What is the Scientific Data from the Instrument and Reagent Supplier?
Technology Method:
Polymerase Chain Reaction (PCR)
Limit of Detection:
Type I: 324 copies/mL. Type II: 404 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 virus 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
HSV Type I, HSV Type II
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 Herpes diagnostic exams is defined as the combination of sensitivity and specificity variables. Sensitivity is the method’s ability to confirm positive results; specificity eliminates negative results. 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. Viral intensity, patient health, and sample quality, dependent on adherence to “home sampling” procedures, can all limit the results. Although our PCR processes are extremely sensitive, a poor-quality swab makes it harder to detect the presence of the virus, as fewer viral particles will be present. Please carefully consider the information sheet accompanying your sample collection kit to ensure a high-quality sample.
Virus Detection
The HSV PCR kit is designed to detect the presence of the virus in the sample accurately. A positive result distinguishes between Type I and Type II or if both types are present in the sample.
Any diagnosis should be discussed with your GP. Any results from our medical diagnostics laboratory are intended to be viewed by your GP. This can be done with the patient’s medical history, lifestyle, and other factors that may influence the results, which should be shared with your GP when discussing results.
Positive result
A positive result suggests the presence of viral particles in the sample during sampling. Upon receiving positive results, you should contact your GP for a cure. The method may detect the Herpes Simplex Virus, and even though the patient does not present symptoms, you may still transmit it to others.
Negative result
While this can provide reassurance, it is important to understand its significance. However, this means the process did not detect the presence of the virus during sampling. Results should still be discussed with a GP while considering lifestyle. If you are in contact with someone who is positive for the virus or begins to present symptoms consistently, you should contact your GP.
Swab Stick or Tub Option
Type 1 and 2 PCR
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