgM/IgG Antibodies. Ann Lab Med. 2019
Nov;39(6):566-571 .
Cucunawangsih, Lugito NP, Kurniawan A.
Immunoglobulin G (IgG) to IgM ratio in secondary adult dengue infection using
samples from early days of symptoms onset. BMC Infect Dis. 2015 Jul 21;15:276..
【Basic Information】
Name of enterprise: Shenzhen Lvshiyuan
Biotechnology Co., Ltd.
Registered address: Room 101, 201 and 301,
Building D, National Biological Industrial Park of Marinelife, No.2 Binhai
Road, Dapeng, Shenzhen, China.
Production address: Room 101, 201 and 301,
Building D, National Biological Industrial Park of Marinelife, No.2 Binhai
Road, Dapeng, Shenzhen, China.
Unit of after-sale service: Shenzhen Lvshiyuan
Biotechnology Co., Ltd.
Production License No:
YueSiYaoJianXieShengChanXu No.20142513
Zip code: 518120
Tel: 086-755-28438788/28438000
Fax: 086-755-28938800
Email: info@lsybt.com
Website: http://www.lsybt.com