ISO Ce Certified Dengue Rapid Test Kit Factory Price

Product Name: ISO Ce Certified Dengue Rapid Test Kit Factory Price Model NO.: DGNDEN-02 Logo Printing: OEM Group: Adult Quality Guarantee Period: Two Years Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization Material: Plastic and Paper Type: Test Strips & Test Tube Filter Rating: Normal Standard: En ISO 13485:2016 Shelf Time: 24 Months Specimen: Blood Application: Luteinizing Hormone Surge Stage Product Type: Cassette Size Regular: 3.0mm, 4.0mm Package: Foil Bag and Box and Carton Payment: Tt, Paypal, Western Union Sample: Available to Prepare Certificate: Ce, ISO Fsc Packing Size: 63*26*49cm Gross Weight: 13kg Trademark: Diagnos Transport Package: Carton Specification: Standard Origin: Jiangsu China HS Code: 3822001000 Product Description High quality;Mutual-benefit price;Fast delivery;Best serviceProduct Description¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯********* Dengue IgG/IgM and NS1test kit *********FormatcassetteSpecimenWhole blood/serum/plasmaAccuracyOver 99%Read time15minsExpiry date24-36monthsCertificateCE, FSC,ISO13485Specification¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ ********* Dengue IgG/IgM and NS1 test kit ********* Product Principle of Dengue IgG/IgM and NS1test kitThe Dengue Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detectionof dengue IgG/ IgM and virus antigen (Dengue Ag) in human whole blood, serum or plasma.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 Combo Rapid Test must be confirmed with alternative testingmethod(s) and clinical findings. Product typecassetteUsual sizeCassette: 3.0 or 4.0mmSpecimenWhole blood, serum/plasmaApplication periodPrimary infection period or with symptomsType 1. Dengue IgG/IgM cassette Size:4.0mmType 2. Dengue NS1 test cassette Size:3.0mm 4.0mmType 3. DengueIgG/IgM &NS1 test cassette Size:4.0mmStorageIndoor temperature of 2-30 degreesAdvantageeasy to use, fast to read result, accuracy and stable application, private usageProduct Paramenters¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯Example of statistical results of reagent of 240 samplesReagent Control reagent kitPositive NegativeTotalSensitivity: Se=100%Specificity: Sp=100%False positive rate =0%False negative rate =0%Total accordance rate =100%Positive1000100Negative0140140Total100140240REAGENT PREPARATION AND STORAGE Store test device unopened at 2°C-30°C.If stored at 2°C-8°C, ensure that the test device is brought to roomtemperature before opening. Do not freeze the kit or expose the kit over 30°C.Specimen of Dengue IgG/IgM and NS1 Collection and HandlingFor whole blood:Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should berefrigerated at 2-80C. Freezing is recommended if the storage periods are more than 3 days. They should be brought toroom temperature before testing. Using the specimen after long-term storage of more than three days can causenon-specific reaction. When stored at 2-8 0C, the whole blood sample should be used within three days.For serum/plasma:Blood should be collected aseptically into a clean tube without anticoagulants. Separate the serum or plasma from bloodas soon as possibleto avoid hemolysis. Use clear non-hemolyzed specimens when possible.Procedure ofDengue IgG/IgM and NS1 test kit> 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: For whole blood samples: Fill the dropper with the specimen then add 10μL of specimen and 2 drops of buffer into the IgG/ IgM window, and2 drops(around 50μL) of specimen and 2 drops of buffer into the NS1 sample window. But makesure that there are no air bubbles. For Plasma/ Serum samples: Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 5 μL of specimen and 2 drops of buffer into the IgG/ IgM and 1 drop (around 25μL) of specimen and 2 drops of buffer into NS1 sample well, making sure that there are no air bubbles. >Step4: Results can be read in 15 minutes. Don't read results after 30 minutes.How to read the result ofDengue IgG/IgM and NS1 test kitPOSITIVE RESULT of DENGUE IgG/IgMTESTIgG POSITIVE:The colored line in the control line region (C) appears and a colored line appears in test line region 1 (T1).The result is positive for Dengue virus specific-IgG and is probably indicative of secondary Dengue infection.IgM POSITIVE:The colored line in the control line region (C) appears and a colored line appears in test line region 2 (T2).The result is positive for Dengue virus specific-IgM antibodies and is indicative of primary Dengue infection.IgG AND IgM POSITIVE:The colored line in the control line region (C) appears and two colored lines should appear in test line regions 1 and2 (T1 and T2).The color intensities of the lines do not have to match.The result is positive for IgG & IgM antibodies and is indicative of secondary Dengue infection. positive resultNEGATIVE AND INVALID RESULT of DENGUE IgG/IgMTESTNEGATIVE RESULT:The colored line in the control line region (C) appears. No line appears in test line regions 1 or 2 (T1 or T2). INVALID RESULT:Control band fails to appear.Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure.Review the procedure and repeat the procedure with a new test device.If the problem persists, discontinue using the test kit immediately and contact your local distributor. Negative result Invalid resultRESULT of DENGUE NS1TESTPOSITIVE RESULT:Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T). NEGETIVE:only one colored band appears in the control region (C). No apparent colored band appears in the test region (T). INVALID:Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor. QUALITY ConTROL An internal procedural control is included in the test. A colored line appears in the control line region (C), confirmingsufficient buffer volume and adequate membrane wicking. WARNINGS AND PRECAUTIONS FOR UsingDengue IgG/IgM and NS1 test kit≡1. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.≡2. Do not open the sealed pouch, unless ready to conduct the assay.≡3. Do not use expired devices.≡4. Bring reagents to room temperature (15°C-30°C) before use.≡5. Do not use the components in any other type of test kit as a substitute for the components in this kit.≡6. Do not use hemolized blood specimen for testing. ≡7.Wash hands thoroughly after performing the test.≡8. Users of this test should follow the US CDC Universal Precautions for prevention of transmission of HIV, HBV and other blood-borne pathogens. ≡9. Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled. Packing &Delivery¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯Package: go as normal package or as per clients needs.Out carton size:63*26*49CM; Gross weight: 13KGShipping: by sea or by air.Company Profile¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯*Nantong Diagnos Biotechnology Co., Ltd. (Diagnos) is aprofessional POCt (point-of-care testing)manufacturer in China, found in 2006, specialized in researching, developing, manufacturing anddistributing advanced medical instruments and in-vitro medical diagnostic products.*Diagnos offers quality products in the following specialties: Fertility, Infectious Diseases, Tumor Markers,Cardiac Markers, Substance of Drug Abuse tests and etc.*With the strong support from the government, Diagnos has obtained ISO9001 certificate, ISO13485certificate and CE Mark already.*Diagnos focuses on excellent client-centered support with experienced sales and marketing team that isfluent in both Chinese and English, in addition to strong international import -export experience.Our Advantages¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯FAQ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯1.Q: Sample available?A: Reasonable quantity free samples will be available to sent for quality evaluation.2.Q: Do you have minimum order quantity requirements?A: Yes, but quantity can be negotiated.3.Q: Can we visit your factory?A: sure, welcome you to visit our factory any time.4.Q: How to ensure the cargo quality?A: Aprofessional QC team will control the goods quality during all the mass production or athird party inspection servicecould be arranged at your expense if you want. We will supply bulk sample for evaluation before shipping.6.Q: Which certificates do you have?A: We already got CE 0123, ISO13485 and ISO 9001 certificate.7.Q: How to pay?A: Payment can be made by paypal, western union, bank transfer, etc.Contact information¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯For more details, please contact :Holy Zhou