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HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD

HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD

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Product Details
Product Name:
HE4 Rapid Quantitative Test Cassette
Sample Buffer:
25 Vials
12 Months
Applicable Instruments:
NIR-1000 Dry Fluorescent Immunoassay Analyzer
WWHS Biotech INC
Tumor Marker
Sample Type:
Serum / Plasma
High Sensitivity
Annual Capacity:
3 Million A Year
Payment & Shipping Terms
Minimum Order Quantity
Packaging Details
Colorful Paper Box
Delivery Time
10 Days
Payment Terms
L/C, T/T
Supply Ability
20000 Kits per Week
Product Description

HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD


Product name

Human Epididymal protein (HE4) Rapid Quantitative Test(Fluorescence immunoassay)


Package specification

25 Tests/kit


Intended use

This kit is used for quantitative determination of HE4 in human whole blood, plasma and serum.

HE4 is a secretory glycoprotein with a molecular weight of 25 kDa. It belongs to the whey acidic protein family. Because its structure contains four disulfide bond core regions of whey acidic protein, it is also called wfdc2. HE4 is expressed in a variety of epithelial cells, including respiratory epithelial cells, salivary gland mucus cells, breast ductal epithelium, distal tubular epithelial cells and epididymal epithelial cells. HE4 plays a role in innate immunity and may also be a tumor marker of ovarian cancer.


Test principle

The HE4 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of HE4. The HE4 antigen in the sample was first bound with the conjugated compound of fluorescent labeled HE4 monoclonal antibody, then moved and combined with another HE4 monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyzer.


Sample requirements

1. Plasma, serum and whole blood can be used as samples. The whole blood should be collected in a tube containing heparin, citrate or EDTA as the anticoagulant. If the serum procedure is used, collect blood in a tube without anticoagulant and allow clotting. Hemolyzed samples should not be used.
2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 24 hours. Plasma and serum samples can be stored at 2℃~ 8℃ for 7 days, -20℃for 30 days.
4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided.


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.


WWHS POCT Assay List


 Tumor Marker          
cat#. Product Item Specimen Reaction Time Measure Range Clinical Range Intended Use
18 AFP Serum/Plasma 15min. 2.5-200ng/ml <20ng/ml pregnancy cancer
19 CEA Serum/Plasma 15min. 1-200ng/ml <5ng/ml colon cancer, colorectal cancer,etc.
20 NSE Serum/Plasma 15min. 1-400ng/ml <16ng/ml non-small cell lung cancer
21 FOB fecal specimens 10min. 50-1000ng/ml <100ng/ml Abnormal recessive gastrointestinal bleeding
22 PG II Serum/Plasma 15min. 1-100ug/L PGI/PGII>3.0 gastric abnormalities
23 PG I Serum/Plasma 15min. 2.5-200ug/L >70ng/ml gastric abnormalities
24 PSA Serum/Plasma 15min. 0.5-40ng/ml <4ng/ml prostate cancer
25 FPSA Serum/Plasma 15min. 0.1-10ng/ml <1ng/ml prostate cancer
26 CA12-5 Serum/Plasma 15min. 20-500U/ml <35U/ml ovarian cancer
27 CA15-3 Serum/Plasma 15min. 10-400U/ml < 25 U/mL breast cancer
28 HE4 Serum/Plasma 15min. 50-2000pmol/L <140 pmol/L ovarian cancer
29 CA19-9 Serum/Plasma 15min. 10-400U/ml < 27 U/mL pancreatic cancer
30 β-HCG Serum/Plasma 15min. 5-400mIU/ml <10 mIU/mL Early pregrancy, ectopic HCG cancer,incomplete abortion
31 CK19(Cyfra21-1) Serum/Plasma 15min. 0.5-50ng/ml <2.5ng/ml non-small cell lung cancer


HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD 0



HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD 1HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD 2HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD 3HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD 4HE4 Rapid Quantitative Fluorescence Immunoassay Test Cassette FIA POCT IVD 5


Interpretation of results

1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and higher than 200ng/ml, the detection results are reported as "< 2.5ng/ml" and "> 200ng /ml", respectively.

Limitations of methods

1. This kit is only used to detect human plasma/whole blood samples
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than 20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the relative deviation of the test results is within ±15%.

Applicable Instrument


WWHS NIR-1000 dry fluoroimmunoassay analyser



1.How to buy your products? Do you have distributor in our country?

You can buy the products from our company directly.Normally the procedure is:Sign the contact ,payment byT/T, contact the shipping company to delivery the goods to your country.


2. What is the warranty?

The free warranty is one year from the day of Commissioning qualified.


3.Can we visit your country?

Of course,we will prepare for everything in advance if it is necessary .Generally,it is require that customers must have build agency relationship or business relationship with our company.


4.How long is the validity of quotation?

Generally,our price is valid within one month from the date of quotation .The price will be adjusted appropriately according to the price fluctuation of raw material and changes in market.


5.Do you have the CE certificate?

Yes, most of our products have the CE certificate.


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