Digital Image Analysis for the Detection of Group B Streptococcus from ChromID Strepto B Medium Using PhenoMatrix Algorithms

Group B Streptococcus (GBS) can be found to colonize about 25% of all healthy, adult women and is the leading infectious cause of early neonatal morbidity and mortality in the United States. This study evaluated the clinical performance of PhenoMatrix (PM) chromogenic detection module (CDM) digital imaging software in detection of GBS from LIM broth plated on ChromID Strepto B chromogenic medium (ChromID) using the WASP automated processor. The performance of the PM CDM was compared to manual culture review of the digital images and molecular detection of GBS. ChromID alone had a sensitivity and specificity of 84.5% and 94.7%, respectively, after 48 h compared to nucleic acid amplification testing (NAAT). Compared to the composite reference for positivity, when PM CDM was used to detect GBS from ChromID, the sensitivity was 100%, with no true-positive GBS isolates missed by 48 h of incubation. Overall, evaluating all three methods for the detection of GBS, the sensitivities of NAAT, ChromID plus PM CDM at 48 h, and ChromID alone at 48 h were 96.8%, 95.5%, and 90.3%, respectively. The specificities of NAAT, ChromID plus PM CDM, and ChromID alone were 97.7%, 63.0%, and 95.4%, respectively. The sensitivity of ChromID in combination with the PM CDM was similar to the sensitivity of molecular detection. Further, the algorithm never called a culture negative that was determined to be positive by manual reading, and it identified an additional eight true positive specimens that were missed by manual digital image culture reading.

Automated summary

This study evaluated the clinical performance of PhenoMatrix (PM) chromogenic detection module (CDM) digital imaging software in detecting Group B Streptococcus (GBS), which is the leading infectious cause of early neonatal morbidity and mortality. Compared to traditional methods like manual culture review and molecular detection, the combination of ChromID with PM CDM showed similar sensitivity to molecular detection and identified additional true positive specimens missed by manual reading. Overall, nucleic acid amplification testing (NAAT) had the highest sensitivity in GBS detection, with ChromID plus PM CDM showing comparable sensitivity and ability to detect missed true positive specimens.