What is the Scientific Data from the Instrument and Reagent Supplier?
Accuracy
The accuracy of a diagnostic STD test is the combination of two factors: sensitivity and specificity. Sensitivity is the ability to confirm positive results, while specificity eliminates negative results. Furthermore, all of our STI methods are validated to a high degree of accuracy – up to 98.5%.
Variables
Accuracy can be affected by various factors that our lab cannot control. Bacteria or viral intensity, patient health, and sample quality, such as adherence to the “home sampling” procedure, can all limit the results. Although our PCR methods are extremely sensitive, a poor-quality swab makes it harder to detect the presence, as fewer viral/bacterial particles will be present. However, please carefully consider the information in your sample collection kit to ensure a high-quality sample.
The full Profile
Multiple PCR detection methods are carried out to investigate the presence of up to 8 of the most common S and ensure accuracy. The sample will not only return results for each of these samples separately, but if positive, it will further clarify which strain(s) are detected for HPV or Herpes Simplex Virus (HSV).
Discussing results with your GP
Any diagnosis should be discussed with your healthcare provider. However, results from the Medicines Online 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 with your GP when discussing them.
Positive result
If you receive a positive result, please get in touch with your GP for a cure. A positive result indicates the presence in the body. However, this does not necessarily mean it will manifest symptoms. The HPV types are for are those linked with a higher risk of cervical cancer and, as such, should be discussed with your GP.
Negative result
While this is a reassurance, it is important to understand its significance. This means the test did not detect the presence when testing for the variants. It may still develop after the sample is taken or has cleared by the time it was taken. Safe practices can help to mitigate such risks.
The HPV check includes those variants most strongly linked to cervical cancer, but it is unable to detect if you are positive for one of the other 200+ variants.
If you have HPV, it is not an indicator of the cytologic high-grade squamous intraepithelial lesion (HSIL) or underlying high-grade cervical intraepithelial neoplasia (CIN), nor does it imply that a CIN 2-3 cancer will develop. However, most women with one or more high-risk HPV types do not develop CIN 2-3 or cancer.
Scientific Data:
CHLAMYDIA TRACHOMATIS
Technology Method:
Polymerase Chain Reaction (PCR)
Limit of Detection:
5 x 102 IFU/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 materials was observed.
Accuracy:
Precision reference controls were processed 10 times, and the Ct value’s coefficient of variation (CV,%) was no greater than 5%.
Result/Outcome/Range –
Positive/Negative/Inconclusive
Interlaboratory Validation
Yes
Internal Cross-Instrument Comparisons
N/A
For more data on specific items, please visit the website product page.
Self Swab/Urine
Chlamydia PCR
