Basic Info.
Model NO.
DGND-NS1
Group
Adult
Material
Plastic and Paper
Logo Printing
OEM
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
Transport Package
Carton
Specification
Standard
Trademark
Diagnos
Origin
Jiangsu China
HS Code
3822001000
Production Capacity
5000000 PCS/Month
Product Description
High quality; Mutual-benefit price; Fast delivery; Best service
Product Description
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
********* Dengue IgG/IgM and NS1 test kit *********
| Format | cassette |
| Specimen | Whole blood/serum/plasma |
| Accuracy | Over 99% |
| Read time | 15mins |
| Expiry date | 24-36months |
| Certificate | CE, FSC,ISO13485 |
Specification
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
********* Dengue IgG/IgM and NS1 test kit *********
Product Principle of dengue igg igm 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
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
Example of statistical results of reagent of 240 samples
| Reagent | Control reagent kit Positive Negative | Total | 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.
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.
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.
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.
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.
 |  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.
 Negative result |  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.
 |  |
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.
≡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: 13KG
Out carton size:63*26*49CM; Gross weight: 13KG
Shipping: by sea or by air.
Company Profile
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
*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.
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
*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.
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: 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.
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.