Getein Biotech Estradiol Fast Test Kit Instruction Manual

Biotech Estradiol Fast Test Kit
Instruction Manual

INTENDED USE

Estradiol Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of estradiol in human serum and plasma. Estradiol tests are used to measure ovarian function. For professional and laboratory use.
SUMMARY
Estradiol is a kind of steroid hormone, which is the most important and biologically active hormone in estrogen. For non-pregnant women, it is mainly secreted by ovarian follicles and corpus luteum; The adrenal cortex and male testicular interstitial cells can also produce a small amount of estradiol, which is mainly produced by the placenta in pregnant women.
The concentration of estradiol in the blood changes during the menstrual cycle. Most circulating estradiol combines with sex hormone binding globulin or albumin, and about 1-3% of estradiol is free. Estradiol plays an indispensable role in the development of reproductive organs and secondary sexual characteristics. Estradiol determination can monitor ovarian function and is a very useful indicator for evaluating various menstrual abnormalities. It has a high guiding significance in analyzing sexual development, causes of amenorrhea, infertility and menopause; Dynamic monitoring of estradiol level is helpful to monitor ovulation, because estradiol level reflects the maturity of follicles; when female sexual precocity occurs, estradiol levels are often higher than normal; Continuous and dynamic detection of estradiol can also be used to monitor fetal placental function during pregnancy.
PRINCIPLE
Estradiol Fast Test Kit (Immunofluorescence Assay) is a lateral flow immunoassay in a competitive design. After the sample has been applied to the test strip, the fluorescence latex-labelled estradiol monoclonal antibody binds with the estradiol in sample and forms a marked antigen-antibody complex. The uncombined fluorescence latex-labelled estradiol monoclonal antibody binds with the estradiol on the test line.
The fluorescence intensity of the test line decreases in proportion to the amount of estradiol in sample. Fluorescent signals intensity can be analyzed by applicable device thus the estradiol in sample be detected quantitatively.
APPLICABLE DEVICE

• Getein 1100 Immunofluorescence Quantitative Analyzer
• Getein 1160 Immunofluorescence Quantitative Analyzer
• Getein 1180 Immunofluorescence Quantitative Analyzer

CONTENTS

Estradiol
test card| 10 pcs| 25 pcs
Disposable
pipet| 10 pcs| 25 pcs
Sample
diluent| 10 tube| 25 tube
User
manual| 1 pc| 1 pc
SD card| 1 pc| 1 pc

Sample diluent for Getein 1100/ Getein 1160/ Getein 1180 consists of:
Sample diluent contains 3-Morpholinepropanesulfonic acid buffer (50 mmol/L), ProClin TM 300 (0.1%).
A test card consists of:
Fluorescence latex-labelled estradiol monoclonal antibody, Fluorescence latex- labelled Chicken immunoglobulin Y natural protein ，estradiol antigen and Goat anti chicken immunoglobulin Y polyclonal antibody.
Note:

1. The standard curve data can be written to RFID card in the kit. According to the function of RFID card, we define it as “Standard Curve Data Card”, short for “SD Card”.
2. Do not mix or interchange different batches of kits.

STORAGE AND STABILITY
Realtime stability:
Store the kit at 4~30°C with a valid period of 24 months. The test kits are stable until the expiry date printed on the labels.
In-use stability:
For the test card of Gethin 1100/Gethin 1160/Gethin 1180: Use
the test card within 1 hour once the foil pouch is opened.

PRECAUTIONS

1. For in vitro diagnostic use only.
2. Handle all specimens as potentially infectious. The foil bag is nondegradable. Proper handling and disposal methods should be followed in accordance with local regulations.

SPECIMEN COLLECTION AND PREPARATION

1. This test can be used for plasma and serum samples.
2. Heparin, sodium citrate or EDTA can be used as the anticoagulant for plasma samples.
3. It is recommended to test the sample within 8 hours after collection. Stable in plasma and serum for 2 days when stored at 2~8°C and 3 months when stored at -20°C.
4. Refrigerated or frozen sample should reach room temperature before testing. Avoid multiple freeze-thaw cycles.

CALIBRATION

1. Calibration: The regression equation fitting the concentration value of the working calibrator with the reaction signal value is written into the SD card in advance. Before detection, the
   SD card is written into the instrument, which can automatically read the calibration curve information in the SD card.
   During detection, the content of analyte can be calculated by substituting the obtained signal value into the regression equation.

Calibration Frequency: A new calibration is required when using a new reagent lot or a new instrument.
TEST PROCEDURE

1. Before use, you must carefully read the instructions for use and operate in strict accordance with the instructions, otherwise reliable results cannot be guaranteed.

2. Test kit and sample should be brought to room temperature before testing.

3. Confirm SD card lot No. in accordance with test kit lot No. Perform calibration using the SD card when necessary.

4. Select the corresponding model on the analyzer according to the sample type (see the instructions of analyzer for details).

5. Remove the test card from the sealed pouch before use. Horizontally place the test card.

6. Deliver 100 μL of sample into one tube of sample diluent using disposable pipet, mix gently and thoroughly. (Samples must be added using the disposable pipet in the kit
   to avoid incorrect results). Note 1: Press the top of the disposable pipet to the bottom with your finger during sampling. Ensure that the slit is fully submerged in the sample.
   Note 2: Thoroughly press the disposable pipette only once to take a sample, not repeatedly.

7. Insert the disposable pipet into the sample diluent tube to mix the sample by pushing the cap at the top of the disposable pipet for 4-6 times and wait 5~10 minutes.
   Note 3 ：Insert the disposable pipet to the bottom of tube to prevent bubbles.
   Note 4 ：It is recommended to wait for 5-10 minutes after mixing the samples, and the results of early or overtime testing are inaccurate.

8. Deliver the sample mixture by pushing the cap at the top of the disposable pipet and dispense the sample mixture into the sample port “S” on the test card.

For Gethin 1100:
Reaction time: 15 minutes. Insert the test card into Gethin 1100 and press “ENT” button (click on “Start” icon for Android Getein 1100) after reaction time is elapsed. The  exult will be shown on the screen and printed automatically.
For Getein 1160/Getein 1180:
Insert the test card into Gethin 1160/Gethin 1180 immediately after sample loading. The analyzer will count down the reaction time (15 minutes) and automatically test the  ard after reaction time is elapsed. The result will be shown on the screen and printed automatically.
RESULTS
Getein1100/Getein1160/Getein1180 can scan the test card automatically and display the result on the screen. For additional information, please refer to the user manual of Getein1100/Getein1160/ Getein1180.
Estradiol Fast Test Kit (Immunofluorescence Assay) results are provided in pg/Mr.
Results in pg/mL may be converted to pool/mL as shown with an example below.
Estradiol Fast Test Kit (Immunofluorescence Assay) result as reported by the system (example) 1.0 pg/mL
The reported example results equal: 3.67pmol/mL Others: Measuring range of the Estradiol Fast Test Kit is 40.0 ~ 4800.0 pg/mL. Samples initially outside the measuring range may be diluted with 1% bovine serum albumin, measuring range can be up to 12000 pg/mL through dilution.
PERFORMANCE CHARACTERISTICS

LIMITATIONS

1. The test results of this kit are only for clinical reference and cannot be used as the basis for confirming or excluding cases alone. In order to achieve the purpose of diagnosis, this test result should be used in combination with clinical examination, medical history and other examination results.

2. Do not use the test card if the foil pouch or the cartridge is damaged.

3. Do not open pouches until performing the test.

4. Patient samples may contain heterophilic antibodies (e.g. human anti-mouse antibodies (HAMA) and rheumatoid factors) that could react in immunoassays to give a falsely elevated or depressed result. This assay has been designed to minimize interference from heterophilic antibodies.
   Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.

5. Triglyceride and bilirubin in the sample may interfere with the test results, and the maximum allowable concentrations are 18 g/L and 0.1 g/L respectively.

EXPECTED VALUE
The expected normal value for Estradiol was determined by testing samples from apparently healthy individuals. Reference range of estradiol:

Healthy
women| Metaphaseof follicle| 112| <40-126
Metaphase luteum| 98| 50-290
Ovulation cycle| 102| 95-432
Postmenopausal
women| 136| <40

Expected values may vary with age, sex, sample type, diet and geographical location. Each laboratory should verify the transferability of the expected values to its own population, and if necessary, determine its own expected values according to good laboratory practice.

REFERENCES

1. Caldwell JD, Gebhardt VM, Jinrikisha GF. Estradiol’s interesting life at the cell’s plasma membrane. Steroids. 2016; 111:4-11.
2. Pfaff DW, Magnitude K, Hunter RG. Molecular endocrinology of female reproductive behavior. Mold Cell Endocrinol. 2018; 467:14-20.
3. Yen, S S C, The Human Menstrual Cycle: Neuroendocrine regulation. In Reproductive Endocrinology. Edited by Yen, S S C and Jaffe, R B Philadelphia ，PA:W B Saunders Co.1911,273-308.
4. Kumar A, Banerjee A, Singh D, et al. Estradiol: A Steroid with Multiple Facets. Horn Me tab Res. 2018;50(5):359-374.
5.  Hall JE. Polycystic ovarian disease as a neuroendocrine disorder of the female reproductive axis. Endocrinol Me tab CLIN North Am. 1993;22(1):75-92.6. EN ISO 18113-1:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements.
6. EN ISO 18113-2:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use.

DESCRIPTION OF SYMBOLS USED
The following graphical symbols used in or found on Estradiol Fast Test Kit (Immunofluorescence Assay) are the most common ones appearing on medical devices and their
packaging. They are explained in more details in the European Standard EN ISO 15223-1:2021.

Key to symbols used

| Manufacturer| | Use-by date
| Do not re-use| | Date of manufacture
| Consult instructions for use or consult electronic
instructions for use| | Batch code
| Temperature limit| | In vitro diagnostic  medical device
| Contains sufficient for tests| | Authorized representative in the European
Community/European Union
| CE mark| | Do not use if package is damaged and consult
instructions for use
| Catalogue number| | Keep dry
| Keep away from sunlight| | Caution

Thank you for using Estradiol Fast Test Kit (Immunofluorescence Assay). Please read this user manual carefully  before operating  to ensure proper use. Please report any product problems or adverse events to the below manufacture or authorized representative in the European Community in time.
Document no.:
Version: WIF81-S-03
Effective date: 2023.03.02

Gethin Biotech, Inc.
Add.: No.9 Bomu Road, Lute District, Nanjing, 211505, China
Tel: +86-25-68568508
Fax: +86-25-68568500
E-mail: tech@getein.com.cn
overseas@getein.com.cn
Website: www.getein.com
CMC Medical Devices & Drugs S.L.
Add.: C/ Horacio Lingo Nº 18, CP 29006, Málaga,
Spain
Tel: +34951214054

References

• COVID-19 Testing Solution,Point-of-Care Testing,Blood Test Analyzer

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