Whole Blood p24 Hiv Antigen Test One Step Medical Diagnostic Test Kit

• 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

Instruction for Use

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 clinical phase of the disease.NS1 antigen is found from the first day and up to 9 days after onset of fever in a 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 after onset of illness in secondary infections. In primary infections, IgG appears the 14th day and persist for life, secondary infections show that IgG rises within 1-2 days after 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 labeled with dengue antibodies (contain dengue serotypes1, 2. 3 and 4), and IgG and IgM antibodies in the specimen react with gold particles labeled 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 the dark red band to format the test region of the cassette window. The intensity of the bands will vary depending upon the number of concentrations present in the sample. The appearance of any color in the 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°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 on the desk.