Human Parvovirus B19 rapid cassette

This Rapid test for IgM Antibody to Human Parvovirus B19 (Colloidal Gold) is pre-determined for the qualitative detection of the human Parvovirus B19 IgM antibody present in the human whole blood, serum or plasma samples. It is used as an early infection detection of Parvovirus in immunodiagnostics or hematological disease in the hemolytic anemia patients, pregnant women, newborns, etc. It serves as auxiliary diagnostic reagents in the clinical diagnosis.

SUMMARY

Human parvovirus (HPV B19) is the only pathogen of the genus Parvovirus that is pathogenic to humans. It belongs to the family of Parvoviridae and genus of erythropoiesis. Parvoviruses are mainly transmitted through the respiratory and bloodstream with an incubation period of 6 to 8 days. For people with normal immunity, it does not cause any symptoms or mild symptoms. Infections in patients with immunodeficiency or blood diseases can cause complications such as arthritis and vasculitis or secondary infections; in patients with hemolytic anemia will develop temporary aplastic anemia; chronic inhibition of erythropoiesis and symptoms of chronic anemia. Early pregnancy can cause miscarriage, fetal malformation or stillbirth; in addition, Parvovirus B19 is also the cause of infectious rash in children. After its infection the symptoms usually appear within 3 days. At this stage, 90% of patients can be detected for IgM antibodies; IgG antibodies appear after about 2 weeks; IgM usually disappears in 2 to 3 months after the disease. There are many methods for detecting B19 infection, such as immunoelectron microscopy and receptor-mediated hemagglutination test, but the commonly used detection methods in the laboratory are still nucleic acid detection and serological detection.

PRINCIPLES OF THE ASSAY

The colloidal gold-labeled mouse anti-human IgM is coated on the gold standard pad, and the recombinant human Parvovirus B19 antigen is coated on the nitrocellulose membrane. If the sample is a positive specimen then the human parvovirus B19 IgM antibody in the specimen is combined with the colloidal gold. The mouse-anti-human IgM binds to form an immune complex, and the complex with the sample flow forward inside the nitrocellulose membrane due to chromatography. When the complex passes through the T line, it binds with coated human parvovirus B19 antigen to form the complex and agglomerate and display a colored line. The remaining colloidal-gold labeled mouse-anti-human IgM binds to the C-line coated goat anti-mouse IgG antibody to agglutinate color development. If the sample is negative, means the sample does not contain human parvovirus B19 IgM antibody, resulting in the inability to form an immune complex and color only appears only in the C line.

MATERIALS PROVIDED

Each box contains as below:

• Test card (T-line coated with recombinant human parvovirus antigen (VP1), coated with goat-anti-mouse IgG antibody on C line, coating buffer: 0.05 M PBS pH 7.4): 1 test× 20

• Sample diluents: 1 bottle × 5 ml.

• Manual: 1 copy

SAMPLE REQUIREMENT

• Serum samples are collected from the intravenous method by the conventional method. Plasma sample: add 100ul heparin solution (1%) to 5 to 10ml of blood; or sodium citrate solution (3.8%) to plasma according to the proportion of 1:9; or EDTA solution (15%) 0.04ml to 5ml plasma.

• Serum and plasma samples can be stored at 4℃ if test is done within 5 days or else store for more than 5 days store at -20 ℃ and not more than 3 times of freeze-thaw.

• Whole blood samples are recommended to be tested within 3 days and should be stored at 2 to 8 °C, do not freeze.

• The test result is invalid for hemolytic sample.

TEST PROCEDURE

• Test preparation: 1μL, of each of 10μL, 50μL and 100μL micropipettes, and matched tips or dropper (10μL, 50μL, 100μL)

• Test process: Make sure that before the test the temperature of the kit and the sample should be the same with the room temperature. Place the test card on a horizontal dry work surface. Add 10μL serum or plasma sample into the sample well then add 20μL of whole blood to each well of the test card using a micropipette, add 80μL of the sample dilution. Observe the result in 15 to 20 minutes. The observation is invalid after 20 minutes.

• Precautions taken during the inspection process: The test kit and the sample to be tested should be placed at room temperature before being tested. Use the test card within 30 minutes after opening it.

INTERPRETATION OF RESULTS

• Positive: If two pink lines appear in both the C and T position

• Negative: If only one pink line appears in the C position

• Invalid: If the control line next to the test line is not visible within 10 minutes after the addition of the sample.

Note: Invalid result should be treated as infectious contaminants and samples should be re-acquired.

LIMITATIONS

• The test results of this product are interpreted by human and are subjected to visual errors or subjective judgment. Therefore, when the color of the strip is difficult to determine it clearly, it is recommended to repeat the test.

• This test card is one of the auxiliary means of diagnosis and the test result is for reference only so, should not be taken as the sole basis for clinical diagnosis and treatment. The positive result should be further confirmed by other methods also, the detection result is limited by the sensitivity of the test. The negative result may be due to low antibody concentration, due to the sensitivity of product analysis. Clinical diagnosis should be combined with clinical examination, medical history and other tests.

• In the early stage of infection, IgM is not produced or the titer is very low that may lead to negative result. Patients should be reminded to review within 7 to 14 days. At the same time, the last collected specimens should be tested in parallel to confirm whether there is serological positive or significant titer rise.

• Patients with impaired immune function or immunosuppressive therapy have limited reference values for serological antibody testing.

• This reagent is a qualitative test and cannot be used to determine the antibody content.

• This reagent is for the detection of individual whole blood, serum or plasma samples do not use it for the detection of saliva, urine or other body fluids.

PRECAUTIONS

• The positive result detected by the kit further needed to be confirmed by other methods.

• The kit should be sealed and protected from moisture when the humidity is 60% or less, should be used within 1 hour of opening and if the humidity is more than 60%, avoid keeping in the air for too long, that can cause moisture absorption and affect the test results.

• The depth of the color of the test line is not necessarily related to the titer of the antibody in the sample. The result after 20 minutes is invalid.

• When the human parvovirus B19IgM antibody content in the specimen is extremely high, the C-line band may be weak, which is normal.

• The kit components and the waste generated by the test should be treated as infectious contaminants.

• This reagent is for in vitro diagnosis only.

STORAGE AND STABILITY

Store at room temperature between 4 to 30° C and the shelf life is of 24months. Do not use the kit beyond its expiry date.