The PCT Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence
immunoassay for the quantitative detection of Procalcitonin in human whole blood, serum or
plasma as an aid in the diagnosis of inflammatory conditions.
【SUMMARY】
Procalcitonin (PCT) is a small protein that comprises 116 amino acid residues with a molecular
weight of approximately 13 kDa which was first described by Moullec et al. in 1984. PCT is
produced normally in C-cells of the thyroid glands. In 1993, the elevated level of PCT in
patients with systemic infection of bacterial origin was reported and PCT is now considered to
be the main marker of disorders accompanied by systemic inflammation and sepsis. The
diagnostic value of PCT is important due to the close correlation between PCT concentration
and the severity of inflammation. It was shown that “inflammatory” PCT is not produced in
C-cells. Cells of neuroendocrine origin are presumably the source of PCT during inflammation.
【PRINCIPLE】
The PCT Test Cassette (Whole Blood/Serum/Plasma) detects PCT based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad. If the
specimen contains Procalcitonin, it attaches to the fluorescent microspheres-conjugated
anti-procalcitonin antibodies. Then the complex will be captured by the capture antibodies
coated on the nitrocellulose membrane (Test line). The concentration of PCT in the sample
correlates with the fluorescence signal intensity captured on the T line. According to the
fluorescence intensity of the test and the standard curve, the concentration of PCT in the
sample can be calculated by
Analyzer to show PCT concentration in specimen.
【REAGENTS】
The test includes anti-Procalcitonin antibody coated fluorphores and anti-Procalcitonin
antibody 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 PCT Test Cassette should only be used with the analyzer by 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】
Blood Sample Taking
1. Collect the specimen 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. Whole blood collected by venipuncture should be
stored at 2-8 °C if the test is to be used within 2 days of collection. Do not freeze whole
blood specimens. Whole blood collected by finger stick should be tested immediately.
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.
4. EDTA, Heparin sodium can be used as the anticoagulant tube for collecting the blood
specimen.
Sample Dilution / Sample Stability
1. Transfer 50μL of serum or plasma / 75 μL of whole blood to the buffer tube with the micro
pipette.
2. Close the tube and shake the sample by hand vigorously for approximately 10seconds to
mix the sample and dilution buffer.
3. Let the diluted sample homogenize for approximately 1 minute. The sample can then be
used immediately or stored for up to 8 hours.
【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 User Operation Manual for the complete
instructions for the use of the analyzer. The test should be conducted at room temperature.
Allow the test, specimen and buffer to reach room temperature (15-30 °C) prior to
testing.
1. Turn on the Analyzer power.
2. Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or sample
type according to needs.
3. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best
results will be obtained if the assay is performed immediately after opening the foil pouch.
4. Place the test on a flat and clean surface.
Serum or plasma: Pipette 50μL of serum or plasma into the buffer tube; mix the
specimen and the buffer well.
Whole blood: Pipette 75μL of whole blood into the buffer tube; mix the specimen and the
buffer well.
5. Pipette 75 μL of diluted sample into the sample well of the cassette. Start the timer at the
same time.
6. Test results should be interpreted at 15 minutes with the use of Fluorescence
Immunoassay Analyzer.
Caution: There are different test modes of the Fluorescence Immunoassay Analyzer. The
difference between them is incubation of the test cassette is outside or inside the analyzer.
Choose test mode accordingly and confirm sample type. Consult the user manual of the
analyzer for detailed operation information.
Operator must consult the Fluorescence Immunoassay Analyzer User Manual prior to use and
become familiar with the processes and quality control procedures.
【INTERPRETATION OF RESULTS】
Results read by Fluorescence Analyzer.
The result of tests for PCT is calculated by Fluorescence Immunoassay Analyzer and display
the result on the screen. For additional information, please refer to the user manual of
Fluorescence Immunoassay Analyzer.
Linearity range of PCT is 0.1-50 ng/mL.
Reference range: ＜0.1ng/mL.
