WWHS NSE FIA POCT Rapid Quantitative Test Kit 25T Assay
Applications
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
Characteristics
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 |
| 20 | AFP | Serum/Plasma | 15min. | 2.5-200ng/ml | <20ng/ml | pregnancy cancer |
| 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 |
| 26 | TPSA | Serum/Plasma | 15min. | 0.5-40ng/ml | <4ng/ml | prostate cancer |
| 27 | FPSA | Serum/Plasma | 15min. | 0.1-10ng/ml | <1ng/ml | prostate cancer |
| 28 | CA12-5 | Serum/Plasma | 15min. | 20-500U/ml | <35U/ml | ovarian cancer |
| 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.
Quality Control
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.
