We would like to inform you about changes of result interpretation of «AmpliSens® Florocenosis / Bacterial vaginosis-FRT» PCR-kit. For data interpretation three ratio coefficients RC1, RC2 and RC3 are used instead of two RC1 and RC2 in previous version of software. All coefficients are calculated automatically by AmpliSens Florocenosis / Bacterial vaginosis software.
Definitions of results were changed according to European classification:
|Classification before March 11, 2013||Classification from April 1, 2013|
|Anaerobic dysbiosis (bacterial vaginosis)||The ratio of concentrations of microorganisms DNA corresponds to bacterial vaginosis|
|Normocenosis||According to the ratio of concentrations of microorganisms DNA the bacterial vaginosis is not detected|
|Mesocenosis||The ratio of concentrations of microorganisms DNA corresponds to the intermediate condition of microflora|
|Dysbiosis of undefined origin||The ratio of concentrations of microorganisms DNA corresponds to dysbiosis of unspecified ethiology|
Due to modification of results interpretation the following changes were made:
- Diagnostic sensitivity of PCR kit was increased.
- The quantity of unreliable results was decreased due to change of validity result threshold from 106 copies/ml to 105 copies/ml.
- The quantity of results «The ratio of concentrations of microorganisms DNA corresponds to the intermediate condition of microflora» was decreased.
- Additionally the following definition were added: «The decrease of the degree of bacterial content» (in case of the concentration of Lactobacillus spp. not less than full amount of bacterium, and the full amount of Bacteria DNA not less than 106 copies/ml and more than 105 copies/ml)
The above-mentioned changes were made in the software, which will be supplied with new series of sets of reagents.