Dengue IgM IgG rapid test cassette by whole blood serum plasma

Dengue IgM/IgG rapid test cassette by whole blood/serum/plasma
Product Description
Introduction
The Dengue IgM/IgG Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections. For professional in vitro diagnostic use only.
Test Cassette
Package
Parameter Product Namedengue IgM/IgG rapid test cassetteSize3.0mm/4.0mm for your designedFormatCassetteSpecimenSerum/Plasma/Whole bloodAccuracyOver 99%CertificateCE/ISO/FDARead Time15minWarrantyRoom temperature 24 monthsOEMAvailable
Materials
• Materials Provided
1.Cassette device 2.Drpper 3.Buffer 4.Desiccant 5.Package insert
• Materials Required But Not Provided
1.Specimen collection containers 2.Lancets(for fingerstick whole blood only) 3.Centrifuge 4.Micropipette
5.Timer
Feature
1.High sensitivity;
2.High accuracy;
3.Read results within 15 minutes;
4.Individual package,Easy to use;
5.Home self-test,Protect privacy;
Directions For Use
Allow test device, specimen, and/or controls to equlilibrate to room temperature(15-30°C) prior to testing.
1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5μL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80μL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S)
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line. and transfer 1 drop of whole blood (approximately 10μL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80μL) and start the timer. See illustration below.
To use a micropipette: Pipet and dispense 10 μL of Whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 10μL) and start the timer. See illustration below.
3.Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 15 minutes.
Interpretation Of Results
• POSITIVE
IgM POSITIVE: The colored line in the control line region (C) changes from red to blue, and a colored line appears in test line region 1(IgM). The result is positive for Dengue virus specific-IgM and is probably indicative of primary Dengue infection.
IgG POSITIVE: The colored line in the control line region (C) changes from red to blue, and a colored line appears in test line region 2(IgG). The result is positive for Dengue virus specific-IgG and is probably indicative of primary Dengue infection.
IgM AND IgG POSITIVE: The colored line in the control line region (C) changes from red to blue, and two colored lines should appear in test line regions 1 and 2 (IgM and IgG). The color intensities of the lines do not have to match. The result is positive for IgM & IgG antibodies and is indicative of secondary Dengue infection.
• NEGATIVE
The colored line in the control line region (C) changes from red to blue. No line appears in test line regions 1 or 2(IgM or IgG).
• INVALID
Control line (C) is still completely or partially red, and fails to completely change from red to blue. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure.
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Certifications
Dengue IgM/IgG rapid test cassette by whole blood/serum/plasma
Packaging & Shipping
PACKAGE:
1pcs/foil pouch, 100pcs/box, 5000/cartonDELIVERY TIME:
1-2 weeks after confirming order,detail delivery date should be decided according to production season and order quantity.
Company Information
about US
Xiamen Useful Imp & Exp Co., Ltd. Is Professional Supplier And Exports of Medical Consumable,Rehabilitation Treatment Device and Lab Consumable in China.We offer a wide range of products from Chinese healthcare providers.These productions all certificated by CE European,part of them also certificated by FDA and we supply clients with OEM or ODM or OBM.
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Contact Us
Welcome to inquire!
Phone:+86 18030160816
Whatsapp:+86 13625018293
Skype: live:9889d04efee72a41
Address:Unit G, Fl. 11, Bldg 1#, Wuyuanwan Operation Center, No. 601,
Sishui Rd, Huli District, Xiamen, China.Go to homepage