J. MITRA & CO. PVT. LTD. DENGUE NS1 Ag Quanti Card

DENGUE NS1 Ag
Q C
UANTI ARD
INTRODUCTION
Dengue virus is a flavivirus found largely in areas of the tropic and sub-tropics. There are
four distinct but antigenically related serotypes of dengue viruses, and transmission is by
mosquito, prinicipally Aedes aegypti and Aedes albopictus.
The mosquito-borne dengue viruses (serotype 1-4) cause dengue fever, a severe flu-like
illness. The disease is prevalent in third world tropical regions and spreading to sub-tropical
developed countries - including the United States. WHO estimates that 50-80 million cases
of dengue fever occur worldwide each year, including a potentially deadly form of the
disease called dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS).
Primary infection with dengue virus results in a self-limiting disease characterized by mild to
high fever lasting 3 to 7 days, severe headache with pain behind the eyes, muscle and joint
pain, rash and vomiting. Secondry infection is the more common form of the disease in
many parts of Southeast Asia and South America. IgM antibodies are not detectable until 5-
10 days in case of primary dengue infection and until 4-5 days in secondary infection after
the onset of illness. IgG appear after 14 days and persist for life in case of primary infection
and rise within 1-2 days after the onset of symtoms in secondary infection. This form of the
disease is more serious and can result in DHF and DSS. The major clinical symptoms can
include high fever, haemorrhagic fever, and circulatory failure, and the fatality rate can be as
high as 40%. Early diagnosis of DSS is particularly important, as patients may die within 12
to 24 hours if appropriate treatment is not administered.
Primary dengue virus infection is characterized by elevations in specific NS1 antigen levels
0 to 9 days after the onset of symptoms; this generally persists upto 15 days. Earlier
diagnosis of Dengue reduces risk of complication such as DHF or DSS, especially in
countries where dengue is endemic.
INTENDED USE
Dengue NS1 Ag Quanti Card is a sensitive immuno- chromatographic test for the qualitative
detection of Dengue NS1 Antigen in human Serum/ Plasma with iQuant Analyzer . This test
is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue
infection.
PRINCIPLE (ANTIGEN-ANTIBODY REACTION)
Dengue NS1 Ag Quanti Card is a fluorescence immunoassay based on sandwich principle.
The test area is coated with specific anti-dengue NS1 Ag antibodies. When a sample is
added to the cartridge, Dengue NS1 antigen if present will form a complex with another
specific NS1 antibodies conjugate to fluorochorme. On addition of Assay Buffer, this
complex migrates along the nitrocellulose membrane to the test region and forms an
antibody-antigen-antibody fluorescence immunocomplex. The result will be displayed by i-
Quant Analyzer.
MATERIALS PROVIDED
Dengue NS1 Ag Quanti Card kit contains following components to perform the assay:
a) Dengue NS1 Ag Quanti Card Device
c) Instruction Manual
KIT PRESENTATION
24 Test Pack
STORAGE AND STABILITY
The kit should be stored at 2-8ºC in the coolest and driest area available. Expiry date on the
kit indicates the date beyond which kit and its components should not be used. Dengue NS1
Ag Quanti Card should not be frozen and must be protected from exposure to humidity.
DESCRIPTION OF SYMBOLS USED
The following are graphical symbols used in or found on J. Mitra diagnostic products
and packing. These symbols are the most common ones appearing on medical devices and
their packing. They are explained in more detail in the British and European Standard
EN ISO 15223-1:2016.
Manufactured By
No. of tests
Lot Number
Batch Number
Manufacturing Date
Expiry Date
Do not use if package
is damaged
Single use only
b) Assay Buffer
48 Test Pack 96 Test Pack
In vitro diagnostic
medical device
See Instruction for use
Temperature
8ºC
Limitation
2ºC
Caution, see instruction for use
Catalogue Number
Keep away from sunlight
Fluorescence immunoassay (antigen-antibody) for
qualitative detection of Dengue NS1 Antigen in Human Serum/ Plasma
WARNING FOR USERS
CAUTION: ALL THE SAMPLES TO BE TESTED SHOULD BE HANDLED AS THOUGH
CAPABLE OF TRANSMITTING INFECTION. NO TEST METHOD CAN OFFER
COMPLETE ASSURANCE THAT HUMAN BLOOD PRODUCTS WILL NOT TRANSMIT
INFECTION.
1. The use of disposable gloves and proper biohazardous clothing is STRONGLY
RECOMMENDED while running the test.
2. In case there is a cut or wound in hand, DO NOT PERFORM THE TEST.
3. Do not smoke, drink or eat in areas where specimens or kit reagents are being
handled.
4. Tests are for in vitro diagnostic use only and should be run by competent person only.
5. Do not pipette by mouth.
6. All materials used in the assay and samples should be decontaminated before
disposal or by autoclaving at 121ºC at 15psi for 60 min. They should be disposed off
in accordance with established safety procedures and standard biosafety guidelines
for handling & disposal of potentially infective material.
7. Wash hands thoroughly with soap or any suitable detergent, after the use of the kit.
Consult a physician immediately in case of accident or contact with eyes, in the event
that contaminated material are ingested or come in contact with skin puncture or
wounds.
8. Spills should be decontaminated promptly with Sodium Hypochlorite or any other
suitable disinfectant.
9. Assay Buffer contains Sodium Azide as a preservative. If these material are to be
disposed off through a sink or other common plumbing systems, flush with generous
amounts of water to prevent accumulation of potentially explosive compounds. In
addition, consult the manual guideline "Safety Management No. CDC-22",
Decontamination of Laboratory Sink Drains to remove Azide salts" (Centre for
Disease Control, Atlanta, Georgia, April 30, 1976).
PRECAUTIONS
In order to obtain reproducible results, the following instructions must be followed:
1. Do not use the kit beyond the expiry date.
2. Do not mix reagents from different batches.
3. Do not open the foil pouch until it attains room temperature.
4. Do not re-use the test cartridge.
5. Follow the given test procedure and storage instructions strictly.
6. Do not paste any sticker or write anything on the QR-Code as this will lead to
erroneous result.
7. Do not temper the QR-Code as this will lead to erroneous result.
8. Do not touch the membrane with the pipette tip.
Important Note: Dengue NS1 Ag Quanti Card is only operational in conjection with
iQuant Analyzer.
SAMPLE / SPECIMEN COLLECTION AND STORAGE
1. Serum / plasma samples may be used with this test.
2. If serum / plasma specimens cannot be tested immediately, they should be
refrigerated at 2-8ºC. For storage for more than 3 days, freeze the specimen at -20ºC
or below.
3. Repeated freezing and thawing of the specimen should be avoided.
4. Specimens containing precipitate or particulate matter may yield inconsistent test
results. Such specimens must be centrifuged at 10,000 rpm for 15 minutes and the
clear supernatant should only be used for testing.
5. The use of hemolytic, lipaemic, icteric or bacterially contaminated specimens should
be avoided as it may lead to erroneous results.
BEFORE YOU START
The Assay Buffer Solution provided in the kit has closed nozzle and screw cap with pin
(outside). Before using Assay Buffer, keep the vial vertically straight and tap down gently on
the working platform, so that Assay Buffer comes down at the bottom of the vial. To
orifice/puncture the closed nozzle, follow the instruction as illustrated below: