Diagnostic Kit for procalcitonin(Immunochromatographic assay)

Ⅰ.Applicable Instrument

Mod:NIR-1000 Dry Fluoroimmunoassay Analyser produced by WWHS Biotech.Inc.

Ⅱ.product description

1. Intended Use:Diagnostic Kit for procalcitonin is used to determine the content of procalcitonin (PCT) in whole blood, plasma and serum of human body and is mainly used clinically for auxiliary diagnosis of bacterial infectious diseases.

2. Main Ingredients

Ingredients of kits of different batch numbers cannot be exchanged.

Ⅲ.Experimental operation Procedure

1. 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.

2. 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.)

3. Take out the test card from the aluminum foil bag and use it within 15min.

4. Place the test card on a clean horizontal table top and label it.

5. Serum, plasma or whole blood specimen: 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.

6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser and press 【Fixed time 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 test result automatically.

Ⅳ.Why to choose us?

1. Detection limit

Test 5 low-value samples whose concentration is approximate to LOD (0.2ng/mL) 5 times respectively and sort the test results. There should be no more than 3 test results lower than the blank value (0.12ng/mL).

2. Accuracy

The relative deviation to the target value is limited to ±15%.

3. Precision

Within-run precision CV≤15%; between-run relative limit R≤15%.

4. Linearity range

Within the specified linearity range (0.2-100) ng/mL, linearly dependent coefficient r≥0.990.

Ⅴ.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 18 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.

Ⅵ.