Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO 13485, CE
Model Number:
CRP
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【Product name】
Diagnostic Kit for C-reactive Protein (Immunochromatographic assay)
【Package specification】
25 Tests/kit
【Performance】
1. Detection limit: No higer than 0.5mg/L.
2. Accuracy: the relative deviation from the target value is not more than±10%.
3. Repeatability: coefficient of variation (CV) should be no more than 10%.
4. Inter batch difference: the relative range (R) between batches should be no more than 15%.
5. Linear range: within the specified linear range of 0.5mg/l-200mg/l, the linear correlation coefficient R ≥ 0.990.The absolute deviation of the linear range in [0.5-5] mg/L is not more than ±5 mg/L, the linear range is (5-200] mg/L, the relative deviation is less than±10%.
【Main components】
name | Loading capacity | component |
Test card | 25 | It is composed of fluorescent pad (coated with fluorescent labeled CRP monoclonal antibody), nitrocellulose membrane (coated with CRP monoclonal antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
Sample diluent | 25 | Phosphate buffer |
ID card | 1 | Record the standard curve information of this batch of reagents |
The components in different batches of kits cannot be used interchangeably.
【Storage conditions and validity period】
4℃ - 30℃, dry, dark, no freezing, sealed in aluminum foil bag, valid for 18 months. The test card should be returned to room temperature (15-30)℃ before use, and should be used within 15 minutes after unsealing under the environment of temperature (15-30) ℃ and relative humidity (20% - 90%).
The production date, batch number and expiration date are shown in the outer package of the product.
【Test procedure】
1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the ID card. The test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)
3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
4. Place the test card on a clean horizontal table and mark it horizontally.
5. Add 5μL sample to sample diluent (1500μL), mix well and add 100μL diluted sample to the sampling hole.
6. Insert the test card into dry fluoroimmunoassay analyser, press the “timing test” key, automatically time for 3 minutes, automatically judge the test results, and display the quantitative results on the screen. Or insert the test card into the analyzer after 3 minutes, and press the “Instant test” key, and the instrument will automatically interpret the results.
【Note】
1. The kit is only used for in vitro diagnosis.
2. The test card is disposable and cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15-30) ℃ before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The test card should be taken out from the aluminum foil bag and tested within 15 minutes to avoid being placed in the air for a long time and causing damp.
5. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
6. The kit contains products from animals. The qualified information of animal source and health status cannot guarantee the existence of infectious pathogens. Therefore, it is suggested that these products should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
7. Hematocrit too high or too low may affect the results of whole blood test, it is recommended to use other detection methods for verification.
Assay List | Inflammation | |||||
cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended Use |
10 | CRP / hs-CRP | WB/Serum/Plasma | 3min. | 0.5-200mg/L | CRP<10mg/L,hs-CRP<1mg/L | nonspecficity inflammatory marker. |
11 | SAA | Serum | 5min. | 1-200mg/L | <10mg/L | inflammation&infection. |
12 | PCT | WB/Serum/Plasma | 10min. | 0.2-100ng/ml | <0.5ng/ml | Sepsis |
13 | CRP+SAA | WB/Serum/Plasma | 5min. | same with single item | same with single item | inflammation&infection. |
14 | IL-6 | WB/Serum/Plasma | 10min. | 5-4000pg/ml | 10pg/ml | diabetes,rheumatoid arthritis,etc |
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.
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.
FAQ
Q: What's the minimum order quantity (MOQ)?
A: For most of our medical products, even order for only one unit is warmly welcomed.
Q: Can you do OEM/ private label?
A: Of course we can do OEM/private label for you.
Q: How about your delivery time?
A: 2~10 day depends your order quantity.
Q: What is your terms of delivery?
A: DHL, UPS, FedEx, TNT, EMS, customer's freight forwarder is also available.
Q: What is your terms of payment?
A: China Trade Assurance, T/T in advance, L/C, Western union, paypal
Please suggest your preferred payment method.
Q: Do you have certification?
A: ISO13485, CE
Q: Do you test all your goods before delivery?
A: Yes, we have 100% test before delivery
Q: How about after-sale serive ?
A: We will send you any parts within 15 months warranty, and supply you technology support for long time, solve problem as soon as possible .
Send your inquiry directly to us