Loop-mediated isothermal amplification assay for rapid detection of Streptococcus agalactiae (group B streptococcus) in vaginal swabs - a proof of concept study

J Med Microbiol. 2017 Mar;66(3):294-300. doi: 10.1099/jmm.0.000437. Epub 2017 Mar 23.


Purpose: Neonatal sepsis caused by Streptococcus agalactiae [group B streptococcus (GBS)] is a life-threatening condition, which is preventable if colonized mothers are identified and given antibiotic prophylaxis during labour. Conventional culture is time consuming and unreliable, and many available non-culture diagnostics are too complex to implement routinely at point of care. Loop-mediated isothermal amplification (LAMP) is a method that, enables the rapid and specific detection of target nucleic acid sequences in clinical materials without the requirement for extensive sample preparation.

Methodology: A prototype LAMP assay targeting GBS sip gene is described.

Results: The assay was 100 % specific for GBS, with a limit of detection of 14 genome copies per reaction. The clinical utility of the LAMP assay for rapid direct molecular detection of GBS was determined by testing a total of 157 vaginal swabs with minimal sample processing using a rapid lysis solution. Compared to a reference quantitative real-time PCR assay, the direct LAMP protocol had a sensitivity and specificity of 95.4 and 100 %, respectively, with positive and negative predictive values of 100 and 98.3 %, respectively. Positive and negative likelihood ratios were infinity and 0.05, respectively. The direct LAMP method required a mean time of 45 min from the receipt of a swab to generation of a confirmed result, compared to 2 h 30 min for the reference quantitative real-time PCR test.

Conclusion: The direct LAMP protocol described is easy to perform, facilitating rapid and accurate detection of GBS in vaginal swabs. This test has a potential for use at point of care.

MeSH terms

  • Antigens, Bacterial / genetics
  • DNA Primers
  • Data Accuracy
  • Female
  • Genome, Bacterial
  • Humans
  • Nucleic Acid Amplification Techniques / methods*
  • Point-of-Care Systems
  • Real-Time Polymerase Chain Reaction / methods
  • Sensitivity and Specificity
  • Streptococcal Infections / diagnosis*
  • Streptococcal Infections / microbiology
  • Streptococcus agalactiae / genetics
  • Streptococcus agalactiae / isolation & purification*
  • Temperature
  • Vagina / microbiology*


  • Antigens, Bacterial
  • DNA Primers
  • SIP protein, Streptococcus group B