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Product info
- Product name:Fluorescence Immunoassay Rapid Quantitative Test Machine
- Product code:CCL-FS113
Packaging Specifications
- Outer Packaging Size:0 × 0 × 0 m
- Gross Weight:0 kg
- Net Weight:0 kg
- Volume:0
Description
Test Panel Overview
Tumor Markers
表格
| Test | Indication | Specimen | Time | Range | Cutoff | Cert |
|---|---|---|---|---|---|---|
| AFP | Liver Cancer | Serum/Plasma | 15 min | 5–400 ng/mL | 0–20 ng/mL | CE |
| PSA | Prostate Cancer | Serum/Plasma | 15 min | 2–100 ng/mL | 0–4 ng/mL | CE |
| CEA | Cancer | WB/Serum/Plasma | 15 min | 1–500 ng/mL | 0–5 ng/mL | CE |
| fPSA | Prostate Cancer | WB/Serum/Plasma | 15 min | 0.2–30 ng/mL | < 1 ng/mL | CE |
Diabetes & Renal Injury
表格
| Test | Indication | Specimen | Time | Range | Cutoff | Cert |
|---|---|---|---|---|---|---|
| HbA1c | Diabetes Mellitus | WB | 5 min | 4.0–14.5% | 4–6% | CE, CFDA |
| MAU | Renal Injury | Urine | 3 min | 5–300 mg/L | 0–20 mg/L | CE, CFDA |
| CysC | Renal Injury | WB/Serum/Plasma | 5 min | 0.2–10 mg/L | 0.5–1.1 mg/L | CE, CFDA |
| NGAL | Renal Injury | Urine | 15 min | 10–1500 ng/mL | ≤131.7 ng/mL | CE, CFDA, IFCC, NGSP |
| β2-MG | Proximal Renal Tubule Dysfunction | WB/Serum/Plasma | 10 min | 0.3–20 mg/L | 1.0–2.7 mg/L | CE |
Fertility
表格
| Test | Indication | Specimen | Time | Range | Cutoff | Cert |
|---|---|---|---|---|---|---|
| β-hCG | Fertility | WB/Serum/Plasma | 15 min | 2–200,000 mIU/mL | 5 mIU/mL | CE, CFDA |
| LH | Fertility | WB/Serum/Plasma | 15 min | 1–100 mIU/mL | Female: 1.70–8.60 mIU/mL; Male: 2.95–95.75 mIU/mL | CE |
| FSH | Fertility | WB/Serum/Plasma | 15 min | 1–100 mIU/mL | Female: 1.70–8.60 mIU/mL; Male: 2.95–95.75 mIU/mL | CE |
| Prog | Fertility | WB/Serum/Plasma | 15 min | 1.5–60 ng/mL | Female: 1.70–8.60 mIU/mL; Male: 2.95–95.75 mIU/mL | CE |
| PRL | Fertility | WB/Serum/Plasma | 15 min | 1–200 ng/mL | Female: 1.70–8.60 mIU/mL; Male: 2.95–95.75 mIU/mL | — |
Thyroid Hormone
表格
| Test | Indication | Specimen | Time | Range | Cutoff | Cert |
|---|---|---|---|---|---|---|
| T3 | Thyroid Malfunction | WB/Serum/Plasma | 15 min | 0.61–9.22 nmol/L | 1.3–3.1 nmol/L | CE |
| T4 | Thyroid Malfunction | WB/Serum/Plasma | 15 min | 12.87–300 nmol/L | 66–181 nmol/L | CE |
| TSH | Thyroid Malfunction | WB/Serum/Plasma | 15 min | 0.1–100 mIU/L | 0.3–4.2 mIU/L | CE |
Full Test Menu Summary
- Fertility: β-HCG, LH, FSH, PRL, Prog
- Infection: PCT, CRP (hsCRP+CRP), 2 in 1 (CRP+PCT), SAA
- Cardiac: NT-proBNP, cTnI, Myo, CK-MB, H-FABP, 3 in 1 (cTnI + Myo + CK-MB), 2 in 1 (cTnI+NT-ProBNP), BNP
- Diabetes & Renal Injury: HbA1c, MAU, CysC, NGAL, β2-MG
- Tumor: AFP, PSA, CEA, fPSA
- Coagulation: D-Dimer
- Thyroid Hormone: T3, T4, TSH
- Ongoing: Vitamin-D, S100β, ST2, T, E2
Test Principle & Operation
Principle
The test is based on the lateral flow immunoassay combined with time-resolved fluorescence (TRFIA) technology:
- Sample mixing: The specimen is mixed with buffer.
- Immunoreaction: Analyte in the sample binds to fluorescent-labeled antibodies on the test strip.
- Detection: The instrument reads the fluorescence signal and calculates the concentration based on a calibration curve.
Step-by-Step Operation
- Sampling: Collect the specimen.
- Mixing: Mix the sample with the provided buffer.
- Dropping: Add the mixture to the sample well of the test strip.
- Reading: Insert the strip into the analyzer for automatic detection.
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