Dengue IgG/IgM/NS1 Whole Blood Complete Test Kit

Dengue IgG/IgM/NS1 Whole Blood Complete Test Kit

  • Format:聽complete kit
  • Cassette Size: 4.0mm
  • Specimen:聽Serum, Plasma, Whole Blood
  • Accuracy over 99.4%
  • Results read in聽15 minutes
  • Methodology: Colloidal gold
  • Shelf time: 2 years
  • Description
  • Instruction for Use
  • Ordering Information
  • Inquiry

HENSOtest Dengue IgG/IgM/NS1 Whole Blood Complete Test Kit is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies and non-structural protein antigen to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of Dengue infections.

 

Whole kit contain:

Combo card + dropper + Desiccant + Buffer + Alcohol Pad + Safety Blood Lancet + Insert

 

Features

  • Complete kit with all accessories for one step operation
  • One combo card for all IgG, IgM and NS1 test
  • High accuracy over 99.4%
  • Relative Sensitivity 96.7%
  • Relative Specificity 99.9%
  • Read results in 15 minutes

 

Packaging

Box of 10kits, Ctn of 400kits

Dengue NS1 & IgM /IgG Rapid Test Cassette

(Serum/Plasma/Whole Blood)

INTRODUCTION

Dengue viruses,transmitted by the mosquito Aedes aegypti and Aedes albopictus mosquitoes. are widely distributed throughout the tropical and Subtropical areas of the world. There are four known distinct serotypes (dengue virus 1, 2. 3 and 4), In children infection is often subclinical or causes a self-limited febrile disease, However, if the patient is infected second times with a different serotype, a more severe disease. dengue hemorrhagic fever or dengue shock syndrome, is more likely to occur.Dengue is considered to be the most important arthropod-borne viral disease due to the human morbidity and mortality it causes, NS1 is a highly-conserved glycoprotein that is present at high concentrations in the sera of dengue-infected patients during the early 聽clinical phase of the disease.NSl antigen is found from the first day and up to 9 days after onset of fever in sample of primary or secondary dengue infected patients.Usually IgM does not become detectable until 5 to 10 days after the onset of illness in cases of primary dengue infection and until 4 to 5 days aftef onset of illness in secondary infections. In primary infections,IgG appear the 14th day and persist for life, secondary infections show that IgG rise within 1-2 days alter the onset of symptoms and induce IgM response after 20 days of infection.

Dengue NS1&IgM/IgG test cassette is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of NS1,IgM and IgG in human serum (or plasma). The kit is a diagnostic device for qualitative detection .

 

SUMMARY

When a specimen is added to the test, NS1 antigen in the sample react with gold particles聽 labled with dengue antibodies (contain dengue serotypes1, 2. 3 and 4),and IgG and IgM antibodies in the specimen react with gold particles labled with dengue envelope proteins. As this specimen/particle mixture migrates along the length of the test, the dengue NS1, IgG and IgM antibodies particle complex is captured by the relevant NS1,IgG and IgM test bands located in the test device window causing a pale to dark red band to form at the test region of the cassette window. The intensity of the bands will vary depending upon the amount of concentrations present in the sample. The appearance of any color in test region should be considered as positive for NS1,IgG and IgM.A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

 

SPECIMEN COLLECTION

For serum or plasma, collect blood into a container without anticoagulant. If the specimen cannot be tested on the day of collection, store the serum or plasma specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing.

For whole blood specimen, collect fresh blood specimen just prior to using the assay. Specimens must be fresh. Whole blood collected by venipuncture should be stored at 2-8掳C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by finger stick should be tested immediately.

 

TEST PROCEDURE

Open a pouch containing a cassette, remove the test kit from the pouch and place it horizontally onthe desk.

NS1

Dilute the specimen 2 times with diluent(Pipette 1 drop about 25碌l of specimen into the sample well and then add 1 drop about 50碌l of diluent into the same well). Don鈥檛 refer to the scale on the pipette.

IgM and IgG

Dilute the specimen 10 times with diluent(Pipette 1 SMALL drop by refering to the SCALE on the pipette, which is 5碌l of specimen into the sample well and then add 1 drop about 50碌l of diluent into the same well). See picture on the right:

Read results within 15 minutes. Do not read 聽results after 20 minutes.

INTERPRETATION OF RESULTS.

  1. Dengue NS1

Negative: Only control pink band appears on test region of the cassette. This indicates that there is no detectable NS1 antigen in the specimen.

Positive: Two pink bands(C,T) appear on test region of the cassette. This indicates that the specimen contains detectable amount of NS1 antigen.

Invalid: If without colored band appears at control region, this is an indication of a possible error in performing the test. The test should be repeated using a new one.

  1. Dengue IgM and IgG

Negative: Only control pink band appears on C region of the cassette. This indicates that there is no anti-dengue IgM and IgG in the specimen.

Positive: Three pink bands(C,G,M) ,two pink bands(C,G) or(C,M) appear on test region of the cassette. This indicates that the specimen contains detectable amount of anti-dengue IgG and IgM, only IgG, only IgM.

Invalid: If without colored band appears at control region, this is an indication of a possible error in performing the test. The test should be repeated using a new one.

PRECAUTION

1.Must use fresh specimen and avoid repetitive freezing, the result will be invalid

2.Use it before expiry date.

3.The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator. Use the test kit as soon as possible but within 1 hour after removal from pouch specially if the room temperature is more than 30鈩 and in high humidity environment.

4.Old serum can not be used. If the serum is thick, it can be used only after being separated.

 

LIMITATIONS

1.The test is for in-vitro diagnostic use only.

2.The test is qualitative filter detection锛宨t can not be used as the final test for blood donor.

 

STORAGE AND STABILITY

The test kit can be stored at room temperature (18 to 30掳C) in the sealed pouch to the date of expiration. The test kit should be kept away from direct sunlight, moisture and heat.

 

REF.DescriptionCBM/ctnKGS/ctn
L115002Dengue lgG/lgM/NS1 Complete Kit for Whole Blood.聽 Contain one Cassette 4.0mm, dropper, buffer, safety lancet and alcohol pad. Individiual poly bag for each kit.0.0613

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