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Dengue IgG + IgM AB test device

Dengue NS1 Ag Test

Dengue NS1 Ag Test Device
For qualitative detection of Dengue NS1 Antigen in human serum / plasma




Intended use

OSCAR Dengue antigen test is a rapid card test for qualitative detection of NS-1 antigen in human serum / plasma for early diagnosis of dengue.

Introduction

Dengue is caused by any of the four closely related dengue viruses (DEN-V1, DEN-V2, DEN-V3 & DEN-V4). The viruses are transmitted to human by the day biting mosquito Aedes aegypti and Aedes albopictus. Dengue hemorrhagic fever (DHF) is a more severe form of dengue infection and it can be fatal if undetected and not treated in a timely manner.

Non Structural Protein (NS1) is highly-conserved glycoprotein that is present at high concentration in the sera of dengue infected patients during the early clinical phase of the disease. NS1 antigen is found from the first day and last up to 9 days after onset of fever in some of the primary or secondary dengue infected patients.NS1 Ag appears in serum / plasma before the onset of IgM & IgG antibodies and its detection in suspected dengue patient can be used as an early marker for the disease.

OSCAR Dengue NS-1 test is designed for qualitative detection of NS 1 Ag in human serum / plasma as an aid for the early diagnosis of Dengue.

Test Principle

This test device contains a strip composed of a sample pad, conjugate pad, nitrocellulose membrane (NCM) and absorbent pad. The conjugate pad contains dried colloidal gold conjugated with anti dengue NS-1. The NCM is immobilized with anti-dengue NS1 Ag at the test line region T and another protein as visual control at control line region C. Test line and the control line in result window are not visible before applying any sample.

When a serum / plasma sample containing Dengue NS1 Ag is applied in sample well of test device, it solubilises the gold conjugate dried on conjugate pad and makes an immune complex. This complex moves chromatographically and is captured by the test line protein resulting in appearance of pink / purple line at 'T region. The appearance of another pink / purple line at C region validates the test and is used as procedural control and should always appear if the test procedure is performed correctly. If no pink / purple line appear at T region then the sample has no dengue NS1 Ag. Pink/Purple line at T & C indicates positive reaction and the specimen has NS1 Ag.

Kit Components:

1. Test card pouches: Each pouch contains a plastic housing placed with a strip which has dried colloidal gold conjugated with mouse monoclonal anti dengue NS-1 and rabbit IgG, nitro cellulose membrane is immobilised with monoclonal anti dengue NS-1 at test line region and goat anti rabbit IgG at control line region. A disposable sample dropper is placed inside each pouch along with a desiccant pouch. 2. Product insert

Kit Storage and Stability:

The OSCAR Dengue NS1Ag test should be stored between 2-30C. The test components are stable up to the date of expiry mentioned on the pouch if stored at recommended storage in sealed condition. The test card is sensitive to humidity and as well as to high temperature and do not expose to extreme conditions.

Precautions:

1. Test is only for in-vitro diagnosis.
2. Disposable card for single use only.
3. Serum or plasma is preferred choice as specimen.
4. Do not use it beyond the expiration date.
5. Do not run the test under or in front of high flow of air.
6. Use separate disposable dropper or pipette tips for each sample in order to avoid cross-contamination of either samples which could cause erroneous results.
7. Do not eat or smoke while handling specimens.
8. Wear protective gloves while handling specimens. Wash hands thoroughly afterwards.
9. Avoid splashing or aerosol formation. Clean up spills thoroughly using an appropriate disinfectant.
10. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials, as if they were infectious waste, in a bio-hazard container.
11. Do not use the test kit if the pouch is damaged or the seal is broken.

Specimen Collection & Storage:
Collect the whole blood into the collection tube (with or without anticoagulants) by venipuncture. Allow to clot or wait for RBC to settle down. Centrifuge the tube and remove serum / plasma. Optimal results were obtained when patient samples were tested immediately after collection. If plasma or serum specimens are not tested immediately, they should be refrigerated at 2-8C. For storage period longer than 2 weeks, freezing is recommended. They should be brought to room temperature prior to use. Plasma or serum specimens containing a precipitate may yield inconsistent test results. Such specimens must be clarified prior to assaying.