Progesterone(Prog)Rapid Quantitative Test (Fluorescence Immunoassay)
Ⅰ.Why to choose us?
1. Limits of detection
No higher than 1.40 ng/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 (1.40~ 60.00 ng/mL), the linear correlation
coefficient R≥0.990.
Ⅱ.Components of product
Name | Quantity | Component |
Test cards | 25/40 | It is composed of fluorescent pad (coated with fluorescent labeled
Prog monoclonal antibody and fluorescent labeled biotin),
nitrocellulose membrane (coated with Prog-BSA and GSA), absorbent
paper and backing. |
Sample diluent | 25/40 | Phosphate buffer |
ID card | 1 | With specific stand curve file |
Ⅲ.Intended use of a product
Progesterone(Prog)Rapid Quantitative Test kit is used for
quantitative determination of progesterone in human whole blood,
plasma and serum.
Therefore, the detection of progesterone can be used to determine
ovulation and luteal phase defects. In addition, the detection of
progesterone can also monitor progesterone treatment and evaluate
early pregnancy.
Ⅳ.Test procedure
1. Before the test, please read the instructions completely. If the
test card about Progesterone(Prog)Rapid Quantitative Test kit and
sample are stored in cold storage, they should be balanced at room
temperature (15-30)℃ for not less than 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser and correctly
select the corresponding sample type on the instrument.
3. Take out the ID card, make sure that the batch number of the ID
card is consistent with that of the test card, and insert the ID
card into the ID card port of the instrument.
4. Take out the test card from the aluminum foil bag and use it
within 15 minutes.
5. Place the test card on a clean horizontal table and mark it
horizontally.
6. Mix 100 µL of sample with 200µL of sample diluent. Apply 100 µL
of diluted samples to the well of the test card.
7. At 15 minutes after addition of samples, insert the test card
into NIR-1000 dry fluoroimmunoassay analyser and click the “Instant
test” button to read the results.
Ⅴ.Reference interval
| Gender | Phase | 2.5th percentile (ng/mL) | 97.5th percentile (ng/mL) |
| Male | / | 0 | 1.5 |
| Female | Follicular phase | 0 | 1.9 |
| Ovulatory phase | 0 | 12.0 |
| Luteal phase | 1.7 | 28.7 |
| Menopause | 0 | 1.4 |
| Pregnancy(＜12weeks) | 11.0 | 53.0 |
| Pregnancy(12-24weeks) | 21.5 | 60.0 |
It is strongly recommended that each laboratory should determine
its own normal and abnormal values based on population.
Ⅵ.Prog.pdf
