3. Please check the integrity and expiration date of the kit package before use, then open the package, and when stored at low temperature, it should be restored to 20~30ºC before opening the package for use. Direct use at low temperature will affect the test results.4. Whether the patient has inflammatory bacterial infection should be judged by the sician in combination with clinical features and symptoms, as well as other diagnostic methods of the patient.Â
Limit of the Test MethodÂ
1. The test results can only be used as an aid to sicians or other diagnoses, and need to be combined with other clinical and laboratory data; if the test results do not match the clinical assessment, further examination is required.Â
2. Bilirubin ≤0.5mg/mL, triglycerides ≤10mg/mL, hemoglobin ≤5mg/mL, within ±10% deviation to the test results.Â
3. The HOOK effect will not occur when the HbA1c concentration content in the sample is ≤20%.Â
4. If the sample test result shows more than 14%, it is recommended to dilute the sample with sa maximum dilution should not exceed 1:5), and the concentration value of the test obtained after its dilution, then multiply the dilution times to calculate the sample concentration value.Â
Performance CharacteristicsÂ
1. ngeÂ
In the range of 4%-14%, the r value should be ≥ 0.990.Â
2. AccuracyÂ
Detected with the enterprise internal control accuracy reference (C1, C2), the test results should be within the following ranges.Â
(1) Detection with the enterprise internal control accuracy reference C1, the instrument measurement range is 6.4% ±15% at 15 minutes.Â
(2) Detection with the enterprise internal control accuracy reference C2, the instrument measurement range is 8.4% ±15% at 15 minutes..Â
3. Intra-batch precisionÂ
Using the enterprise internal control precision reference (C9, C10) each parallel test 10 times, at 15 minutes instrumentation, the concentration value coefficient of variation CV≤15%.Â
4.Inter-batch precisionÂ
For three batches of reagent kits, 10 times of parallel testing with each enterprise internal control precision reference (C9, C10), and the instrument measurement at 15 minutes, the concentration coefficient of variation CV≤15%.Â
5.Detection limitÂ
Detection with the enterprise internal control of the detection limit reference L1, instrumentation at 15 minutes, the results should be ≤4%.Â
6.SpecificityÂ
Detection with the enterprise internal control specificity reference (C3, C4, C5), the instrument measurement value at 15 minutes should be less than 6%.
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NotesÂ
1. This kit is only for in vitro diagnosis, one-time use, please do not reuse.Â
2. Kits should be treated as containing infectious material.Â
3. Please check the integrity of the kit packaging and expiration date before use.Â
4. Please read the instructions for use of this reagent and instrument in detail before all operations.Â
5. Please operate in strict accordance with the requirements of the instructions. After the test starts, it cannot be stopped halfway. If it is stopped halfway, the test cannot be resumed. If you need to retest, you must update the reagents and retest.Â
6. Each batch of reagents has corresponding parameters in the supporting instrument, and the manufacturer updates the parameters in the instrument regularly. If the new batch of reagents is not recognized by the instrument, please the manufacturer to update the parameters in time.Â
7. The test card should not be used for more than 1Â hour after opening.Â
8. Reagents with different batch cannot be mixed, and ID cards and test cards cannot be used with different batch .Â
9. Excessive experimental temperature should be avoided, and the test card stored at low temperature needs to be restored to room temperature before opening to avoid moisture absorption.
