Integrated Method for Collection and Maintenance of Detectability of a Plurality of Microbiological Agents in a Single Clinical Sample and for Handling a Plurality of Samples for Reporting a Sum of Diagnostic Results for Each Sample

Abstract

A method and kit related thereto are described for the collection and maintenance of detectability of a plurality of species of microbiological agents in a single clinical sample as well as an integral method for handling a plurality of the samples and managing information associated therewith for reporting a sum of diagnostic results for each sample.

1 . A method for receiving and handling at least one swab of a gynecological specimen from a patient, said method comprising:
 receiving said at least one swab disposed in a medium for maintaining detectability of two or more microbiological agents in said gynecological specimen; and   testing DNA from said medium for validation of the existence of said two or more microbiological agents comprising at least one of  Atopobium vaginae, Candida krusei , erythromycin-resistant  Streptococcus agalactiae , and clindamycin-resistant  Streptococcus agalactiae.      
     
     
         2 . The method of  claim 1 , wherein said two or more microbiological agents comprise at least  Atopobium vaginae  and a second agent comprising at least one of Molluscum contagiosum virus,  Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida krusei, Candida lusitaneae , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         3 . The method of  claim 2 , wherein said second agent comprises at least one of  Candida krusei , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae , HPV-16, or HPV-18. 
     
     
         4 . The method of  claim 2 , wherein said second agent also comprises at least one of  Chlamydia trachomatis, Neisseria gonorrhoeae, Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Bacteroides fragilis, Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, Ureaplasma urealyticum , at least one of Herpes simplex virus,  Treponema pallidum , or  Haemophilis ducreyi.    
     
     
         5 . The method of  claim 1 , further comprising: extracting said DNA from said medium. 
     
     
         6 . The method of  claim 1 , further comprising: amplifying said DNA. 
     
     
         7 . The method of  claim 6 , wherein said amplifying comprises real-time Polymerase Chain Reaction (PCR). 
     
     
         8 . The method of  claim 1 , further comprising: providing a kit containing said swab and said medium. 
     
     
         9 . The method of  claim 1 , further comprising: culturing at least one of said two or more microbiological agents. 
     
     
         10 . A method for receiving and handling at least one swab of a gynecological specimen from a patient, said method comprising:
 receiving said at least one swab disposed in a medium for maintaining detectability of two or more microbiological agents in said gynecological specimen; and   testing DNA from said medium for validation of the existence of said two or more microbiological agents comprising at least  Atopobium vaginae.      
     
     
         11 . The method of  claim 10 , wherein said two or more microbiological agents comprises a second agent comprising at least one of  Chlamydia trachomatis, Neisseria gonorrhoeae, Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Bacteroides fragilis, Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, Candida dubliniensis, Candida krusei, Candida lusitaneae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Treponema pallidum, Haemophilis ducreyi, Molluscum contagiosum  Virus, erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , and Human papillomavirus (HPV). 
     
     
         12 . The method of  claim 11 , wherein said second agent comprises at least one of Molluscum contagiosum virus,  Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida krusei, Candida lusitaneae , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         13 . The method of  claim 12 , wherein said second agent comprises at least one of  Candida krusei , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae , HPV-16, or HPV-18. 
     
     
         14 . A method for receiving and handling at least one swab of a gynecological specimen from a patient, said method comprising:
 receiving said at least one swab disposed in a medium for maintaining detectability of two or more microbiological agents in said gynecological specimen; and   testing DNA from said medium for validation of the existence of said two or more microbiological agents comprising at least one of  Candida krusei , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae.      
     
     
         15 . The method of  claim 14 , wherein said two or more microbiological agents comprises a second agent comprising at least one of  Atopobium vaginae, Chlamydia trachomatis, Neisseria gonorrhoeae, Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Bacteroides fragilis, Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, Candida dubliniensis, Candida lusitaneae, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Treponema pallidum, Haemophilis ducreyi , Molluscum contagiosum Virus,  Lymphogranuloma venereum , and Human papillomavirus (HPV). 
     
     
         16 . The method of  claim 15 , wherein said two or more microbiological agents comprises at least  Candida krusei , and said second agent comprises at least one of  Atopobium vaginae, Molluscum contagiosum virus, Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida lusitaneae , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         17 . The method of  claim 15 , wherein said two or more microbiological agents comprise at least erythromycin-resistant  Streptococcus agalactiae , and said second agent comprises at least one of  Atopobium vaginae, Molluscum contagiosum virus, Mycoplasma genitalium, Mycoplasma hominis, Candida krusei Candida dubliniensis, Candida lusitaneae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         18 . The method of  claim 15 , wherein said second agent comprises at least one of clindamycin-resistant  Streptococcus agalactiae , and said second agent comprises at least one of at least one of  Atopobium vaginae, Molluscum contagiosum virus, Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida krusei, Candida lusitaneae , erythromycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         19 . The method of  claim 14 , wherein said two or more microbiological agents comprises a second agent comprising at least one of  Atopobium vaginae , HPV-16 or HPV-18. 
     
     
         20 . A kit for facilitating the handling of at least one swab of a gynecological specimen from a patient, said kit comprising:
 at least one swab;   a medium for receiving said swab after said gynecological specimen has been collected and for maintaining the detectability of two or more microbiological agents in said gynecological specimen; and   a test requisition form listing two or more microbiological agents for validation, said two or more microbiological agents comprising at least one of  Atopobium vaginae, Candida krusei , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae.      
     
     
         21 . The kit of  claim 20 , wherein said two or more microbiological agents comprise at least  Atopobium vaginae  and a second agent comprising at least one of Molluscum contagiosum virus,  Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida krusei, Candida lusitaneae , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         22 . The kit of  claim 21 , wherein said second agent comprises at least one of  Candida krusei , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae , HPV-16, or HPV-18. 
     
     
         23 . The kit of  claim 21 , wherein said second agent also comprises at least one of  Chlamydia trachomatis, Neisseria gonorrhoeae, Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, Bacteroides fragilis, Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, Ureaplasma urealyticum , at least one of Herpes simplex virus,  Treponema pallidum , or  Haemophilis ducreyi.    
     
     
         24 . The kit of  claim 20 , wherein said two or more microbiological agents comprises at least  Candida krusei , and said second agent comprises at least one of  Atopobium vaginae , Molluscum contagiosum virus,  Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida lusitaneae , erythromycin-resistant  Streptococcus agalactiae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         25 . The kit of  claim 20 , wherein said two or more microbiological agents comprise at least erythromycin-resistant  Streptococcus agalactiae , and said second agent comprises at least one of  Atopobium vaginae , Molluscum contagiosum virus,  Mycoplasma genitalium, Mycoplasma hominis, Candida krusei Candida dubliniensis, Candida lusitaneae , clindamycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44. 
     
     
         26 . The kit of  claim 20 , wherein said second agent comprises at least one of clindamycin-resistant  Streptococcus agalactiae , and said second agent comprises at least one of at least one of  Atopobium vaginae , Molluscum contagiosum virus,  Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida krusei, Candida lusitaneae , erythromycin-resistant  Streptococcus agalactiae, Lymphogranuloma venereum , HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, HPV-66, HPV-68, HPV-6/11, HPV-42, HPV-43, and HPV-44.