[Product Name]
Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence
immunoassay)
[Packing Specification]
25 Tests/kit
Product Performance Indicators]
- Limit of detection
No more than 0.2ng/mL
- Accuracy
The relative deviation to the target value is limited to ±15%.
- Precision
Within-run precision CV≤15%; between-run relative limit R≤15%.
- Linearity range
Within the specified linearity range (0.2-100) ng/mL, linearly
dependent coefficient r≥0.990.
[Main Ingredients]
| Name | Loading capacity | Ingredient |
| Test card | 25 | The product consists of fluorescent mat (coated with
fluorescently-labeled PCT monoclonal murine antibody),
nitrocellulose membrane (coated with PCT monoclonal murine antibody
and goat anti mouse IgG antibody), absorbent paper and bottom
lining. |
| Sample diluent | 25 | Phosphate buffer |
| ID card | 1 | Record standard curve information of this batch of reagents |
Ingredients of kits of different batch numbers cannot be exchanged.
[Storage Conditions and Validity]
The product should be stored at 4℃-30℃ in a dry and dark place,
sealed using aluminum foil bag and must not be frozen. The storage
life is 12 months. The test card should be unpacked at room
temprature (15℃-30℃) and should be used in 15min after unpacked at
a temperature of (15-30)℃ and relative humidity of 20%-90%.
See outer packing for production date, batch number and expiry
date.
[Test Method]
- Please thoroughly read the specification before test. Frozen test
card and sample should be placed at room temperature (15-30)℃ for
at least 30min before use.
- Start NIR-1000 dry
fluoroimmunoassay analyser and verify quality control according to
the specification. (Note: Reagent has been calibrated in advance
and calibration curve parameters of each batch of reagents have
been stored in the information card. Insert the information card
before use and carry out test without re-calibration after passing
quality inspection; otherwise, identify the cause before test.)
- Take out the test card from the aluminum foil bag and use it within
15min
- Place the test card on a clean horizontal table top and label it.
- Take 100μL of sample and add it into 300μL of buffer solution
(1:3). Then, mix the solution evenly, take 100μL of the solution
and add it into the test card well.
- Insert the test card into NIR-1000 dry fluoroimmunoassay analyser
and press “Timing test” to keep time for 10min automatically. The
analyzer will judge and read the test result automatically and
display it in the screen. Or insert the test card into the analyzer
after 10min and press “Instant test”, the instrument will judge and
read the result automatically.
Interpretation of results
1. This reagent is only used for auxiliary detection. If the test
results are abnormal, it should be reviewed in time and judged in
combination with clinical symptoms.
2. For samples with AFP concentration lower than 2.5ng/ml and
higher than 200ng/ml, the detection results are reported as "<
2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human plasma/whole blood samples
2. Due to the limitations of immunoassay methods of antigen and
antibody reaction, the results cannot be used as the only basis for
clinical diagnosis, but should be evaluated with all the existing
clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed
15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the
content of bilirubin shall not exceed 0.5mg/ml, and the relative
deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than
20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human
anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the
relative deviation of the test results is within ±15%.
Applicable Instrument
WWHS NIR-1000 dry fluoroimmunoassay analyser
Notice
1) The test card can be used only once at room temperature, do not
reuse or use test card out of expiry date.
2) Return all reagents and sample into room temperature before use.
3) Be careful when prepare sample, wear glove and mask.
4) The whole blood need add anticoagulants, not frozen; serum
sample can store in frozen, avoid repeated freezing and thawing.
5) This product is only for in vitro rapid diagnostic human use,
can be quantified, not only qualitative testing.
6) The product test results for reference only, for confirmation,
please refer to the relevant national standard methods.
