Diagnostic kit for IgM Antibody to C Pneumoniae Colloidal Gold
Diagnostic kit for IgM Antibody to C Pneumoniae
Colloidal Gold
Production information
| Model Number | MP-IgM | Packing | 25 Tests/ kit, 30kits/CTN |
| Name | Diagnostic kit for IgM Antibody to C Pneumoniae 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 then
drip 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 applicable to in vitro qualitative detection of antibody to chlamydia pneumoniae in human serum/plasma/whole blood sample, and it’s used for auxiliary diagnosis of chlamydia pneumoniae infection. This kit only provides test results of IgM antibody to chlamydia pneumoniae, and results obtained shall be used in combination with other clinical information for analysis. This kit is for healthcare professionals.
Summary
Genus chlamydia includes four species, i.e. chlamydia trachomatis, chlamydia psittaci, chlamydia pneumoniae andchlamydia pecorum. Chlamydia trachomatis can cause trachoma and genitourinary system infection,chlamydia pneumoniae and chlamydia psittaci can cause various respiratory infections, while chlamydia pecorum will not cause human infeciton. Chlamydia pneumoniae is more commonly seen in human respiratory infections than chlamydia psittaci, but people didn’t realize it is an important pathogen of respiratory tract infection until late 1980s. According to seroepidemiological survey, chlamydia pneumoniae infection of human beings is worldwide and positively correlated with population density.
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:99.39%(95%C.I.96.61%~99.89%) Negative coincidence rate:100%(95%C.I.97.63%~100%)
Total compliance rate: 99.69%(95%C.I.98.26%~99.94%) |
||
| Positive | Negative | Total | ||
| Positive | 162 | 0 | 162 | |
| Negative | 1 | 158 | 159 | |
| Total | 163 | 158 | 321 | |
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