Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO13485, CE
Model Number:
AFP
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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.
Components
| 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.
Performance
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.
produce.AFP.pdf
| 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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