AccuProbe culture identification tests

AccuProbe culture identification products are tools for the identification of mycobacterial, fungal and bacterial pathogens, with sensitivities and specificities approaching 100% in most cases. These products allow for the detection of target organisms from primary cultures, eliminating the additional labor of purifying secondary cultures. 

About

Hologic offers a full range of culture identification assays. These highly accurate tests screen for a wide variety of conditions and provide early identification of conditions that can help save lives. Results are obtained by utilizing luminometers for precise, easy-to-acquire readings. Convenient packaging of the AccuProbe assays also provides extended stability and shelf life.

Products

AccuProbe molecular diagnostic tests include:

Bacterial culture identification 

  • The AccuProbe Listeria monocytogenes culture identification test
  • The AccuProbe Neisseria gonorrhoeae culture identification test 
  • The AccuProbe Staphylococcus aureus culture identification test 
  • The AccuProbe Streptococcus pneumoniae culture identification test

Fungal culture identification

  • The AccuProbe Blastomyces dermatitidis culture identification test 
  • The AccuProbe Coccidioides immitis culture identification test
  • The AccuProbe Histoplasma capsulatum culture identification test

Mycobacterial culture identification

  • The AccuProbe Mycobacterium tuberculosis complex culture identification test
  • The AccuProbe Mycobacterium avium culture identification test
  • The AccuProbe Mycobacterium intracellulare culture identification test
  • The AccuProbe Mycobacterium avium complex culture identification test
  • The AccuProbe Mycobacterium gordonae complex culture identification test
  • The AccuProbe Mycobacterium kansasii complex culture identification test

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

 

 

Features

Unique features offered by the AccuProbe assays allow healthcare providers to:

  • Obtain accurate results.
  • Boost productivity by delivering definitive results in only 50 minutes.
  • Save time by using primary cultures.
  • Reduce technician training time by offering a user-friendly, non-isotopic test format.
  •  Hold down costs by using standard reagents for efficient batch testing.
Performance Data

High sensitivity and specificity
AccuProbe culture identification tests deliver high levels of sensitivity and specificity.

Bacterial Identification Sensitivity Specificity
Neisseria gonorrhoeae 100.0% 100.0%
Staphylococcus auresus 100.0% 100.0%
Listeria monocytogenes 100.0% 99.7%
Streptococcus pneumoniae 100.0% 100.0%
Fungal Identification Sensitivity Specificity
Blastomyces dermatitidis 98.1% 99.7%
Coccidiodes immitis 98.8% 100.0%
Histoplasma capsulatum 100.0% 100.0%
Mycobacterial Identification Sensitivity Specificity
Mycobacterium avium 99.3% 100.0%
Mycobacterium intracellulare 100.0% 100.0%
Mycobacterium avium complex 99.9% 100.0%
Mycobacterium gordonae 98.8% 99.7%
Mycobacterium kansasii 92.8% 100.0%
Mycobacterium tuberculosis complex 99.2% 99.0%

Please see package insert for detailed information.

 

Regulatory

Bacterial culture identification 

  • The AccuProbe Listeria monocytogenes culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Neisseria gonorrhoeae culture identification test was cleared for in vitro diagnostic use by the FDA in 1989.
  • The AccuProbe Staphylococcus aureus culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Streptococcus pneumoniae culture identification test was cleared for in vitro diagnostic use by the FDA in 1990. 

Fungal culture identification 

  • The AccuProbe Blastomyces dermatitidis culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Coccidioides immitis culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Histoplasma capsulatum culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.

Mycobacterial culture identification 

  • The AccuProbe Mycobacterium tuberculosis complex culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Mycobacterium avium culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Mycobacterium intracellulare culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Mycobacterium avium complex culture identification test was cleared for in vitro diagnostic use by the FDA in 1992.
  • The AccuProbe Mycobacterium gordonae complex culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.
  • The AccuProbe Mycobacterium kansasii complex culture identification test was cleared for in vitro diagnostic use by the FDA in 1990.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.