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ISO 13485, CE
WWHS NSE FIA POCT Rapid Quantitative Test Kit 25T Assay
Tumor marker in tumors of neuroectodermic or neuroendocrine origin
Evaluation of prognosis in small-cell lung cancer and follow-up of cytotoxic treatment
Differential diagnosis between Wilms tumor and neuroblastoma in presence of abdominal mass syndrome
Prognostic factor in neuroblastoma
Surveillance of neuroblastoma
1. Accurate: Double antibody sandwich method, high sensitivity.
2. Rapid: Get results in 10 minutes.
3. Convenient: No need professional training, test could be performed at any time, any place.
Importance of IVD
The importance of in vitro diagnosis in life and health is mainly reflected in that no matter healthy people, asymptomatic and symptomatic people and people with chronic diseases are inseparable from diagnostics, and diagnosis runs through the whole medical cycle. In particular, modern medicine has entered the era of precision medicine, and the core of precision medicine is accurate diagnosis.
|Assay List||Tumor Maker|
|cat#.||Product Item||Specimen||Reaction Time||Measure Range||Clinical Range||Intended Use|
|21||CEA||Serum/Plasma||15min.||1-200ng/ml||<5ng/ml||colon cancer, colorectal cancer,etc.|
|22||NSE||Serum/Plasma||15min.||1-400ng/ml||<16ng/ml||non-small cell lung cancer|
|23||FOB||fecal specimens||10min.||50-1000ng/ml||<100ng/ml||Abnormal recessive gastrointestinal bleeding|
|24||PG II||Serum/Plasma||15min.||1-100ug/L||PGI/PGII>3.0||gastric abnormalities|
|25||PG I||Serum/Plasma||15min.||2.5-200ug/L||>70ng/ml||gastric abnormalities|
|29||CA15-3||Serum/Plasma||15min.||10-400U/ml||< 25 U/mL||breast cancer|
|30||HE4||Serum/Plasma||15min.||50-2000pmol/L||<140 pmol/L||ovarian cancer|
|31||CA19-9||Serum/Plasma||15min.||10-400U/ml||< 27 U/mL||pancreatic cancer|
|32||β-HCG||Serum/Plasma||15min.||5-400mIU/ml||<10 mIU/mL||Early pregrancy, ectopic HCG cancer,incomplete abortion|
|33||CK19(Cyfra21-1)||Serum/Plasma||15min.||0.5-50ng/ml||<2.5ng/ml||non-small cell lung cancer|
Interpretation of Test Results
1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
2. For samples whose cTnI concentration is lower than 0.1ng/mL and higher than 40ng/mL, test result is “＜0.1ng/mL” and “＞40ng/mL” respectively.
A procedural control is included in the test. A colored line appearing in the control region (C) is the internal procedural
control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that a positive control and a negative control control be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
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