HOFCARE Dengue NS1 Ag/IgG/IgM Combo Rapid Test Dosage/Direction for Use

Test Principle: Dengue NS1: In this test procedure, anti-Dengue NS1 antibody 2 is coated in the test line region (T). After a serum or plasma sample is placed in the sample well, it reacts with anti-Dengue NS1 antibody 1 labeled particles that have been applied to the colloidal gold conjugate pad. This mixture moves chromatographically along the length of the test strip and interacts with the coated anti-Dengue NS1 antibody 2. If the sample contains dengue virus NS1 antigen, a colored line will appear in the test line region (T) indicates a positive result. If the sample does not contain dengue virus NS1 antigen, a colored line will not appear in the test line region (T) indicates a negative result.
To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of sample has been added and membrane wicking has occurred.
Dengue IgG/IgM: When the sample contains the Dengue IgG or/and IgM antibody, it forms a complex with the colloidal gold labeled dengue recombinant antigen. The complex moves forward under the action of chromatography and combines with the mouse anti-human IgG or/and IgM antibody which coated at the T1 (IgG) or/and T2 (IgM) line to form a colored line (T1 or/and T2 line), indicates a positive result. When the sample does not contain the Dengue IgG or/and IgM antibody, no complex can be formed at the T1 or/and T2 line, and no colored line appears, which indicates a negative result.
Regardless of whether the Dengue IgM or/and IgG antibody is contained in the sample, the colloidal gold labeled Biotinylated BSA will bind with the coated streptavidin-conjugated IgG antibody at the C line to form a colored line (C line).
Sample Requirement: 1. The reagent can be used for the serum, plasma and whole blood samples.
2. Serum, plasma and whole blood samples must be collected in a clean and dry container. EDTA, sodium citrate, heparin can be used as the anticoagulants. Recommend to detect immediately after collecting blood. If blood coagulation occurs, serum sample is suggested to use.
3. Serum and plasma samples may be stored at 2-8°C for 1 week prior to assay, and at -20°C for 2 years. Frozen and refrigerated samples should be equilibrated to room temperature before detection and thoroughly mixed. Repeat freeze and thaw for no more than 3 times. Samples that exhibiting visible precipitates, stink or muddy should not be used.
4. Whole blood sample with anticoagulants may be stored at 2-8°C for 24 hours. It should be used immediately without anticoagulants. DO NOT FREEZE. Mix the sample well by gentle inversion of the tube immediately before testing.
Test Procedure: Instruction for use must be read entirely before taking the test. Allow the reagent to equilibrate to room temperature for 30 minutes (10-30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity ≤60%, Temp: 10-30°C). Use immediately when the humidity exceed to 60%.
Remove the test panel from the sealed pouch, place it on a clean and level surface with the sample well up.
Dengue NS1: Drop 4 drops (80-100 μL) of serum, plasma or whole blood vertically into the sample well of NS1. If the whole blood sample is thick, add 1 drop (40-50 μL) of sample diluent into the sample well of NS1.
Dengue IgG/IgM: Drop 1 drop (25 μL) of serum, plasma or whole blood vertically into the sample well of IgG/IgM, add 2 drops (80-100 μL) of sample diluent into the sample well of IgG/IgM.
Observe the test results immediately within 15-20 minutes, the results is invalid over 20 minutes.
Note: The diagram is for reference only. See the real object for details. The appearance and color of reagent components may be different from the actual product, which has no effect on normal use.
Result Explanation: Dengue NS1: Positive: Two distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
Negative: One colored line appears in the control region (C). No line appears in the test region (T).
Invalid: No colored lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
Dengue IgG/IgM: IgG and IgM Positive: Three distinct colored lines appear in the control region (C), the IgG test region (G) and the IgM test region (M), indicating the Dengue IgG and Dengue IgM positive.
IgG Positive: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the IgG test region (G), indicating the Dengue IgG positive.
IgM Positive: Two distinct colored lines appear. One line should be in the control region (C) and another line should be in the IgM test region (M), indicating the Dengue IgM positive.
Negative: One colored line appears in the control region (C). No line appears in the test region (G and M).
Invalid: No colored bands appear or control line fails to appear, indicating that the operator error or reagent failure.
Limitations: The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment.
Negative result may occur when detecting short-term infected samples or some second time infected samples, indicating that the specific antibodies of Dengue IgM does not exist or the concentration is below the detection limit. Some patients may not produce enough antibodies to be detected in their body within 7-10 days, it may show negative results. For some patients, if the Dengue infection is still suspected, they need to do a new Dengue rapid test 3-4 days later.
It is common to have serological cross-reactions with Flaviviruses (ie, between dengue types 1, 2, 3, 4 and St. Louis encephalitis, West Nile, Japanese encephalitis, yellow fever virus, etc.).
Samples with high concentrations of Rheumatoid factor or Heterophilic antibodies may cause false positive results.
A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.
It can not be used for screening the general population, but it can only be used for the screening of patients with clinical symptoms or when there is suspicious exposure.
The continued existed or not existed of antibodies can not be used to determine if the treatment is succeeded or not.
The best time for dengue testing is 6~14 days after the symptom of fever.
Quality Control: There are the test line and control line on the surface of the reagent. Neither the test line nor the control line is visible in the result window before applying a sample. The control line is used for procedural control and should always appear if the test procedure is performed properly and the test reagents of the control line are working.
The appearance of control line (C) is confirmed sufficient sample volume, adequate membrane wicking and correct procedural technique.