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The Myo Rapid Test Kit is is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of Myo. The Myo antigen in the sample was first bound with the conjugated compound of fluorescent labeled Myo monoclonal antibody, then moved and combined with another Myo monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test cards||25||It is composed of fluorescent pad (coated with fluorescently-labeled Myo monoclonal mouse antibody), nitrocellulose membrane (coated with Myo monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing|
|Sample diluent||25||Phosphate buffer|
|ID card||1||With specific stand curve file|
The components in different batches of Myo Rapid Quantitative Test Kits cannot be used interchangeably.
【Storage conditions and validity】
Myo Rapid Quantitative Test 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.
Mod:NIR-1000 Dry Fluoroimmunoassay Analyser produced by WWHS Biotech.Inc.
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 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. Mix 10 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 12 minutes after addition of samples, then dispose of used test appropriately.
The normal reference value is less than 58ng/mL in this assay. It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Limitation of rest method】
1. Myo Rapid Quantitative Test Kit is only used to detect human plasma/ serum and whole blood samples
2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.
3. The content of triglyceride in the sample shall not exceed 10mg/mL, the content of hemoglobin shall not exceed 10mg/mL, and the content of bilirubin shall not exceed 0.5mg/mL, and the relative deviation of the test results shall not exceed ±15%.
4. When the concentration of Myo in the sample is less than 4000.00ng/mL, there is no hook effect.
5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.
6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±10.0%.
【Myo Rapid Quantitative Test Kit performance indicators】
Limi higher than 5.00 ng/mL.
The relative deviation from the target value is limited to ±15.0%.
The within and between assay coefficient of variations are within 15%.
3. Linearity range
Within the linear range (5.00~ 400.00ng/mL), the linear correlation coefficient R≥0.990.
1. Myo Rapid Quantitative Test 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 Myo Rapid Quantitative Test 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.
6. Myo Rapid Quantitative Test 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.
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