PCT Rapid Test Kit IFA Colloidal Gold IVD Diagnostic WWHS FIA POCT

[Product Name]

Procalcitonin (PCT) Rapid Quantitative Test (Fluorescence immunoassay)

[Packing Specification]

25 Tests/kit

[Intended Use]

The product 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.

[Test Principle]

The kit uses immunochromatographic assay. First, PCT antigen in the sample combines with the fluorescently-labeled PCT monoclonal antibody conjugate. Then, it continues to move and combines with another PCT monoclonal antibody fixed on the nitrocellulose membrane to form double-antibody sandwich immune complex in the position of the nitrocellulose membrane test line and analyze and obtain quantitative test result using NIR-1000 dry fluoroimmunoassay analyser.

[Main Ingredients]

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.

[Applicable Instrument]

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

[Sample Requirements]

1. Serum and EDTA·Na₂ anticoagulant plasma and whole blood, EDTA·K₂ anticoagulant plasma and whole blood, sodium citrate anticoagulant plasma and whole blood can be used.
2. Collect venous blood using coventional laboratory method. Clinical samples should be tested at room temperature (15℃-30℃) in 4h after collected. Whole blood specimens can be stored at (2-8)℃ for 24h; serum or plasma specimens can be stored at (2-8)℃ for 7 days and at -20ºC for 30 days.
3. The sample must be rewarmed to room temperature (15-30)℃ before test. Frozen samples should be completely melted, rewarmed and mixed before use and should not be frozen repeatedly.
4. Please do not test samples of severe hemolysis, severe lipoidemia and icterus.

[Test Method]

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. 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 “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.

【Reference Interval】

Determine 254 healthy people aged 18-68 and carry out statistical analysis. Result shows that the upper limit of the reference value is 0.5ng/mL at the 95^th percentile, so the reference interval is less than 0.5ng/mL.

The laboratory should establish a reference range according to characteristics of local people.

[Interpretation of Test Results]

1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.

2. For samples whose PCT concentration is lower than 0.2ng/mL and higher than 100ng/mL, test result is “＜0.2ng/mL” and “＞100ng/mL” respectively.

[Limitation of Test Method]

1. The kit can be used to test whole blood, plasma and serum specimens of human body only.

2. Due to limitations of serological methods for antigen and antibody response, the test result cannot be used as the only basis for clinical diagnosis and should be evaluated together with all existing clinical and experimental data.

3. The content of triglyceride contained in the sample is no more than 10mg/mL, that of hemoglobin is no more than 6mg/mL and that of hemoglobin is no more than 0.6mg/mL, and the relative deviation is limited to ±15%.
4. When PCT concentration of samples is less than 250ng/mL, Hook effect is not observed.

5. When human anti mouse concentration of samples is less than 50ng/mL, HAMA effect will not be observed.

6. When RF concentration of samples is less than 2000 IU/mL, the test result will not be affected.

[Product Performance Indicators]

1. Limit of detection

No more than 0.2ng/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.

【Precautions】

1. Test card is single-use and it cannot be reused.
2. Please inspect packaging integrity and validity of kit before use and then unpack the product. If the product is stored at low temperature, restore to room temperature (15℃-30℃) before unpacking and use. Reagent cannot be used if packaging is damaged and the validity period expires.
3. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
4. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
5. The kit contains products from animals. Eligible information about animal source and sanitary condition cannot absolutely ensure inexistence of infectious pathogen. Therefore, these products should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
6. Too high or too low hematocrit of red cells may affect whole blood test result, so verification should be conducted using other methods .

Note:

1) Any variation in operator, pipetting and washing technique, incubation time or temperature, and kit age can cause variation in
result. Each user should obtain their own standard curve.
2) If samples have been diluted, the concentration read from the standard curve must be multiplied by the dilution factor.
3) If specimens generate values higher than the highest standard, dilute the specimens and repeat the assay

Our Service

Pre-sale services:

1.Supply our complete catalogue for your reference.

2.Help you to learn more details of our equipment.

3.Design and produce the equipment as per your requirement

4.provide diagnostic solution for you

Sales Service:

1. Professional service of the whole exporting processing .

2. Give supporting on your sales chennel establishment of our products.

3. OEM accepted.

After Services:

1.Guarantee for 1 year

2.Quik answer and solution for any problem during your operation

Packing and Delivery

Packing: Standard packing, neutral packing, OEM packaging are welcome;
Delivery: According to the specific quantity of the product;
Payment: Credit Card, Paypal, Local Bank, Western Union, T/T, etc.

Shipping: International Express, by Air, by Sea, etc;

1. International Express
For MOQ (2ctns to 5ctns),we will recommend you ship the goods by international express(DHL, FedEx, EMS, TNT etc, are all available.) The goods will be shipped within 10~15 days after received the full payment.
2. Air Transportation
Between 5ctns to 10ctns, we will recommend you ship the goods by air. The goods will be shipped within 15~30 days after received the full payment.
3. Sea Transportation
More than 10 ctns we will recommend you ship the goods by sea. The goods will be shipped within 30~45 days after received the full payment.