One-Step Dengue IgG/IgM Rapid Test Uncut Sheet

Dengue IgG/IgM Rapid Test Uncut Sheets
 
SAMPLE: Whole Blood / Serum / Plasma
FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY
 
Intended Use
The One Step Dengue IgA/IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgA, IgG and IgM) to dengue virus in Whole Blood /Serum / Plasma to aid in the diagnosis of Dengue viral infection.
 
Summary
Dengue is transmitted by the bite of an Aedes mosquito infected with any one of the four dengue viruses. It occurs in tropical and sub-tropical areas of the world. Symptoms appear 3—14 days after the infective bite. Dengue fever is a febrile illness that affects infants, young children and adults. Dengue haemorrhagic fever (fever, abdominal pain, vomiting, bleeding) is a potentially lethal complication, affecting mainly children. Early clinical diagnosis and careful clinical management by experienced physicians and nurses increase survival of patients. One step Dengue IgA/IgG/IgM Test is a simple, visual qualitative test that detects dengue virus antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.  
 
Principle
The One Step Dengue IgA/IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of dengue virus antibodies (IgA, IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing dengue recombinant envelope antigens conjugated with Colloid gold (dengue conjugates), 2) a nitrocellulose membrane strip containing three test lines (T1, T2and T3 lines) and a control line (C line). The T1 line is pre-coated with the antibody for the detection of IgA anti-dengue, The T2 line is pre-coated with the antibody for the detection of IgM anti-dengue, T3 line is coated with
antibody for the detection of IgG anti-dengue. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-dengue, if present in the specimen, will bind to the dengue conjugates. The immunocomplex is then captured by the reagent pre-coated on the T3 band, forming a burgundy colored T3 line, indicating a dengue IgG positive test result. IgM anti-dengue if present in the specimen will bind to the dengue conjugates. The immunocomplex is then captured by the reagent coated on the T2 line, forming a burgundy colored T2 line, indicating a dengue IgM positive test result. IgA anti-dengue if present in the specimen will bind to the dengue conjugates. The immunocomplex is then captured by the reagent coated on the T1 line, forming a burgundy colored T1 line, indicating a dengue IgA positive test result. Absence of any T lines (T1, T2and T3 lines) suggests 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 specimen has been added and membrane wicking has occurred.
 
Storage and Stability
Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
 
Additional Special Equipment
Materials Provided 
Test devices                          Disposable specimen droppers     
 Buffer                               
 
Package insert  Materials Required But Not Provided    
Timer                                   Centrifuge 
Specimen collection containers    
 
Precautions
1.For professional in vitro diagnostic use only. Do not use after expiration date.  
2.Do not eat, drink or smoke in the area where the specimens and kits are handled.  
3.Handle all specimens as if they contain infectious agents.  
4.Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.  
5.Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed. 
6.Follow standard biosafety guidelines for handling and disposal of potential infective material. 
 7.Humidity and temperature can adversely affect results.     
 
Specimen Collection and Preparation
1.The One Step Dengue IgA/IgG/IgM Test can be performed used on Whole Blood /Serum / Plasma. 
2. To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures. 
3. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. For long term storage, specimens should be kept below -20℃. Whole blood should be stored at 2-8℃ if the test is to be run
within 2 days of collection. Do not freeze whole blood specimens.
4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.