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PCT Test Cassette
REF FI-PCT-402
English
Local inflammation or infection is possible but a low risk for
progression to systemic inflammation response
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Hangzhou AllTest Biotech Co., Ltd.
MedNet EC-REP GmbH
Borkstrasse 10
48163 Muenster
Germany
(Whole Blood/Serum/Plasma)
Package Insert
A test for the diagnosis of inflammatory condition by measuring Procalcitonin (PCT) in whole
blood, serum or plasma with the use of Fluorescence Immunoassay Analyzer.
【
INTENDED USE】
The PCT Test Cassette (Whole Blood/Serum/Plasma) is based on Fluorescence
immunoassay for the quantitative detection of human Procalcitonin in 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 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】
Blood Sample Taking
1. Collect the specimen according to standard procedures.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab.
Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand
towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over
the puncture site.
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 75 μL of serum/plasma/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】
•Test Cassettes • Specimen collection tubes with buffer
•ID Card • Package Insert
• Droppers • Lancets
•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 analyzer. 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 need, select “Standard test” or “Quick
test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. To use a pipette: Pipette 75μL of sample into the buffer tube; mix the specimen and the
buffer well.
To use a dropper: Immerse the tube end into the sample; squeeze the top bulb to absorb
the sample into the lower bulb (no more than the lower bulb). Then release the sample into
the buffer tube by squeezing the bulb at the top end of the dropper vertically. Wash the
tube 2-3 times by squeezing the top bulb. Mix the sample and the buffer well.
4. To use a pipette: Pipette 75 μL of diluted specimen into the sample well of the cassette.
Start the timer at the same time.
To use a dropper: Immerse the tube end into the diluted sample; squeeze the top bulb to
absorb the solution into the lower bulb (no more than the lower bulb). Squeeze the top bulb
vertically to release the diluted solution into the sample well of the test cassette and start
the timer.
5. There are two test modes for Fluorescence Immunoassay Analyzer, Standard Test mode
and Quick Test mode. Please refer to the user manual of Fluorescence Immunoassay
Analyzer for details.
“Quick test” mode：After 15 minutes of adding sample，Insert the test cassette into the
Analyzer and click “QUICK TEST”, fill the test information and click "NEW T EST" 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 adding
specimen, click “ STANDARD T EST”, fill the test information and click "NEW TEST" at the
same time. The Analyzer will automatically countdown 15 minutes. After the countdown, the
Analyzer will give the result at once.
【
INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay 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 Analyze.
Linearity range of PCT is 0.1-50 ng/mL.
Reference range: ＜0.1ng/mL.
【QUALITY CONTROL】
Each PCT Test Cassette contains internal control that satisfies routine quality control
requirements. This internal control is performed each time a sample is tested. This control
indicates that the test cassette was inserted and read properly by Fluorescence Immunoassay
Analyzer. An invalid result from the internal control causes an error message on
Immunoassay Analyzer indicating that the test should be repeated.
LIMITATIONS】
【
1. The PCT Test Cassette (Whole Blood/Serum/Plasma) is for professional in vit ro diagnostic
use, and should only be used for the quantitative detection of procalcitonin.
2. The PCT Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of
PCT antigen in the specimen and should not be used as the sole criteria for evaluating
inflammatory conditions.
3. Like with all diagnostic tests, a confirmed diagnosis should only be made by a physician
after all clinical and laboratory findings have been evaluated.
Materials Provided
Materials Required But Not Provided
Fluorescence
4. High concentrations of PCT may lead to hook effects, resulting in incorrect interpretation of
PCT levels.
5. The results of PCT Tests are based on measuring the levels of Procalcitonin in a specimen.
It should not be used as the sole criterion for treatment decisions. If the result is positive,
other clinical findings and alternative test methods are recommended to reach proper
medical treatments.
【
EXPECTED RESULTS】
Concentrations Expected Clinical Conditions
＜0.1 ng/mL Normal Condition
0.1-0.5 ng/mL
0.5-2.0 ng/mL High possibility of Systemic inflammatory response
2.0-10 ng/mL Systemic inflammatory response associated with infection
>10 ng/mL Progressing on severe sepsis or septic shock
【PERFORMANCE CHARACTERISTICS】
1. Accuracy
The test deviation is≤±15%.
2. Assay Range and Detection Limit
Assay Range: 0.1 – 50 ng/mL
Minimum Detection Limit (Analytical Sensitivity): 0.1 ng/mL
3. Linearity range
0.1~50 ng/mL , R≥0.990
4. Precision
CV≤15%
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2 specimens containing 0.5
ng/mL, 2.0 ng/mL of PCT. C.V. is ≤15%.
Inter-lot precision
Between-run precision has been determined by using 10 replicates for each of three lots using
2 specimens containing 0.5 ng/mL, 2.0 ng/mL of PCT. C.V. is ≤15%.
5. Method comparison
The assay was compared with PCT Test of ET healthcare Co.,Ltd with 110 samples. The
correlation coefficient(r) is 0.981.
BIBLIOGRAPHY】
【
1. Le Moullec JM, et al. (1984) The complete sequence of human procalcitonin. FEBS Letters
167(1), 93-97.
2. Assicot M, et al. (1993) High serum procalcitonin concentrations in patients with sepsis and
infection. Lancet 341(8844), 515-518.
3. Meisner M and Reinhart K (2001) Is procalcitonin really a marker of sepsis? Int J Intensive
Care 8(1), 15-25.
4. Sponholz C, et al. (2006) Diagnostic value and prognostic implications of serum
procalcitonin after cardiac surgery: a systematic review of the literature. Critical Care 10,
R145.
5. Meisner M, (2002) Pathobiochemistry and clinical use of procalcitonin. Clin Chim Acta 323,
17-29.
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Number: F145107500
Revision date: 2022-09-23
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