Chinese supplier hospitals demand dengue test diagnostic reagents

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High quality; Mutual-benefit priceFast deliveryBest service

Product Description
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********* Dengue IgG/IgM and NS1 test kit ********* 


China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent

 
Format
cassette
Specimen
Whole blood/serum/plasma
Accuracy
Over 99%
Read time
15mins
Expiry date
24-36months
Certificate
CE, FSC,ISO13485

Specification
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        ********* Dengue IgG/IgM and NS1 test kit *********
  

Product Principle of Dengue IgG/IgM and NS1 test kit

The Dengue Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection
of 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 testing
method(s) and clinical findings.

 

Product type 
cassette
Usual size
Cassette: 3.0 or 4.0mm 
Specimen 
Whole blood, serum/plasma
Application period 
Primary infection period or with symptoms
Type 1. Dengue IgG/IgM cassette Size:4.0mm
Type 2. Dengue NS1 test cassette Size: 3.0mm 4.0mm
Type 3. Dengue IgG/IgM & NS1 test cassette Size: 4.0mm
Storage Indoor temperature of 2-30 degrees 
Advantage easy to use, fast to read result, accuracy and stable application, private usage 

 
Product Paramenters
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Example of statistical results of reagent of 240 samples 
Reagent
           Control reagent kit
Positive                      Negative
 Total
 
Sensitivity: Se=100%
Specificity: Sp=100%
False positive rate =0%
False negative rate =0%
Total accordance rate = 100%
 
Positive 
100
0
100
Negative 
0
140
140
Total
100
140
240
REAGENT 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 room
temperature before opening. Do not freeze the kit or expose the kit over 30°C.


Specimen of Dengue IgG/IgM and NS1 Collection and Handling
For whole blood:
Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should be
refrigerated at 2-80C. Freezing is recommended if the storage periods are more than 3 days. They should be brought to
room temperature before testing. Using the specimen after long-term storage of more than three days can cause
non-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 blood
as soon as possible
 to avoid hemolysis. Use clear non-hemolyzed specimens when possible.


Procedure of Dengue 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,
                 and 2 drops(around 50μL) of specimen and 2 drops of buffer into the NS1 sample window.
                 But make sure 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 of Dengue IgG/IgM and NS1 test kit 

POSITIVE RESULT of DENGUE
IgG/IgM TEST 
IgG 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 and
2 (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.

 
       China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent                China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent
                            positive result

NEGATIVE AND INVALID RESULT of DENGUE IgG/IgM TEST 
NEGATIVE 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.

 
          China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent
                        Negative result 
           China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent
                        Invalid result 

RESULT of DENGUE NS1 TEST 
POSITIVE 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.

 
    
     China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent

 
        China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent

QUALITY CONTROL
An internal procedural control is included in the test. A colored line appears in the control line region (C), confirming
sufficient buffer volume and adequate membrane wicking.

 
WARNINGS AND PRECAUTIONS FOR Using Dengue 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
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Package: go as normal package or as per clients needs.
Out carton size:63*26*49CM; Gross weight: 13KG
Shipping: by sea or by air.

China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent

 
Company Profile
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*Nantong Diagnos Biotechnology Co., Ltd. (Diagnos) is a professional POCT (point-of-care testing)
manufacturer in China, found in 2006, specialized in researching, developing, manufacturing and
distributing 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, ISO13485
certificate and CE Mark already.

*Diagnos focuses on excellent client-centered support with experienced sales and marketing team that is
fluent in both Chinese and English, in addition to strong international import - export experience.
China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent
 
Our Advantages
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China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent
 
FAQ
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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: A professional QC team will control the goods quality during all the mass production or a third party inspection service
could 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
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For more details, please contact :

Holy Zhou
China Supplier Hospital Demanda Prueba De Dengue Diagnostic Reagent

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