Scientific Information 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 tested 10 times, and the coefficient of variation (CV%), of the Ct value was no greater than 5%.
Result/Outcome/Range –
Positive/Negative/Inconclusive
Validation-Active Information:
- EQA: Yes
- Inter-laboratory validations
- Periodic according to validation schedule
- Event-triggered- Qc/Calibration/New materials/Batch
Accuracy
The accuracy of any of our diagnostic tests is defined as the combination of sensitivity and specificity variables. Sensitivity is the test’s ability to confirm positive results, specificity is the ability to eliminate negative results. All of the tests we offer are validated to a high degree of accuracy (up to 98.5%).
Variables
Accuracy can be affected by a variety of factors that cannot be controlled by our lab. Infection intensity, patient health, and quality of the sample which is dependent on the adherence to “home testing” procedures can all be factors that limit the results of the test. Although our tests 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 Neisseria gonorrhoeae PCR detection test can detect the presence of the Ureaplasma urealyticum bacteria to a high degree of accuracy. The test uses a Polymerase Chain Reaction (PCR) amplifying method to detect the presence of the pathogen.
Positive result
A positive result suggests the presence of bacteria in the sample, at the time of testing. Upon the receipt of 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 Neisseria gonorrhoeae 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. This means the test did not detect the presence of infection at the time of testing. Results should still be discussed with a healthcare provider while considering lifestyle and sexual history. If you are in contact with someone who tests positive for the disease or begins to present symptoms consistent with the disease, you should contact your GP.
Arnold Watson –
This health testing company definitely exceeded my expectations!
Sandra –
Good service
Victoria Hill –
Received the kit after 5 days and results after 2 days!!