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WOMEN'S HEALTH AND STI

IVD Molecular Controls


Your laboratory is committed to elevating the standard of care for women’s health and sexually transmitted infections (STIs) with advanced diagnostic technologies. When it comes to QC testing your molecular methods, you should expect the same level of quality. Microbiologics offers a variety of IVD controls for women’s health and STI testing featuring room temperature storage and formats that mimic patient sample processing for ease of use.

We offer Helix Elite™ molecular controls for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, HPV - Human Papillomavirus, and more!

SIMPLE, ACCURATE, RELIABLE CONTROLS

  • Fully intact microorganisms inactivated to make them noninfectious
  • Compatible with a variety of instruments, kits, and applications
  • Independent external controls provide accurate, reliable results
  • Convenient test-ready formats save you time and money
  • Easy and economical storage, no freezing required
  • Certificate of Analysis provides detailed strain information
  • Technical Support experts available for guidance

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QC Sets and Panels

The Bacterial vaginosis (BV) Control Panel contains six inactivated pre-pooled positive control pellets and 6 inactivated negative control pellets comprised of the organisms listed below (12 vials/pellets total).


Positive control (six vials/pellets):

  • Atopobium vaginae
  • Gardnerella vaginalis

Negative control (six vials/pellets):

  • Lactobacillus crispatus

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The Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel contains six inactivated pre-pooled positive control 1 pellets and 6 inactivated pre-pooled positive control 2 pellets comprised of the organisms listed below (12 vials/pellets total).


Positive control (six vials/pellets):

  • Candida albicans
  • Candida glabrata

Negative control (six vials/pellets):

  • Trichomonas vaginalis

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Contains six pre-pooled positive and six negative, inactivated control swabs (12 swabs/kit) comprised of the microorganisms listed below. For use with Cepheid CT/NG assay.


Positive control (six swabs/kit):

  • Chlamydia trachomatis
  • Neisseria gonorrhoeae

Negative control (six swabs/kit):

  • Human cells

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Contains six inactivated, pre-pooled pellets comprised of the microorganisms listed below (six pellets/kit):


  • Chlamydia trachomatis
  • Neisseria gonorrhoeae
  • Trichomonas vaginalis

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Contains six pre-pooled positive and six negative, inactivated control swabs (12 swabs/kit) comprised of the microorganisms listed below.


Positive control (six swabs/kit):

  • Chlamydia trachomatis
  • Neisseria gonorrhoeae

Negative control (six swabs/kit):

  • Human Cells

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Contains six positive and six negative, inactivated control swabs (12 swabs/kit) comprised of the microorganisms listed below.


Positive control (six swabs/kit):

  • Streptococcus agalactiae

Negative control (six swabs/kit):

  • Lactobacillus acidophilus

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Contains six inactivated pre-pooled positive control swabs, and six inactivated negative control swabs (12 swabs total):



Positive control (six swabs/kit):

  • Atopobium vaginae
  • BVAB2 surrogate
  • Candida albicans
  • Candida glabrata
  • Trichomonas vaginalis

Negative control (six swabs/kit):

  • Lactobacillus acidophilus

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Contains two inactivated positive control 1 swabs, two inactivated positive control 2 swabs, two inactivated positive control 3 swabs, two inactivated positive control 4 swabs and two inactivated negative control swabs (10 swabs total) :



Positive control 1 (two swabs/kit):

  • Atopobium vaginae
  • BVAB2 surrogate

Positive control 2 (two swabs/kit):

  • Candida albicans

Positive control 3 (two swabs/kit):

  • Candida glabrata

Positive control 4 (two swabs/kit):

  • Trichomonas vaginalis

Negative control (two swabs/kit):

  • Lactobacillus acidophilus

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Contains 20 inactivated, pre-pooled pellets comprised of human cells and the microorganisms listed below (20 pellets/kit):


  • HPV 16 gene target E6/E7 and L1
  • HPV 18 gene target E6/E7 and L1
  • HPV 31 gene target E6/E7 and L1
  • HPV 45 gene target E6/E7 and L1
  • HPV 68 gene target E6/E7 and L1
  • Human Cells

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Contains six inactivated, pre-pooled pellets comprised of human cells and the microorganisms listed below (six pellets/kit):


  • HPV 16 gene target E6/E7 and L1
  • HPV 18 gene target E6/E7 and L1
  • HPV 31 gene target E6/E7 and L1
  • HPV 45 gene target E6/E7 and L1
  • HPV 68 gene target E6/E7 and L1
  • Human Cells

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Contains six inactivated pre-pooled positive control swabs, and six inactivated negative control swabs (12 swabs total).


Positive control (six swabs/kit)

  • Streptococcus agalactiae

Negative control (six swabs/kit)

  • Lactobacillus acidophilus
  • Escherichia coli surrogate for sample adequacy control

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Contains 10 inactivated pre-pooled positive control swabs, and 10 inactivated negative control swabs (20 swabs total).


Positive control (10 swabs/kit)

  • Streptococcus agalactiae

Negative control (10 swabs/kit)

  • Lactobacillus acidophilus
  • Escherichia coli surrogate for sample adequacy control

More Details

Contains six positive and six negative, inactivated control swabs (12 swabs/kit) comprised of the microorganisms listed below.


Positive control (six swabs/kit):

  • Streptococcus agalactiae

Negative control (six swabs/kit):

  • Lactobacillus acidophilus

More Details

Contains six positive (pre-pooled) and six negative inactivated control swabs (12 swabs/kit) comprised of the strains listed below.


Positive control (six swabs/kit):

  • Trichomonas vaginalis
  • Human cells

Negative control (six swabs/kit):

  • Neisseria gonorrhoeae
  • Human cells

More Details

Contains six inactivated, pre-pooled microorganism pellets of each pool listed below (12 pellets/kit).


Pool 1 (six pellets/kit)

  • Lactobacillus crispatus

Pool 2 (six pellets/kit)

  • Atopobium vaginae
  • Candida albicans
  • Candida glabrata
  • Candida krusei
  • Gardnerella vaginalis
  • BVAB2 surrogate
  • Trichomonas vaginalis

More Details

Includes two boxes containing 20 individually packaged inactivated microorganism pellets of each pool listed below (120 pellets/kit).


Pool 1 (20 pellets/kit)

  • Lactobacillus crispatus

Pool 2 (20 pellets/kit)

  • Gardnerella vaginalis

Pool 3 (20 pellets/kit)

  • Atopobium vaginae
  • Candida albicans
  • Gardnerella vaginalis
  • BVAB2 surrogate

Pool 4 (20 pellets/kit)

  • Atopobium vaginae
  • Gardnerella vaginalis
  • BVAB2 surrogate
  • Trichomonas vaginalis

Pool 5 (20 pellets/kit)

  • Atopobium vaginae
  • Candida glabrata
  • Gardnerella vaginalis
  • Lactobacillus crispatus

Pool 6 (20 pellets/kit)

  • Atopobium vaginae
  • Candida glabrata
  • Gardnerella vaginalis
  • Lactobacillus crispatus

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Helix Elite™ Molecular Standards

Inactivated Helix Elite™

Each kit contains five unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.


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Each kit contains five unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.


More Details

Each kit contains five unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.


More Details

Each kit contains five unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.


More Details

Each kit contains five unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.


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Each kit contains five unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.


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Negative Helix Elite™

Each kit contains five individually packaged lyophilized pellets that contain human lung epithelial cells.


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Each kit contains six individually packaged lyophilized swabs that contain human lung epithelial cells.


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