NSE Rapid Test Kit (Immunochromatographic Assay)

For PROFESSIONAL USE ONLY

 

A. Intended Use

The NSE Rapid Test Kits are used to detect neuron specific enolase (NSE) in human samples,  clinically it is mainly used for auxiliary diagnosis of small cell lung cancer (SCLC) and differential diagnosis of non-small cell lung cancer (NSCLC), monitoring changes in SCLC and neuroblastoma, treatment  response, and monitoring recurrence.

B. Detection Principle

Neuron specific enolase (NSE) is one of the enolases involved in the  glycolytic pathway, present in neural and neuroendocrine tissues.

This kit is an immunochromatographic kit that uses a double antibody  sandwich method to detect AFP in human blood samples.

C. Clinical Significance

High concentrations exist in nerve cells, neuroendocrine cells, and  tumor cells caused by these cells: 

1. Bronchial cancer:

 NSE is considered the preferred biomarker for  detecting small cell bronchial cancer, with 60% -81% of cases showing  elevated NSE concentrations. The concentration of NSE briefly  increases 24-72 hours after the start of the first chemotherapy cycle,  and can last for one week or rapidly decrease at the end of the first  chemotherapy cycle (with an increase in pre-treatment concentration). On the contrary, patients who do not respond to chemotherapy  will have a sustained increase or no decrease in NSE concentration  within the reference range. During the period of remission, 80-96% of  patients have normal NSE concentration, while NSE concentration  increases when the condition recurs. NSE can be used to evaluate the  prognosis, treatment effectiveness, and related etiology of small cell  lung cancer patients: diagnostic sensitivity of 93%, positive predictive  value of 92%. 

2. Neuroblastoma:

 Neuroblastoma is a common solid tumor in  children, originating from the spinal cord and often difficult to  diagnose accurately. 

3. Other tumors:

 In clinical practice, 68% -73% of patients with  seminomas have significantly increased NSE concentrations, which  are practically correlated with the clinical disease process. 22% of non  malignant lung diseases (regardless of tumor stage) have NSE concentrations higher than 25ng/mL. Patients with brain tumors such as  gliomas, spinal cord tumors, neurofibromas, and neuromas may  occasionally have elevated levels of NSE. 

4. Benign diseases: 

Patients with benign lung and brain diseases may  also have elevated serum NSE concentrations (>12ng/mL), such as  diffuse encephalitis, spinal cord and cerebellar degeneration, cerebral  ischemia, cerebral infarction, intracranial blood clots, traumatic brain  injury, schizophrenia, etc.

D. Package Components

(1 Test/Kit)

Specimen: Serum/Plasma/Whole Blood

Please refer to the User Manual for the test process.

Note:

1. Before testing, please carefully read these usage instructions. Only by following all instructions correctly can testing be reliable. 

2. Ensure that the sample loading is appropriate, as results of excessive or insufficient sample loading may be unreliable. 

3. The test results of this reagent kit are for clinical reference only. Doctors should make a final diagnosis by combining various test results and clinical symptoms. 

4. The result may be interfered by HAAA (human anti animal antibody), heterophilic antibody, self analyte antibody, rheumatoid factor, and other proteins such as hormone binding proteins in the blood of patient.

E. Storage Conditions and Shelf Life

1. Storage Condition: A dry and dark place at 2-30 ℃.

2. Shelf Life: 2 years and should not be frozen. 

3.The reagent should be used as  soon as possible within 1 hour after opening the aluminum foil bag.

When the ambient temperature is above 30 ℃ or the humidity is high,  it is recommended to use the reagent as soon as possible.

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