Verification of a molecular pathology detection method of sentinel lymph node in breast cancer patients:a comparison between RT-LAMP and GeneSearch / 军事医学

ABSTRACT

Objective To verify the reliability of our previously established reverse-transcription loop-mediated isother-mal amplification ( RT-LAMP) method for the detection of sentinel lymph nodes metastasis in breast cancer patients .Meth-ods Sentinel lymph nodes of breast cancer patients were analyzed by RT-LAMP and FDA-approved GeneSearch methods respectively, and the consistency of the two methods was assessed with a kappa concordance test.Results One hundred and thirty-four cases of sentinel lymph node samples were collected from seven hospitals in Beijing .Using the GeneSearch assay as the gold standard, the sensitivity, specificity and consistentcy of RT-LAMP were 96.2%(25/26),96.3%(104/108) and 96.3%(129/134), respectively.Statistical analysis showed that the two methods were consistent (Kappa=0.8857, P<0.001).Conclusion RT-LAMP is highly consistent with GeneSearch ,efficient,simple and inexpensive, promising a good prospect of application to intra-operative detection of sentinel lymph nodes metastasis for breast cancer patients.