What is the Scientific Data from the Mycoplasma Instrument and Reagent Supplier?
Technology Method:
Polymerase Chain Reaction (PCR)
Limit of Detection:
268 copies/ml.
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 any of our diagnostic exam is defined as the combination of sensitivity and specificity variables. Sensitivity is the methods ability to confirm positive results; specificity eliminates negative results. 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. Infection intensity, patient health, and sample quality, dependent on adherence to “home sampling” procedures, can all limit the results. Although our methods are extremely sensitive, a poor-quality swab makes it harder to detect the presence of infection, as fewer viral particles will be present. Please carefully consider the information sheet accompanying your sample collection kit to ensure a high-quality sample.
Detection
The Mycoplasma Kit can detect the presence of the Myco genitalium bacteria to a high degree of accuracy. The exam uses a Polymerase Chain Reaction (PCR) amplifying method to detect the pathogen.
Positive result
A positive MGen Test result suggests the presence of viral particles in the sample during testing. Upon receiving positive results, we advise you to contact your healthcare provider for treatment. You can also gain a prescription through our website. It is possible the bacteria do not present symptoms of the disease, but you may still be infectious to others.
Negative result
While this can provide reassurance, it is important to understand its significance. However, this means the exam did not detect the presence of infection at the time of sampling. Results should still be discussed with a healthcare provider while considering lifestyle and sexual history. However, if you are in contact with someone who is positive for the disease or begins to present symptoms consistent with the disease, you should contact your GP.
Swab Stick
Mycoplasma Genitalium PCR
K –
been using them for years. Very good customer service compared to others.
Katrina Suzzane –
I had a satisfactory service and found their prices to be a bit low on the side in comparison to the other labs prices I checked for the same test.
Ayleen Russo –
This is a self swab test and does not need finger pricking which was a big relief as I had always been very afraid of needles. Nevertheless, I had a very smooth experience throughout.
Fiona K. –
They was very easy to use. I appreciated the clear instructions provided.
Kelly –
Got my results next day. all good. I can recommend this service