What is the Scientific Data from the Instrument and Reagent Supplier?
Technology Method:
Polymerase Chain Reaction (PCR)
Limit of Detection:
NEISSERIA GONNORHOEAE/ CHLAMYDIA TRACHOMATIS/ U. UREALYTICUM:
1×104 CFU/mL, 5×102 IFU/mL, 1×104 CFU/mL , respectively.
Sensitivity:
Firstly, the positive and negative coincidence rates in the STI kit’s positive and negative reference controls were 100%.
Specificity:
No cross-reactivity of the kit between the virus was observed.
Accuracy:
Also, precision reference controls were tested 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
Importantly, the accuracy of any of our diagnostic methods is defined as the combination of sensitivity and specificity variables. Sensitivity is the ability to confirm positive results; specificity eliminates negative results. Furthermore, all our methods are validated with high accuracy (up to 98.5%).
Variables
Accuracy can be affected by various factors that our lab cannot control. Virus intensity, patient health, and sample quality, dependent on adherence to “home testing” procedures, can all limit the results. Although our methods are extremely sensitive, a poor-quality swab makes it harder to detect the presence of the virus or bacteria, as fewer particles will be present. Please carefully consider the information sheet accompanying your sample collection kit to ensure a high-quality sample.
Detection
The 3-in-1 profile PCR detection system accurately checks the presence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Ureaplasma urealyticum bacteria in the sample. It can accurately distinguish between the presence of each of these common STIs.
Any diagnosis should be discussed with your GP. Results from the Medicines By Mailbox screening laboratory are intended to be viewed with a patient’s history, diet, genetics, lifestyle, and other factors that may influence results, which should be shared when discussing these results.
Positive result
A positive result suggests the presence of viral particles in the sample during processing.
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. Therefore, results should still be discussed with a GP while considering lifestyle and history.
Swab/Tub
Chlamydia PCR
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The kits were user-friendly and easy to use. Made the whole process convenient and accessible!
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The price is very affordable
Rick Fisher –
There were some issues with royal mail, but the rest went well
Bruno –
I usually do the markers once a year and I like to do it with online medicines, because I can do it from outside and the results come back fast