Treponema Pallidum (TP) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) in vitro qualitative test of Treponema Pallidum

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】

【Storage 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℃).

【Interpretation of Test Results】

1. Negative: In test card, only one purple-red line appears only at the position of quality control line; indicating that the corresponding antibody is not detected.

Graphic example: 

2) Positive: In test card, one purple-red line appears at the position of both test line and quality control line; indicating that the corresponding antibody is detected.

Graphic example:  

3) Ineffective:

In test card, the purple-red line does not appear at the position of quality control line; indicating that the test is ineffective and a retest is required through another test card.

【Limitations of Test Method】

1. This kit is used only for auxiliary diagnosis. Final clinical conclusion should be made through doctors by overall considering other diagnostic/examination results and test data.
2. Possible reasons for false negative result: The concentration of test substance is extremely high in the sample to produce HOOK effect; under the extreme condition, false negative result will be displayed. Some unknown compositions shield the antigenic determinant from binding with antibody.
3. Possible reasons for false positive result: Similar antibody or antigen of high concentration in the sample produces cross reaction. Some small molecular substances with similar antigenic determinant to that of Treponema Pallidum (TP) IgM/IgG antibody produce a nonspecific binding with colloidal gold labeled antibody.
4. Wrong results may also be caused by other factors, including: technological factors, misoperation and other sample factors.

【Product Performance Indicators】

1. Minimum detection limit: At the test on national reference material for test reagent of Treponema Pallidum (TP) IgM/IgG antibody (S1~S4) or enterprise internal control reference material for minimum detection limit (C1~C3), a positive result should be shown.
2. Coincidence rate of positive reference material: At the test on national positive reference material (P1~P8) or 10 portions of enterprise internal control positive reference material (P1~P10), coincidence rate of positive reference material should be 100%.
3. Coincidence rate of negative reference material: At the test on national negative reference material (N1~N20) or 10 portions of enterprise internal control negative reference material (N1~N10), coincidence rate of negative reference material should be 100%.
4. Intra-batch precision: From the kit of same batch, test card of 10 tests is randomly taken. Through the enterprise internal control reproducibility reference material (C1 and C2), a parallel test is made. The test results should all be positive; and the colority should be not obviously different under macroscopic observation.

Inter-batch precision: From the kit of continuous three batches (at least 3 tests for each batch), test card is randomly taken. Through the enterprise internal control reproducibility reference material (C1 and C2), a parallel test is made through the procedures stipulated in operating manual. The test results should all be positive; and the colority should be not obviously different under macroscopic observation.

5. Interference cross test: This kit is not interfered by 4 mg/mL hemoglobin, 0.5 mg/mL bilirubin and 30 mg/mL triglyceride.

【Precautions】

1. This kit is used only for in vitro diagnosis, and can not be reused.
2. No color bands appear on either the control or test lines, indicating that an error occurs and the test should be repeated.
3. Test environment should not be at too high temperature. Test card of low-temperature storage should first be restored to room temperature and then opened, so as to avoid a moisture absorption.
4. Before the use, the kit should be confirmed at intact state and as within shelf life.
5. As long as two lines of whatever colority appear in test area and quality control area within the judgment time, a positive result can be judged.
6. If there are too few Treponema Pallidum (TP) IgM/IgG antibodies in the sample, false negative result may be caused.

7. The desiccant in aluminum foil bag must not be taken orally.

8. If a damage of aluminum foil bag or kit is found before the use, the kit must not be used.

[Interpretation of Signs]

	Single-use		Storage temperature
	In vitro diagnostic instruments		Batch number
	Person/box		Refer to the specification

【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