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Tumor Marker Alpha Fetoprotein AFP Rapid Quantitative Test Kit High Accuracy

Tumor Marker Alpha Fetoprotein AFP Rapid Quantitative Test Kit High Accuracy

Tumor Marker Alpha Fetoprotein Test Kit

High Accuracy Alpha Fetoprotein Test Kit

Human AFP Rapid Test Kit

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ISO13485, CE

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Product Details
Product Name:
AFP Rapid Quantitative Test Kit
Sample Buffer:
25 Vials
12 Months
Applicable Instruments:
NIR-1000 Dry Fluorescent Immunoassay Analyzer
Tumor Marker
Formal Name:
Alpha Fetoprotein
At Room Temperature
Chemiluminescence Immunoassay
Auto Chip Cassette Rapid Test
High Sensitivity, High Accuracy
Supply Capacity:
3 Million A Year
Payment & Shipping Terms
Minimum Order Quantity
US 1.50-2.50 Kit
Packaging Details
Colorful Paper Box
Delivery Time
10 Days
Payment Terms
L/C, T/T
Supply Ability
30000 Kits per Week
Product Description


Alpha Fetoprotein (AFP) Rapid Quantitative Test(Fluorescence immunoassay)

Intended Use

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

Alpha fetoprotein(AFP), the foetal aquivalent to albumin, is a 67kDa glycoprotein produced during embryonic development and found in high concentration in fortal serum and amniotic fluid. In normal non-pregnant adults AFP is present in low concentrations in serum. However AFP may markedly increased in the serum from patients with cancer of the liver, testis or ovary. Quantitative determination of AFP serum may be valuable in the management of patients with suspected or diagnosed liver cancer or germ cell tumors of the testis or ovary.In addition, elevated serum AFP concentration have been measured in patients with other noncancerous,diseases,including ataxia telangiectasia hereditary tyrosinemia neonatal hyperbilirubinemia acuter viral hepatitis, chronic active hepatitis and cirrhosis. Elevated serum AFP concentration are also observed in pregnant woman. Therefore AFP measurement are not recommended for use as a screening procedure to detect the presence of cancer in the general population.

Test procedure

Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity: 20%~90%, Temp: 10℃-50℃) Strip and Cassette: 1. Take off the outer packing, put the strip/cassette onto the desk with the sample adding area of the strip/ the sample window of the cassette up.
2. Drop 3 full drops of serum/plasma/whole blood (approx.80- 100μl) vertically into the sample adding area of the strip/sample hole of the cassette. 3. Observe the test results within 15-20 minutes the result is invalid over 30 minutes.

Result Judgment

POSITIVE: Two distinct red lines appear. A red line in the control region (C), and another red line in the test region (T). A pink to red line (T), even if it is very thin, indicates a positive result. NEGATIVE: A red line appears in the control region(C). No line appears in the test region (T). INVALID: No red lines appear or control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons.Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the kit and contact your local distributor.



Name Quantity Component
Test cards 25 It is composed of fluorescent pad (coated with fluorescent labeled AFP monoclonal antibody), nitrocellulose membrane (coated with AFP monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing
Sample diluent 25(300μL/tube) Phosphate buffer
ID card 1 With specific stand curve file

The components in different batches of kits cannot be used interchangeably.

Storage conditions and validity

The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.

The production date, batch number and expiration date are shown in the outer package of the product.


Applicable instruments

Mod:NIR-1000 Dry Fluoroimmunoassay Analyzer produced by WWHS Biotech.Inc.


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. It is recommended to use serum samples preferentially.

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.



1. Limits of detection No more than 5.0ng /ml.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (5~ 400ng/mL), the linear correlation coefficient R≥0.990.


Tumor Marker Alpha Fetoprotein AFP Rapid Quantitative Test Kit High Accuracy 0


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





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