Treponema Pallidum (TP) IgM/IgG
Antibody Rapid Test Kit (Colloidal Gold)
【Product Name】
Generic name: Treponema Pallidum (TP) IgM/IgG
Antibody Rapid Test Kit
(Colloidal Gold)
【Packing Specification】
25 tests/box
【Intended
Use】
This kit is applicable for in
vitro qualitative test of Treponema Pallidum (TP) IgM/IgG antibody in the
sample of human whole blood.
Clinically, this kit is
applicable for auxiliary diagnosis of syphilis.
【Test
Principle】
By the immunochromatographic
technique, this kit tests the Treponema Pallidum (TP) IgM/IgG antibody through
double antigen sandwich method. At the test, the treated extract is dripped
into sample injection hole of test card. When Treponema Pallidum (TP) IgM/IgG
antibody exists in test sample and its concentration is higher than minimum
detection limit, Treponema Pallidum (TP) IgM/IgG antibody first forms with
labeling antibody into reaction complex. Under the chromatographic action, the
reaction complex moves forwards along nitrocellulose membrane; it is separately
captured by Treponema Pallidum (TP) IgM/IgG antibody ribosomal monoclonal
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 Treponema Pallidum (TP) IgM/IgG
antibody does not exist in test sample or 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 Treponema
Pallidum (TP) IgM/IgG 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 Treponema Pallidum (TP) IgM/IgG
antibody ribosomal monoclonal antibody and anti-rabbit IgG antibody. Binding
pad is coated with colloidal gold labeled Treponema Pallidum (TP) IgM/IgG
antibody monoclonal antibody and colloidal gold labeled mouse 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.
Whole
blood is collected through conventional method. The hemolytic sample can not be
used. All samples should be treated as infection factor.
2.
Whole
blood samples are limited to EDTA, heparin, and sodium citrate as
anticoagulants, and other anticoagulants have not been tested.
3.
The
whole blood sample should be kept under room temperature (18~26℃) for not more
than one day; if there is no contamination such as bacteria, the sample should
be kept at 2~8℃ for not more than seven days
4.
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,
the kit and collected test sample of low-temperature storage can be used.
2. Aluminum foil bag is torn off. Test card is
taken out, and put flatly onto the surface of operating table.
3. Whole blood sample is drawn through pipette
separately at 10 uL, and then dripped into sample injection hole of test card.
The cap of bottle for sample buffer solution enclosed in the kit is rotated
off; and the bottle for sample buffer solution is inverted. The sample buffer
solution is dripped vertically by 3 drops (about 80 uL) into sample injection
hole. Then, the timing is started.
4. At 10~15 minutes, final result is read. After 15
minutes, test result must not be read.
5. Note: The test had better be completed under
room temperature (15~30℃).
【References】
[1]
ToalBurns J, Davenport M. Adjuvant treatments
for biliary atresia. Transl Pediatr. 2020 Jun;9(3):253-265. doi:
10.21037/tp.2016.10.08. PMID: 32775244; PMCID: PMC7347763.
[2]
Patel DR, Neelakantan M, Pandher K, Merrick J.
Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020
Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01. PMID: 32206590; PMCID:
PMC7082248.
[3]
Isayama T. The clinical management and
outcomes of extremely preterm infants in Japan: past, present, and future.
Transl Pediatr. 2019 Jul;8(3):199-211. doi: 10.21037/tp.2019.07.10. PMID:
31413954; PMCID: PMC6675688.
【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