Gardnerella vaginalis/Lactobacillus species RT-PCR Quant (CE) | R-B7-FRT

Gardnerella vaginalis/Lactobacillus species RT-PCR Quant (CE) | R-B7-FRT from Sacace Biotechnologies is available for delivery

Real Time Kit PCR kit for quantitative detection of Gardnerella vaginalis and Lactobacillus spp.

Storage & Shipping :

The kit can be shipped at 2-8°C for 3-4 days but should be stored at 2-8°C and -20°C immediately on receipt.

Gardnerella vaginalis/Lactobacillus species RT-PCR Quant (CE) R-B7-FRT DataSheet

INTRODUCTION

STDs (sexually transmitted diseases) refer to a variety of bacterial, viral and parasitic infections that are acquired through sexual activity. Some STDs, such as syphilis and gonorrhea, have been known for centuries — while others, such as HIV, have been identified only in the past few decades. STDs are caused by more than 25 infectious organisms. As more organisms are identified, the number of STDs continues to expand. Common STDs include: chlamydia, gon[1]orrhea, herpes, HIV, HPV, syphilis, mycoplasma, gardnerella and trichomoniasis.

The development of tests based on nucleic acid amplification technology has been the most important advance in the field of STD diagnosis. Because nucleic acid amplification is exquisitely sensitive and highly specific, it offers the opportunity to use noninvasive sampling techniques to screen for infections in asymptomatic individuals who would not ordinarily seek clinical care.

INTENDED USE

kit Gardnerella vaginalis/Lactobacillus species Real-TM Quant is an in vitro Real Time amplification test for quantitative detection of Gardnerella vaginalis and Lactobacillus spp. This kit allows to estimate the conditions of vaginal flora and to give with high accuracy the diagnosis of Bacterial vaginosis (BV). Bacterial vaginosis (BV) is considered to be the most common cause of vaginal inflammation among both pregnant and non-pregnant women and prevalences between 4.9% and 36.0% have been reported from European and American studies. It previously was called nonspecific vaginitis or Gardnerella-associated vaginitis.

The adult human vagina is a complex ecosystem containing an abundance of microorganisms. In women of childbearing age this system is dominated by Lactobacillus spp., a genus of gram[1]positive, nonmotile rod-like bacteria, a defining characteristic of which is the ability to grow in acid media and tolerate acid conditions (pH < 4.5); lactobacilli also ferment carbohydrates to produce lactic acid and produce H2O2 which provides a natural defense against Gardnerella vaginalis. In bacterial vaginosis (BV) the balance of flora is changed with reduced numbers of lactobacilli (normal concentration 106 – 1010 CFU/ml) and an increase in numbers of other facultative and anaerobic species such as anaerobic cocci Prevotella spp., Gardnerella vaginalis, and Mobiluncus spp. (normal concentration < 103-105 CFU/ml). G. vaginalis is virtually always present at high concentrations in women who have BV but is also detected frequently in normal women and in some cases the concentration of Gardnerella vaginalis can reach 107-108 CFU/ml also in absence of BV, so the most important maker of BV is the ratio of logarithm concentration Lactobacillus spp and G. vaginalis.

PRINCIPLE OF ASSAY

kit Gardnerella vaginalis/Lactobacillus species Real-TM Quant is based on two major processes: isolation of DNA from specimens and multiplex Real Time amplification. Amplification results of Gardnerella vaginalis are detected on the Fam/Green channel, amplification results of Lactobacillus spp are detected on the Joe/HEX/Yellow channel. For quantification of the DNA of Lactobacillus spp and Gardnerella vaginalis all calibrators should be used and defined as standards with specific concentrations.

To calculate the concentration of the DNA of Lactobacillus spp and Gardnerella vaginalis in 1 ml of clinical material use the following formula:

CDNA Gv/ml = CDNA Gv x coefficient

CDNA L.spp/ml = CDNA L.spp x coefficient,

where,

CDNA Gv/ml = copies of the DNA Gardnerella vaginalis/reaction

CDNA L.spp/ml= copies of the DNA Lactobacillus spp/reaction

Coefficient = 100 – takes into account the volume of DNA in the reaction tube from the volume of the clinical material and the quantity of copies of the amplified gene in the genome of the microorganism.

The following equation has to be applied to calculation of the ratio of the concentration DNA Lactobacillus spp and DNA Gardnerella vaginalis:

RC Lsp-Gv = lg[C DNA Lspp/ml] – lg[C DNA Gv/ml]

RC < -1,0 – high possibility of BV

RC > 2.0 – low possibility of BV