The Cys-C Test Cassette (whole blood/Serum/Plasma) is based on Fluorescence
Immunoassay to measure Cys-C in whole blood or serum or plasma to aid in the
diagnosis of Renal function.
【SUMMARY】
Cystatin C or cystatin 3 (formerly gamma trace, post-gamma-globulin, or neuroendocrine
basic polypeptide),[1] a protein encoded by the CST3 gene, is mainly used as a biomarker
of kidney function.
Cystatin C has a low molecular weight (approximately 13.3 kilodaltons), and it is removed
from the bloodstream by glomerular filtration in the kidneys. If kidney function and
glomerular filtration rate decline, the blood levels of cystatin C rise. Cross-sectional
studies (based on a single point in time) suggest that serum levels of cystatin C are a
more precise test of kidney function (as represented by the glomerular filtration rate, GFR)
than serum creatinine levels.[2][3] Longitudinal studies (following cystatin C over time) are
sparse, but some show promising results.[4][5][6] Cystatin C levels are less dependent on
age, gender, ethnicity and muscle mass compared to creatinine.
【PRINCIPLE】
The FIATESTTM Cys-C Test Cassette detects Cys-C based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad. If
the test sample contains Cys-C, it attaches to the Cys-C antibody which is conjugated
with fluorescent microspheres. Then the complex will be captured by the capture antibody
coated on the nitrocellulose membrane(Test line).The concentration of Cys-C in the
sample correlates linearly with the fluorescence signal intensity captured on the T line.
According to the fluorescence intensity of the test and product standard curve, the
concentration of Cys-C in the sample can be calculated by Novatrend Plus Analyzer to show
Cys-C concentration in specimen.
【REAGENTS】
The test cassette contains anti-Cys-C antibody coated particles and anti-Cys-C 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. This test contains products of animal origin. Certified knowledge of the origin and/or
sanitary state of the animals does not completely guarantee the absence of transmissible
pathogenic agents. It is therefore recommended that these products be treated as
potentially infectious, and handled observing usual safety precautions (e.g., do not ingest
or inhale).
4. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
5. 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.
6. Do not interchange or mix reagents from different lots.
7. Humidity and temperature can adversely affect results.
8. Used testing materials should be discarded in accordance with local regulations.
9. Read the entire procedure carefully prior to any testing.
10. The Novatrend Plus Cys-C Test Cassette is only operational in the Novatrend Plus Analyzer.
And tests should be applied by professionally trained staff working in certified laboratories
at some remove from the patient and clinic at which the sample(s) is taken by qualified
medical personnel.
【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】
Sample Taking
Collect the specimen according to standard procedures.
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 may be stored at 2-8°C up to 2
days and do not freeze.
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.
EDTA, Heparin sodium, 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 •FIATESTTM Fluorescence Immunoassay Analyzer
• Pipette • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Novatrend Plus Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be in room temperature.
Allow the test cassette, 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. Remove the ID card and insert it into the Analyzer port.
3. Pipette 20μl of specimen into the buffer tube, then mix thoroughly.
4. Pipette 75μl diluted sample into the sample well. 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: After 10 minutes of adding sample,Insert the test cassette into
the Analyzer 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
adding specimen, click "New test" at the same time, The Analyzer will automatically
countdown 10 minutes. After the countdown, the Analyzer will give the result at once.