Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO13485, CE
Model Number:
HbA1c
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【Product Name】
Haemoglobin A1c(HbA1c)Rapid Quantitative Test (Fluorescence immunoassay)
【Packing Specification】
25 Tests/kit
【Intended Use】
The kit is used for quantitative determination of HbA1c in human whole blood,and is mainly used for diagnosis of diabetes and monitoring of blood glucose level clinically.
【Performance 】
1. Limits of detection,No higher than 4.0%.
2. Accuracy,The relative deviation to the target value is limited to ±10.0%.
3. Repeatability,Coefficient of variations are within 10%.
4. Batch-to-batch difference,The relative range (R) between batches shall not be greater than 15.0%.
5. Linearity range,Within the specified linearity range (4.0%-14.0%):
a) Linearly dependent coefficient (r) is no less than 0.9900;
b) Within (4.0%-6.0%), linear absolute deviation is limited to ±0.6%.
Within (6.0%-14.0%), linear absolute deviation is limited to ±10.0%.
【Components】
| Name | Quantity | Component |
| Test cards | 25 | The product consists of fluorescent mat (coated with fluorescently-labeled HbA1c mouse antibody), nitrocellulose membrane (coated with HbA1c mouse antibody and Goat anti mouse IgG antibody), absorbent paper and PVC soleplate, and so on. |
| Sample diluent | 25 (1.0mL/ tube) | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used interchangeably.
【Storage Conditions and Validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
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 fluorescence immunoassay analyzer 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 information card. The information card is inserted before use, so it is not necessary to calibrate again, and 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 10μL of sample into HbA1c sample diluent (1.00mL). After mixing thoroughly the solution for 1 min, take 100μL of the solution and add it into the well.
6,Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 10 minutes after addition of samples, then dispose of used test appropriately.
【Note】
1. The kit can be used for in vitro diagnosis only.
2. Test card and buffer solution are single-use and they 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. 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.
5. 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.
The kit used 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
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
Why Choose WWHS
Our company's main business is INFRARED fluorescent POCT. The main application scenarios of POCT include emergency department, ICU, chest pain center and stroke center, operating room, and various departments of grade hospitals. Community health, outpatient and other primary medical institutions at all levels; Pharmacies, home use and other organizations and individuals targeted at end customers. POCT is characterized by its simplicity and speed, freedom from application scenarios, and high cost performance. However, the current pain point of POCT industry lies in how to solve the problems of low sensitivity and poor precision faced by POCT products.
Smarter Operation
1. High Quality: Imported Major Components with Advanced German Technology
2.User-Friendly Design: 7 Inch touch screen, great touch feeling, simple graphic interface
3. Built-In Lithium Battery: High Mobility for first aid&amulance
4. Two Test Mode: Internal&External mode for different clinical needs
5. Smart Report: Auto Printing
6. Visual Results: Able to connect with LIH/HIS
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