Diagnostic Kit for P24 Antigen to Human Immunodeficiency Virus
Diagnostic Kit for P24 Antigen to Human Immunodeficiency Virus
(Fluorescence Immunochromatomatographic Assay)
Production information
| Model Number | P24 | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic Kit for P24 Antigen to Human Immunodeficiency Virus |
Instrument classification | Class III |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | (Fluorescence Immunochromatomatographic Assay) | OEM/ODM service | Avaliable |
Test procedure
| 1 | Open the aluminum foil bag package of reagent, and take out the test device; |
| 2 | Horizontally insert the test device into the slot of immune analyzer; |
| 3 | On home page of operation interface of immune analyzer, click “Standard” to enter test interface; |
| 4 | Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument, and select sample type; |
| 5 | Check the consistency of “Product Name”, “Batch Number” and etc. on test interface with information on the kit label; |
| 6 | After information consistency is confirmed, take out sample diluents, add 80µL of serum sample, and sufficiently mix; |
| 7 | Add 80µL of above mixed solution into the sample hole of test device; |
| 8 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 9 | Immune analyzer will automatically complete test and analysis when test time is reached. |
Intend Use
This kit is suitable for the in vitro quantitative detection of human immunodeficiency virus antigen (p24) in human serum sample as an aid in the diagnosis of human immunodeficiency virus infection. This kit provides results for the detection of human immunodeficiency virus antigen (p24) only and the obtained result shall be analyzed in combination with other clinical information.
Summary
Human Immunodeficiency Virus (HIV) belongs to the genus Lentivirus in the family Retroviridae and is the causative agent of Acquired Immuno deficiency Syndrome (AIDS), which is classified into type 1 and type 2 depending on the genetic origin of the virus. Type 1 and type 2 are classified according to the genetic origin of the virus. The main transmission routes of HIV are sexual contact transmission, blood transmission and mother-to-child transmission. 1-2 weeks after HIV infection, the first viral marker in the blood is the core protein p24.
Feature:
• High sensitive
• result reading in 15 minutes
• Easy operation
• Factory direct price
• Do not need extra machine for result reading
Clinical performance
Clinical evaluation performance of the product is assessed through collecting 330 clinical samples. The corresponding kit of listed electrochemiluminescence method is used as the control reagent. The test results are compared, and their comparability is studied with linearity regression. The correlation coefficients of the two tests are Y=0998X+0.380 and R=0.9889, respectively.
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