Dengue IgM/ IgG Detection Kit (Colloidal Gold)

Short Description:

1.Jiqing offers CE authorized Dengue IgM/ IgG Rapid Test.
2.Quick Results
3.Detects Presence of antibody to Malaria in human body.
4.Made Start to Finish in China at CE Registered Facilities


  • Size: 1 Test/Kit,5 Tests/Kit, 10 Tests/Kit, 20 Tests/Kit, 25Tests/Kit,50 Tests/Kit
  • Product Detail

    Product Tags

    INTENDED USE

    The kit uses immunochromatography to qualitatively detect dengue virus IgM and IgG antibodies in human whole blood, serum or plasma.

    Dengue fever is caused by dengue virus (divided into four serotypes, DENV-1 ~ 4). It is an acute infectious disease transmitted by Aedes aegypti and Aedes albopictus. It occurs mostly in tropical and subtropical areas.Clinical types can be divided into dengue fever, dengue hemorrhagic fever and dengue shock syndrome.The main clinical manifestations include fever, headache, muscle and joint pain, extreme fatigue, rash, lymphadenopathy and leukopenia.Patients with initial infection of dengue virus usually have mild clinical manifestations, such as asymptomatic recessive infection, or mild and typical dengue fever;When re infected with dengue virus, the disease is more serious, the probability of dengue hemorrhagic fever and shock syndrome is increased, the mortality is high, it is a kind of infectious disease with serious harm.

    IgM was detected in the first infected patients from the 5th to 6th day of onset, and the antibody level rose to the highest level within 1 to 2 weeks, then decreased slowly, while IgG appeared around 14 days, which could exist for life; IgG antibody could be detected in the acute stage after secondary infection, and IgM level decreased significantly during the infection. IgG antibody positive, indicating the second infection with dengue virus or had been infected with dengue virus. Positive IgM antibody indicates the first infection with dengue virus (virus specific IgM antibody may appear not only in the first infection, but also in secondary infection and recurrent infection). IgG and IgM antibody positive, indicating the end of the primary infection or early secondary infection.

    The dynamic distribution of IgM and IgG antibodies is an important serological marker to infer primary infection and secondary infection.This product is suitable for the auxiliary diagnosis of dengue virus infection, as well as the identification of primary infection and secondary infection.

    Test Principle

    The reagent uses immunochromatography and capture method for rapid and qualitative detection of dengue virus IgG and IgM antibodies in human serum, plasma or whole blood.

    The nitrocellulose membrane detection area (T1, T2) of dengue virus IgG and IgM antibody test strip is coated with anti human IgG antibody and anti human IgM antibody respectively, and the quality control area (c) is coated with biotin. When the sample contains dengue virus IgG antibody and the concentration is higher than the minimum detection limit, the dengue virus recombinant antigen labeled with colloidal gold is mixed with whole blood, serum and serumDengue virus antibody IgG in serum or plasma combines to form a reactive complex. Under the action of chromatography, the reactive complex moves forward along the nitrocellulose membrane, and is captured by anti human IgG antibody precoated on the detection area (T1) of nitrocellulose membrane. Finally, a red reaction line is formed in the detection area (T1), and the result is positive for dengue virus IgG antibody;Similarly, when the sample contains dengue virus IgM antibody and the concentration is higher than the minimum detection limit, a visible red reaction line will be formed in the detection area (T2), and the result is dengue virus IgM antibody positive;On the contrary, when the sample does not contain dengue virus IgG, IgM antibody or the concentration is lower than the minimum detection limit, there is no red reaction line in the detection area (T1, T2), and the result is negative for dengue virus IgG / IgM antibody.Whether or not the sample contains IgG,IgM antibody will form a red reaction line in the quality control area (c).

    Main Components

    The reagent consists of test card, sample diluent (dropper) and pipette.
    1.  The test card consists of a test strip and a plastic box.The test strip is composed of nitrocellulose membrane, sample pad, bonding pad, absorbent paper, PVC board and other supports.The nitrocellulose membrane was coated with anti human IgG antibody, anti human IgM antibody and biotin, and the binding pad contained the recombinant antigen and avidin of dengue virus labeled with colloidal gold.
    2.  Sample diluent (drop bottle) 1 bottle / 25 people (sample diluent is PBS).
    3.  One straw per person.

    Storage conditions and validity

    1.Store at 4℃~40℃,the validity period is tentatively set for 24 months.
    2.After opening the aluminum foil bag, the test card should be used as soon as possible within 60 minutes. The sample diluent should be capped immediately after opening and placed in a cool place. Please use it within the validity period.
    3.Production date: see product label.
    4.Expiration date: see product label.

    Specimen Request

    Whole blood, serum and plasma samples can be used for testing.
    1.   Whole blood sample collection: use anticoagulant tube or blood collection vessel with anticoagulant added in advance (heparin, EDTA, sodium citrate and other anticoagulants are recommended) to collect blood from fingertip, earlobe tip or vein, and shake well for standby.Samples should be used as soon as possible after collection;If it can not be detected immediately, the sample can be stored at 2 ~ 8 ℃ for refrigeration, and the whole blood sample should be detected within 3 days.
    2.   Serum / plasma sample collection: venous blood is collected, and the supernatant is directly absorbed or centrifuged after blood coagulation.Blood samples were collected by collecting tube or anticoagulant tube with anticoagulant (heparin, EDTA, sodium citrate, etc. are recommended). After centrifugation or standing, the upper pale yellow clear liquid was taken as the plasma sample.If the serum / plasma samples can not be tested in time, they should be stored at 2 ~ 8 ℃ for two weeks. If they need to be stored for a long time, they should be stored at – 20 ℃. Before testing, they should return to room temperature.
    Note: high concentration of jaundice samples (the appearance of sample solution is yellow by naked eyes), high hemolytic samples (the concentration of free hemoglobin > 9g / L) or chylous blood samples with multiple flocculent deposits by naked eyes will interfere with the interpretation of test results, so the appearance of samples should be paid attention to before using samples.

    Testing method

    Please read the instructions carefully before testing. The samples to be tested, testing reagents and other testing materials are balanced to room temperature, and the testing should be carried out at room temperature.The operation steps are as follows:
    1. Tear along the incision of the aluminum foil bag, take out the test card, lay it flat on the table, and mark it (Note: do not touch the surface of the middle film of the test strip with your fingers).
    2. Suck the whole blood / serum / plasma sample with a short pipette (with scale), add 10ul (about 1 drop) vertically into the sampling hole, and then add 2 drops of diluent to the diluent area (as shown in Figure 1)
    3. The results were observed in 15-20 minutes, and there was no clinical significance in 30 minutes.

    See Figure 1 (for reference only)

    See Figure 1 (for reference only)

    Figure 2 (the pattern is for reference only, subject to the actual object)

    Figure 2 (the pattern is for reference only, subject to the actual object)

    Interpretation of test results

    Interpretation of test results (see Figure 2) negative: a red line, that is, only a red reaction line appears in the quality control area (c). It means that IgG and IgM antibodies have not been detected. In case of doubt, it is recommended to retest after 3-5 days.
    IgG antibody positive: there are two red lines, one in the test area (T1) and one in the quality control area (c). It means that they have been infected with dengue virus twice or have been infected with dengue virus before.
    IgM antibody positive: two red lines, namely one red reaction line in the test area (T2) and one red reaction line in the quality control area (c). It indicates the initial infection of dengue virus.
    IgG and IgM antibody positive: three red lines, that is, one red reaction line in the test area (T1, T2) and one red reaction line in the quality control area (c). It indicates the end of primary infection or the early stage of secondary infection.
    Invalid: there is no red reaction line in the quality control area (c). If the test is invalid, it is recommended to retest with a new test card at this time, especially pay attention to whether the sample amount is enough.

    Limitations of test methods

    1.   This reagent is only used to detect dengue virus IgG and IgM antibodies in human whole blood, serum or plasma.
    2.   Negative results do not rule out the possibility of recent infection.
    3.   The test must be carried out in strict accordance with the instructions, otherwise the wrong results may be produced;If the sample has individual drug or operation and technical reasons, the result will be wrong;If the result is suspicious, please retest.
    4.   This reagent only provides qualitative detection for dengue virus IgG and IgM antibodies in samples. If you need to detect the specific content of a certain index, please use relevant professional instruments.
    5.   The test results of this product are only for clinical reference, and should not be used as the only basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms / signs, medical history, other laboratory examinations, treatment reactions, epidemiology and other information.
    6.   In the early stage and the second stage of infection, dengue virus IgM antibody is not produced or the titer is very low, which will lead to negative results. If virus infection is suspected, the patient should be prompted to recheck within 3-4 days, take the second sample, and simultaneously detect the second sample and the first sample under the same conditions, so as to determine whether there is seroconversion or virus specific IgM antibody significantly increased in the first infection.
    7.   Patients with impaired immune function or receiving immunosuppressive therapy, such as patients with human immunodeficiency virus (HIV) infection or patients receiving immunosuppressive therapy after organ transplantation, have limited reference value for serological IgM antibody detection, which may lead to wrong medical interpretation.
    8.   In recent months, the analysis of the positive test results of the people who have received blood transfusion or other blood products should be cautious.
    9.   Virus specific IgM antibody may appear not only in primary infection, but also in secondary infection and recurrent infection.
    10.  There may be cross reaction between the reagent and the positive samples of Japanese encephalitis B. the diagnosis should be based on the clinical symptoms.

    Performance Characteristics

    1.The lowest detection limit:
    The lowest detection limit of IgG and IgM test cards was 1:40 for IgG and 1:20 for IgM

    2.Cross reaction
    (1)The reagent does not cross react with positive samples of measles, rubella, influenza A, typhoid, leptospirosis, hemorrhagic fever with renal syndrome, sepsis, epidemic cerebrospinal meningitis, hepatitis B virus, hepatitis C virus, AIDS and tsutsugamushi disease.
    (2)This reagent may cross react with positive samples of Japanese encephalitis B.

    3.Clinical trials:
    (1) IgG antibody: 1142 clinical samples were selected [400 positive samples were detected by ELISA or PCR, and 742 negative samples were detected by evaluation reagent. The positive coincidence rate was 32.25% (129 / 400), the negative coincidence rate was 98.79% (733 / 742), and the total coincidence rate was 75.48% (862 / 1142).
    (2) IgM antibody: 1142 clinical samples [345 positive samples and 797 negative samples detected by ELISA or PCR] were selected. The positive coincidence rate was 61.45% (212 / 345), the negative coincidence rate was 97.74% (779 / 797), and the total coincidence rate was 86.78% (991 / 1142).

     PROCAUTION

    1.  This product is a disposable in vitro diagnostic reagent, please do not reuse, expired products do not use.
    2.  There is desiccant in the aluminum foil bag, which should not be taken orally.
    3.  Fresh samples are recommended.
    4.It should be avoided that the temperature of the experimental environment is too high, and the test card stored at low temperature should be opened after being restored to room temperature to avoid moisture absorption.
    5.After the test, the used test card, sample diluent and pipette were treated as biomedical waste.
    6.Please pay attention to safety measures during operation, such as wearing protective clothing, gloves, etc.
    7. As with all diagnostic reagents, the final diagnosis should be made by the doctor after integrating the detection indicators and clinical symptoms.

    Index of CE Symbols

    Index of CE Symbols


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