β-HCG Test Cassette,with high sensitivity, quantitative
determination β- HCG,Fluorescence Immunoassay Test
Application
The β-hCG Test Cassette is intended for in vitro quantitative
determination β-human chorionic gonadotropin (β-hCG) in serum or
plasma as an aid in the diagnosis of menopause.The test result is
calculated by Fluorescence Immunoassay Analyzer.
| Product Name: | β-HCG Test Cassette,with High Sensitivity, Quantitative
Determination β- HCG,Fluorescence Immunoassay Test |
| Format: | Cassette |
| Certificate: | CE |
| Pack: | 10T/25T |
| Shelf Life: | 24 Months |
| Linearity Range: | 5-10000 MIU/mL, R≥0.990 |
| Principle: | Fluorescence Immunoassay |
| Specimen: | S/P |
| Reading Time: | 15 Minutes |
| Storage Temperature: | 4-30℃ |
| Cut-Off: | 25mIU/mL |
| Detection Range: | 5-10000 MIU/mL |
Description:
Human chorionic gonadotropin (hCG) is a glycoprotein hormone
produced by the developing placenta shortly after fertilization. In
normal pregnancy, hCG can be detected in both urine and serum or
plasma as early as 7 to 10 days after conception.1,2,3,4hCG levels
continue to rise very rapidly, frequently exceeding 100mIU/ml by
the first missed menstrual period,2,3,4 and peaking in the
100,000-200,000mIU/ml range about 10-12 weeks into pregnancy. The
appearance of hCG in both the urine and serum or plasma soon after
conception, and its subsequent rapid rise in concentration during
early gestational growth, make it an excellent marker for the early
detection of pregnancy.
The hCG Pregnancy Rapid Test Cassette is a rapid test that
qualitatively detects the presence of hCG in urine specimen at the
sensitivity of 20mIU/ml. The test utilizes a combination of
monoclonal and polyclonal antibodies to selectively detect elevated
levels of hCG in urine. At the level of claimed sensitivity, the
hCG Pregnancy Rapid Test Cassette shows no cross reactivity
interference from the structurally related glycoprotein hormones
hFSH, hLH and hTSH at high physiological levels.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE: Two distinct colored lines appear. One line should be in the control line region (C) and another line
should be in the test line region (T). One line may be lighter than
the other; they do not have to match. This means that you are
probably pregnant.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). This means that you
are probably not pregnant.
INVALID: The result is invalid if no colored line appears in the control
line region (C), even if a line appears in the test line region
(T). You should repeat the test with a new test cassette.
PRODUCT FEATURES
【PERFORMANCE CHARACTERISTICS】 1. Accuracy The test deviation is ≤±15%. 2. Sensitivity The β-hCG Test Cassette can detect levels of β-hCG as low as 5mIU/mL in serum or plasma. 3. Detection range 5-10000 mIU/mL 4. Linearity range 5-10000 mIU/mL, R≥0.990 |
Fast Result (15 minutes) Simple Operation (Less Training Required) Objective (Results Read by Analyzer) Stringent Quality Control Insure High Accuracy User-friendly (Simple Plug & Play Operation) High Efficiency (Both STAT Testing and Batch Testing) |
