What is the Scientific Data from Instrument and Reagent Supplier?
Technology Method:
Polymerase Chain Reaction (PCR)
Limit of Detection:
1 x 104 CFU/mL (Colony Forming Units)
Sensitivity:
In the kit’s positive and negative reference controls, the positive and negative coincidence rates were 100%.
Specificity:
No cross-reactivity of the kit between the microorganisms was observed.
Accuracy:
Precision reference controls were checked 10 times, and the Ct value’s coefficient of variation (CV%) was no greater than 5%.
Result/Outcome/Range –
Positive/Negative/Inconclusive
Validation-Active Information:
- EQA: Yes
- Inter-laboratory validations
- Periodic according to the validation schedule
- Event-triggered- QC/Calibration/New materials/Batch
Accuracy
The accuracy of our Ureaplasma Diagnostic PCR method is defined as the combination of sensitivity and specificity variables. Sensitivity confirms positive results, and specificity eliminates negative results. Furthermore, all our exams are validated with high accuracy (up to 98.5%).
Variables
Accuracy can be affected by various factors that our lab cannot control. For example, virus intensity, patient health, and sample quality depend on adherence to “home sampling” procedures. All of these can limit the results. Although our exams are extremely sensitive, a poor-quality swab makes detecting its presence harder. Also, fewer viral particles will be present. So, please carefully consider the information sheet accompanying your sample collection kit to ensure a high-quality sample.
Detection
It can accurately check for the presence of the Ureaplasma urealyticum. It uses a Polymerase Chain Reaction (PCR) amplifying method to detect the pathogen.
Positive result
A positive result suggests the presence of particles in the sample during sampling; upon receiving positive results, you should contact your GP for a cure. It is possible that the Ureaplasma urealyticum does not present symptoms, but you may still transmit it to others.
Negative result
While this can provide reassurance, it is important to understand its significance. This means the exam did not detect the presence at the time of sampling. Moreover, the results should still be discussed with a GP while considering lifestyle and history. But if you are in contact with someone who is positive or begins to present symptoms, you should contact your GP.
Self Swab/Tub
Ureaplasma PCR
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