AMPIPROBE^® Bacterial Vaginosis Assay Kit

Sensitive, specific and semi-quantitative qPCR assay for the detection of Bacterial Vaginosis



ENZ-GEN205-0100	100 tests	1,898.00 USD
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Sensitive, specific and semi-quantitative assay
Low-cost alternative to other methods of Bacterial Vaginosis detection
Compatible with most open qPCR platforms
Smaller sample input that allows remaining extracted samples to be used in other tests

The AMPIPROBE^® Bacterial Vaginosis (BV) Assay is a real-time PCR assay for the detection of Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp., Megasphaera spp., and BVAB2. The nucleotide sequences of the PCR primers have been optimized to target sequences within species-specific regions of the target genome. The BV primers have been designed using AMPIPROBE^® technology which incorporates reporter and quencher dyes into the primers. Target detection is based on fluorescence decay when successive rounds of amplification bring fluorophore and quencher-labeled primer pairs in close proximity resulting in FRET. Loss of fluorescence below a defined threshold in a particular channel indicates sample positivity for the corresponding BV species.
The AMPIPROBE^® BV Primer Mixes include primers for a ubiquitously conserved human housekeeping gene (human β-globin). Successful amplification of the internal control serves as an indicator of sample adequacy, extraction efficiency and successful amplification in each individual sample.
The AMPIPROBE^® Bacterial Vaginosis Assay is a two tube assay and contains two separate BV primer mixes. Both BV primer mixes must be run with each sample in order to determine the positive or negative status of the sample.

Product Details

Sensitivity:	In a validation study approved by the New York State Department of Health, the AMPIPROBE^® Bacterial Vaginosis Assay was determined to have a sensitivity of 84.30%.

Applications:	qPCR

Application Notes:	The AMPIPROBE^® Bacterial Vaginosis Assay is compatible with any properly calibrated qPCR thermal cycler capable to detect fluorescence decay. It has been validated for use on the QIAGEN Rotor-Gene Q

Species reactivity:	Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp., Megasphaera-1, BVAB-2

Specificity:	In a validation study approved by the New York State Department of Health, the AMPIPROBE^® Bacterial Vaginosis Assay was determined to have a specificity of 97.80%

Use/Stability:	All components are stable at -20°C until the kit's expiration date.

Shipping:	Dry Ice

Short Term Storage:	+4°C

Long Term Storage:	-20°C

Contents:	AMPIGENE^® HS Taq DNA Polymerase AMPIGENE^® dNTP Mix AMPIPROBE^® 5X Assay Buffer AMPIPROBE^® BV I Primer Mix AMPIPROBE^® BV II Primer Mix BV Control 1 BV Control 2 BV Control 3 No Template Control (NTC) Nuclease-free Water

Scientific Background:	Bacterial vaginosis (BV) is the most common vaginal infection in the United States and affects approximately 29% of women. BV complications include an increased risk to develop other sexually transmitted infections and an increased risk of infection after pelvic surgery. In addition, BV during pregnancy has been linked with adverse pregnancy outcomes including preterm labor and delivery, low birth weight, premature rupture of membranes, postpartum metritis and intra-amniotic infection. Clinical signs and symptoms (Amsel criteria) are often used to diagnose BV but the gold standard method for diagnosis is enumeration of bacterial morphotypes on a Gram-stained smear. Although the exact etiology of BV is still undetermined, the consensus is that it occurs when Lactobacillus spp., which normally comprising 90-95% of total bacteria in healthy vaginal flora, is replaced by anaerobes, mainly but not restricted to Gardnerella vaginalis. More recently, molecular detection of other microbes, that are mostly uncultureable, have been associated with BV including Atopobium vaginae, BVAB2, and Megasphaera spp.

Regulatory Status:	RUO - Research Use Only

General Literature References

The microbiota of the vagina and its influence on women’s health and disease: D.H. Martin; Am. J. Med. Sci. 343, 2 (2012), Abstract; Full Text

Targeted PCR for Detection of Vaginal Bacteria Associated with Bacterial Vaginosis: D.N. Fredricks, et al.; J. Clin. Microbiol. 45, 3270 (2007), Abstract; Full Text

Vulvovaginal candidosis: J.D. Sobel; Lancet 369, 1961 (2007), Abstract;

Molecular identification of bacteria associated with bacterial vaginosis: D.N. Fredricks, et al.; N. Engl. J. Med. 353, 1899 (2005), Abstract; Full Text

Evaluation of vaginal complaints: M.R. Anderson, et al.; JAMA 291, 1368 (2004), Abstract;

Bacterial vaginosis in early pregnancy and pregnancy outcome: T. Kurki, et al.; Obstet. Gynecol. 80, 173 (1992 ), Abstract;

Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation: R.P. Nugent, et al.; J. Clin. Microbiol. 29, 297 (1991), Abstract;

Independent associations of bacterial vaginosis and Chlamydia trachomatis infection with adverse pregnancy outcome: M.G. Gravett, et al.; JAMA 256, 1899 (1986), Abstract;

Diagnosis of bacterial vaginosis by direct gram stain of vaginal fluid: C.A. Spiegel, et al.; J. Clin. Microbiol. 18, 170 (1983), Abstract;

Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations: R. Amsel, et al.; Am. J. Med. 74, 14 (1983), Abstract;

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