Hospital Detection Dengue Igg/Igm Ns1 Test Kits Ivd Rapid Diagnostic Tests

• Customization: Available
• Type: Test Strips & Test Tube
• Material: Plastic
• Model NO.: DINS1
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult
• Logo Printing: With Logo Printing
• Delivery: Two Weeks
• Transport Package: Cartons
• Specification: strips/cassette
• Trademark: No
• Origin: China
• HS Code: 3822190090
• Production Capacity: 10000000000PCS/Year

Product Description

Dengue virus NS1 antigen in human serum, plasma or whole blood was qualitatively detected by immunochromatography. It is suitable for early auxiliary diagnosis and screening of dengue virus infection.
Dengue fever is caused by dengue virus (divided into four serotypes, DENV-1-4). Acute infectious diseases transmitted by Aedes aegypti and Aedes albopictus are common in tropical and subtropical areas. The clinical types can be divided into dengue fever, dengue hemorrhagic fever and dengue shock syndrome. The disease spreads rapidly and its main clinical manifestations include fever, headache, pain in muscles and joints, extreme fatigue, rash, enlargement of lymph nodes and leukopenia. Initial infection of dengue virus patients, the general clinical manifestations are mild, can be asymptomatic recessive infection, or light, typical dengue fever; re-infection of dengue virus, the disease is more serious, clinical occurrence of dengue hemorrhagic fever and shock syndrome increased, the mortality rate is high, is a serious hazard. Infectious Diseases.

Inspection Principle
The dengue virus NS1 antigen in human serum, plasma or whole blood was detected by immunochromatography and double antibody sandwich assay.

Main Components
The kit consists of a test card, a straw and a manual.

Storage Conditions and Effectiveness Period
The product is stored at 2 ~30 °C and has a validity period of 24 months.  After the aluminium foil bag is opened, the test card should be used as soon as possible within 1 hour.

Sample requirements
Sample collection of serum/plasma: venous blood is collected. After blood coagulation, the supernatant is directly absorbed or centrifuged, which is called serum. Blood samples were collected by collecting tube or anticoagulant tube with anticoagulant (heparin, EDTA, sodium citrate, etc.) and then centrifuged or stationed to collect superficial yellowish clear liquid. If serum/plasma samples cannot be tested in time, they should be stored at 2-8°C for two weeks. If long-term storage is needed, they should be frozen at - 20°C, and should be restored to room temperature before testing.
Note: High concentration of jaundice samples (the appearance of the sample solution is yellow by naked eye observation), high hemolysis samples (the concentration of free hemoglobin > 9g/L) or chylous blood samples with flocculent deposits visible to naked eye will interfere with the interpretation of the test results, so the appearance of samples should be paid attention to before using the samples.

Test Method
Before testing, please read the instructions carefully. Samples, reagents and other testing materials should be balanced to room temperature. Testing should be carried out at room temperature.
1. Tear apart along the incision of the aluminium foil bag, take out the test card and place it on the table.
2. Serum/plasma samples were taken by suction tube and 3-4 drops (about 80 u l) were added vertically into the sampling hole.
3. The results were observed within 20 minutes and showed no clinical significance after 30 minutes.




INTERPRETATION OF RESULTS
 

• Negative:  Only one colored band appears on the control (C) region.  No apparent band on the test (T) region.

 

• Positive:  In addition to a pink coloured control (C) band, a distinct pink colored band will also appear in the test (T) region.

 

• Invalid:  A total absence of color in both regions is an indication of procedure error and/or the test reagent has deteriorated.

Limitations of test methods
1. This reagent is only used to detect dengue virus NS1 antigen in human serum and plasma.
2. Negative results will occur when the dengue virus antigen NS1 in the test sample is below the minimum detection limit or does not exist at a certain stage of infection. Negative results do not exclude the possibility of recent infection.
3. The test must be carried out strictly according to the instructions, otherwise erroneous results may occur; if there are individual medicines or operational and technical reasons in the sample, the results will be wrong; if the results are suspicious, please retest.
4. This reagent only provides qualitative detection for the NS1 antigen of dengue virus in samples. For the specific content of a certain index, please use relevant professional instruments.
5. The results of this product are only for clinical reference, and should not be the only basis for clinical diagnosis and treatment. Clinical management of patients should be combined with their symptoms/signs, medical history, other laboratory examinations, treatment response and epidemiological information.

STORAGE AND STABILITY

The test kit can be stored at room temperature (2 to 30°C) in the sealed pouch to the date of expiration.  The test kit should be kept away from direct sunlight, moisture and heat.

PRECAUTION
 

1. For in vitro diagnostic use only.
2. Do not use test kit beyond expiry date.
3. The test device should not be reused.

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