Basic Info.

Origin

China

Origin

China

Product Desciption

Manufacturers Dengue IgG/IgM Rapid Test Kit
INTRODUCTION

The  Dengue IgG/IgM Serum/Plasma Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-dengue virus IgG and IgM in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with dengue viruses. Any reactive specimen with the Dengue IgG/IgM Serum/Plasma Rapid Test must be confirmed with alternative testing method(s).
SUMMARY
Dengue viruses viruses are transmitted by mosquitoes of the daytime-bitting Stegemyia family, principally Aedes aegypti, and Aedes albopictus. Serological detection is a common method for the diagnosis of infection with dengue viruses. IgM anti-dengue virus starts to appear at 3 days after initial exposure and remain in the circulation for about 30-60 days. IgG anti-dengue virus raise at around 7 days, peak at 2-3 weeks, and persist for the life.
The Dengue IgG/IgM Serum/Plasma Rapid Test detects IgG and IgM anti-dengue virus in one test within 10 minutes. The test is user friendly without cumbersome laboratory equipment.  
TEST PRINCIPLE
The  Dengue IgG/IgM Serum/Plasma Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a pink-rose colored conjugate pad containing recombinant dengue antigens conjugated with colloid gold (dengue conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with monoclonal anti-human IgM for the detection of anti-dengue IgM, T2 band is pre-coated with reagents for the detection of anti-dengue IgG, and the C band is pre-coated with goat anti rabbit IgG.
PRECAUTIONS
1.For professional and IN VITRO diagnostic use only.
2.The test should remain in the sealed pouch until use.
3.Do not use it after the expiration date.
4.All patient samples should be treated as if capable of transmitting disease.
5.The testing results should be read within 10 minutes after a specimen is applied to the sample well or sample pad of the device. Read result after 10 minutes may give erroneous results.
STORAGE AND STABILITY
1.The test kit is to be stored at refrigerator (2-8ºC) or at room temperature (up to 30ºC) in the sealed pouch.
2.The test device is stable through the expiration date printed on the sealed pouch.
3.The test device must remain in the sealed pouch until use.
4.Do not freeze the kit or expose the kit over 30°C.
SPECIMEN COLLECTION AND HANDLING
1.The Dengue IgG/IgM Serum/Plasma Rapid Test can be performed using serum or plasma.
2.separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days.  For long-term storage, specimens should be kept below -20°C.
3.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.
4.If specimens are to be shipped, they should be packed in compliance with national regulations covering the transportation of etiologic agents.
ASSAY PROCEDURE
Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3:  Make sure to label the device with specimen's ID number.

Step 4: Fill the pipette dropper with the specimen.
Holding the dropper vertically, dispense 2-3 drop (about 60-90 ml) of specimen into the sample well making sure that there are no air bubbles.

Step 5:  Set up the timer.
Step 6: Results can be read in 10 minutes.
 


INTERPRETATION OF ASSAY RESULT
1. NEGATIVE RESULT: If only the C band is present, the absence of any pink-rose color in the both T bands (T1 and T2) indicates that no anti-dengue virus antibodies are detected.  The result is negative.
2. POSITIVE RESULT:
2.1 In addition to the presence of C band, if only T1 band is developed, the test indicates for the presence of anti-dengue IgM.  The result is positive.
2.2 In addition to the presence of C band, if only T2 band is developed, the test indicates for the presence of anti-dengue IgG. The result is positive.
2.3 In addition to the presence of C band, both T1 and T2 bands are developed, this indicates for the presence of anti-dengue IgG and IgM. The result is also positive
Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.
3.INVALID: If no C band is developed, the assay is invalid regardless of any pink-rose color in the T bands as indicated below. Repeat the assay with a new device.