Dengue IgG/IgM Rapid Test Kit (Colloidal Gold) in vitro qualitative test of Dengue IgG/IgM antibody in the sample of hu

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】

【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. 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.

【Interpretation of Test Results】

Negative/Positive	Result	Significance
IgG(+)		Indicating a primary infection with Dengue virus.
IgM(+)		Indicating a secondary infection with Dengue virus.
IgG/IgM(+)		Indicating a secondary infection with Dengue virus.
Negative		Indicating no infection with Dengue virus.
Insignificant		Indicating that test strip is invalid and the sample should be retested.

【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. In the patients with early infection and some patients with secondary infection, detectable level of IgM antibody may be very low. At the first 7~10 days after the infection, the antibody of detectable level may not be produced in some patients.
3. Serological cross reaction is common between Dengue virus and jaundice virus (i.e. between Type 1/2/3/4 Dengue virus and virus of St. Louis encephalitis, Japanese B encephalitis and yellow fever).
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 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.
5. 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.
6. Interference test: At the test on following substances of specified concentration, interference phenomenon is not found.

【Precautions】

1. This kit is used only for in vitro diagnosis, and can not be reused.
2. This kit should be treated as containing infective materials.
3. All samples, reagents and potential contaminants should be disinfected and treated according to the relevant local regulations.
4. 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.
5. If there are too few Dengue antigens in the sample, false negative result may be caused.

[Interpretation of Signs]

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

【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 .

[3] 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