Diagnostic kit for IgM Antibody to Mycoplasma Pnemoniae Colloidal Gold
Diagnostic kit for IgM Antibody to Mycoplasma Pnemoniae Colloidal Gold
Production information
| Model Number | MP-IgM | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic kit for IgM Antibody to Mycoplasma Pnemoniae Colloidal Gold | Instrument classification | Class I |
| Features | High sensitivity, Easy opeation | Certificate | CE/ ISO13485 |
| Accuracy | > 99% | Shelf life | Two Years |
| Methodology | Colloidal Gold | OEM/ODM service | Avaliable |
Test procedure
| 1 | Take the test device out of aluminum foil bag, place it on a flat tabletop and properlymark the sample. |
| 2 | Add 10uL of serum or plasma sample or 20uL of whole blood to sample hole, and thendrip 100uL (about 2-3 drops) of sample diluent to sample hole and start timing. |
| 3 | Result should be read within 10-15 minutes. Test result will be invalid after 15 minutes. |
Note: each sample shall be pipetted by clean disposable pipette to avoid cross contamination.
Intend Use
This kit is intended for in vitro qualitative detect the content of IgM antibody to Mycoplasma Pneumoniae in human serum/plasma/whole blood sample and is used for auxiliary diagnosis for Mycoplasma Pneumoniae infection. This kit only provides the test result of IgM antibody to Mycoplasma Pneumoniae, and the obtained result shall be analyzed in combination with other clinical information. This kit is for healthcare professionals.
Summary
Mycoplasma Pneumoniae is very common. It is spread by oral and nasal secretions through air, induce sporadic or small-scale epidemic. Mycoplasma Pneumoniae infection has an incubation period of 14~21 days, mostly progresses slowly, with about 1/3~1/2 being asymptomatic and can only be detected by X-ray fluoroscopy. The infection is usually manifested as pharyngitis, tracheobronchitis, pneumonia, myringitis etc., with pneumonia as the severest. Serological test method of Mycoplasma Pneumoniae in combination with immunofluorescence test (IF), ELISA, indirect blood agglutination test and passive agglutination test has diagnostic significance for early IgM antibody increase or recovery-phase IgG antibody.
Feature:
• High sensitive
• result reading in 15 minutes
• Easy operation
• Factory direct price
• Do not need extra machine for result reading
Result reading
The WIZ BIOTECH reagent test will be compared with the control reagent:
| Test result of wiz | Test result of reference reagents | Positive coincidence rate:99.16%(95%C.I.95.39%~99.85%) Negative coincidence rate:
100%(95%C.I.98.03%~99.77%) Total compliance rate: 99.628%(95%C.I.98.2%~99.942%) |
||
| Positive | Negative | Total | ||
| Positive | 118 | 0 | 118 | |
| Negative | 1 | 191 | 192 | |
| Total | 119 | 191 | 310 | |
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