Estradiol (E2) Rapid Quantitative Test (Fluorescence Immunoassay)
Ⅰ.Intended use of the product
Estradiol (E2) Rapid Quantitative Test kit is used for quantitative
determination of estradiol in human whole blood, plasma and serum.
The increase of estradiol was found in multiple pregnancy, ovarian
cancer, systemic lupus erythematosus and so on. In men, if there is
feminization syndrome, breast feminization and testicular cancer,
estradiol will also increase. The decrease of estradiol can be seen
in pregnancy induced hypertension syndrome, ovarian cyst,
hydatidiform mole, pituitary ovarian infertility and so on.
Ⅱ.Principle of product Testing
Estradiol (E2) Rapid Quantitative Test kit adopts the principle of
competitive method. Take the sample to be tested, add it into the
sample diluent and mix it evenly. Add the mixed sample into the
sample adding hole. E2 in the sample combines with the fluorescent
labeled antibody on the binding pad to form a complex. Under the
action of chromatography, the complex moves forward along the
nitrocellulose membrane, and the fluorescent labeled antibody that
does not bind to the Estradiol (E2) Rapid Quantitative Test line is
captured by E2-BSA coated on the nitrocellulose membrane detection
line. The more E2 in the sample, the fewer complexes gathered on
the detection line, and the signal of fluorescent antibody is
inversely proportional to the number of objects to be tested in the
sample. The quantitative detection results were obtained by
NIR-1000 dry fluoroimmunoassay analyser.
Ⅲ.Components of a product
| Name | Quantity | Component |
| Test cards | 25/40 | It is composed of fluorescent pad (coated with fluorescent labeled
E2-BSA and fluorescent labeled biotin), nitrocellulose membrane
(coated with goat anti mouse IgG antibody and GSA), absorbent paper
and backing. |
| E2 antibody lyophilized powder | 25/40 | Mouse anti E2 antibody (lyophilized) |
| Sample diluent | 25/40 | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
Ⅳ.Test procedure
1. Before the test, please read the instructions completely. If the
Estradiol (E2) Rapid Quantitative Test card 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 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. Add 90µL sample diluent to the tube containing fluorescent
lyophilized powder. One tube is used by one test.
7. Add 30 µL sample to the tube, mix the solution thoroughly and
keep incubation for 5 minutes.
8. Apply 100 µL incubated sample to the well of the test card.
9. At 15 minutes after addition of incubated sample, insert the
test card into dry fluorescent immunoanalyzer, read and record the
results then dispose of used test appropriately.
Ⅴ.Reference interval
| Gender | Phase | Age | 2.5th percentile (pg/mL) | 97.5th percentile (pg/mL) |
| Male | / | 18-70 | <9.0 | 85 |
| Female | Follicular phase | 18-45 | 12 | 262 |
| Ovulatory phase | 18-45 | 40 | 396 |
| Luteal phase | 18-45 | 21 | 381 |
| Menopause | 46-70 | <9.0 | 190 |
| Early pregnancy | 22-42 | 145 | 2988 |
| Second trimester | 21-38 | 1502 | >3000 |
Ⅵ. E2.pdf
