AMPIPROBE^® Bacterial Vaginosis Extraction Controls

The AMPIPROBE^® Bacterial Vaginosis Extraction Controls are designed to ensure an efficient genomic DNA extraction process and detection of Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp., Megasphaera spp., and BVAB2.



ENZ-GEN206-0500	500 µl	265.00 USD
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Compatible with manual and automated DNA extraction methods
Compatible with most open qPCR platforms

The AMPIPROBE^® Candida Extraction Controls are designed to be used during the genomic DNA extraction of Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp., Megasphaera spp., and BVAB2.
All performance specifications must be validated by end-user and will vary based on chosen extraction methods. Eluent from extraction can be used as extraction control for AMPIPROBE^® Bacterial Vaginosis Assay kit (Prod. No. ENZ-GEN205).
Plasmids in Extraction Controls are present at higher concentrations compared to assay controls included in the qPCR kit. Extra care should be taken to avoid contamination.

Product Details

Applications:	qPCR

Application Notes:	The AMPIPROBE^® Bacterial Vaginosis Extraction Controls is compatible with manual and automated DNA extraction methods as well as any properly calibrated qPCR thermal cycler capable to detect fluorescence decay. It has been validated for use on the QIAGEN QIAsymphony SP and Rotor-Gene Q.

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

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:	Negative Extraction Control BV Positive Extraction Control No BV Target Control

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..

Protocol:	SETUP of DNA Extraction control The procedure described below is optimized for the QIAsymphony SP instrument (Qiagen) starting from an AMPTIMA^® Multitest Swab Specimen collection tube. Once thawed at room temperature, the AMPIPROBE Extraction Control tubes may be prepared. Label three 2.0 mL sample tubes with the appropriate control type (PC, NC, No BV Target), and then add 1.0 mL of blank APTIMA media to each tube. Next, add 25 µL of each AMPIPROBE Extraction Control into their associated, labelled 2.0 mL tube. The extraction controls are now prepared and ready for use. Continue extraction procedure same as patient samples. PCR SETUP Please refer to the PCR SETUP protocol present in Product Manual AMPIPROBE® Bacterial Vagnosis Assay Kit (Catalog #: ENZ-GEN205-0100, 100 Assays) and treat BV Positive Extraction Control, No BV Target Control and Negative Extraction controls as Samples. Note: The reagents required for the PCR Master Mix provided in the AMPIROBE® Bacterial Vaginosis Assay kit will be sufficient to run also the Bacterial Vaginosis Extraction Controls.

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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