Type: | Test Strips & Test Tube |
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Ethylene Oxide Sterilization: | Ethylene Oxide Sterilization |
Quality Guarantee Period: | Two Years |
Group: | All |
Logo Printing: | Without Logo Printing |
Certification: | CE, ISO13485 |
Customization: |
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1.easy to use
2.easy to read
3.High accuracy
4.High speed
Product principle:
AFP is a tumor marker. It is generated by yolk sac and embryonic liver normally, keeps a low level after a year of birth, elevates in liver disease, and significantly increases in hepatocellular carcinoma and teratoma. It has been a conventional indicator for the clinical diagnosis of primary liver cancer. This product detects antigens in blood, serum and plasma using immune colloidal gold technology and double antibody sandwich method. In detection, if the sample contains AFP, it will react with label to form complex, under the effect of chromatography, the reaction complex moves forward to the detecting area along the nitrocellulose membrane and is captured by AFP-specific antibody on the nitrocellulose membrane, and finally form a red reaction line in the detecting area, the results are positive this moment. If the sample does not contain AFP or AFP level is lower than the minimum detectable quantity, the red line will not appear in the detecting area, and the results are negative this moment.
Indicators of product technical characteristics:
1. Minimum detectable quantity: ≥ 25ng/ml
2. Sensitivity and specificity: No cross reaction occurs in the detection of AIDS-, hepatitis C-, HBsAg-, Chlamydia- and syphilis-positive samples.
Technical indicators:
Statistical results of Egens reagent on 310 samples
Egens reagent |
Control reagent kit |
Total |
|
Positive |
Negative |
||
Positive |
88 |
2 |
90 |
Negative |
1 |
219 |
220 |
Total |
89 |
221 |
310 |
Sensitivity: Se=98.88%
Specificity: Sp=99.10%
False positive rate=0.90%
False negative rate =1.12%
Total accordance rate = 99.03%
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