Progest/erone(P4) Test Cassette (Serum /Plasma) is based on Fluorescence
Immunoassay for the quantitative determination of Progest/erone in serum, plasma by
auxiliary diagnosis of threatened abortion in clinical.
【SUMMARY】
Progeste/rone also known as P4 (pregn-4-ene-3, 20-dione) is a C-21 hormone
involved in the female menstrual cycle, pregnancy (supports gestation) and
embryogenesis of humans and other species.[1]
Progester/one is essential for the regulation of normal female reproductive functions. The
major physiological actions of progest/erone are: a) in the uterus and ovary: induction of
ovulation, facilitation of implantation, and maintenance of early pregnancy; b) in the
mammary gland: lobular-alveolar development in preparation for milk secretion; c) in the
brain: neurobehavioral expression associated with responsiveness and d) in the
bone: prevention of bone loss[2] .
During the follicular phase of the cycle, levels remain low.[3] Following the LH
surge and ovulation, luteal cells in the ruptured follicle produce proge/sterone in response
to LH. During this, the luteal phase, proges/terone rises rapidly to a maximum of 10-20
ng/mL at day following ovulation. During the luteal phase, progeste/rone transforms the
estro/gen-primed endometrium from a proliferative to a secretory state. If pregnancy does
not occur, progest/erone levels decrease during the last four days of the cycle due to the
regression of the corpus luteum.[3] If conception occurs, the levels of progest/erone are
maintained at mid-luteal levels by the corpus luteum until about week six. At that time the
placenta becomes the main source of proge/sterone and levels rise from approximately
10-50 ng/mL in the first trimester to approximately 50-280 ng/mL in the third trimester.[3,4,5]
【PRINCIPLE】
The Progestero/ne(P4) Test Cassette (Serum /Plasma) detects progest/erone based on
Fluorescence Immunoassay. The specimen moves through the strip from sample pad to
absorbent pad. Progeste/rone in the specimen will compete with the Pro/gestero/ne antigen
coated on the membrane with the progestero/ne antibody labeled with fluorescent
microspheres. The less Progest/erone in the specimen, the more chance that fluorescent
microspheres-conjugated anti-Progest/erone antibodies can be captured by the
Progesterone antigen coated on the membrane (Test line). The concentration of
Progest/erone in the specimen is inversely related to the intensity of the fluorescent signal
captured on the T line. According to the fluorescence intensity of the test and the standard
curve, the concentration of Proges/terone in the specimen can be calculated by
Novatrend Plus Analyzer to show Progeste/rone concentration in specimen.
【REAGENTS】
The test include anti-Progeste/rone antibody coated fluorophore and proge/sterone antigen
coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing such
as laboratory coats, disposable gloves and eye protection when specimens are
assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The Progester/one(P4) Test Cassette should only be used with the Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The test should be stored at 4-30°C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the test from contamination.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
1. Collect the specimens according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Serum and
Plasma specimens may be stored at 2-8°C for up to 3 days, for long term storage,
specimens should be kept below -20 °C.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and
thawing of specimens. Only clear, non-hemolyzed specimens can be used.
4. EDTA can be used as the anticoagulant tube for collecting the blood specimen.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge • Fluorescence Immunoassay Analyzer
• Pipette
• Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature
(15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the requirements, select “Standard
test” or “Quick test” mode.
2. Take out the ID card and insert it into the Analyzer port.
3. Pipette 75 μl serum or plasma into the specimen collection tubes with buffer, mix
specimen and buffer well.
Note: The diluted specimen can then be used immediately or stored for up to 4
hours at 2-8℃.
4. Pipette 75 μl diluted specimen into the sample well of the cassette. Start the timer at
the same time.
5. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Novatrend Plus Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: Insert the test cassette into the Analyzer at 15 minutes after
sample application, click “QUICK TEST”, fill the test information and click "NEW
TEST" immediately. The Analyzer will automatically give the test result after a few
seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
sample application, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time, the Analyzer will automatically counting down 15 minutes.
After the countdown, the Analyzer will give the result at once.
