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

• US 20070042355A1
• Filed: 01/31/2006
• Published: 02/22/2007
• Est. Priority Date: 02/10/2005
• Status: Active Grant

• Current Assignee: Medical Diagnostic Laboratories LLC
• Original Assignee: Medical Diagnostic Laboratories LLC
• Inventors: Mordechai, Eli, Adelson, Martin
• Granted Patent: US 9,464,310 B2
• Time in Patent Office: Days
• US Class Current: 435/5
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: C12Q 1/045 Culture media therefor
• CPC Class Codes: C12Q 1/689 for bacteria
• CPC Class Codes: C12Q 1/6893 for protozoa
• CPC Class Codes: C12Q 1/6895 for plants, fungi or algae
• CPC Class Codes: C12Q 1/705 for herpetoviridae, e.g. herpes simplex, varicella zoster
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

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.

Claims

1. A method for the collection and maintenance of detectability of a plurality of species of microbiological agents selected from the group consisting of bacteria, fungi, and viruses, in a single clinical sample and for handling a plurality of samples and managing information associated therewith for reporting a sum of diagnostic results for each sample comprising:

providing transport media in a resealable container with instructions for preparation and handling of a sample and an indication of the detectability of the plurality of species,

receiving a plurality of samples, each having identity and test requisition information associated therewith wherein the test requisition information indicates a test for at least one species from a plurality of species,

entering the information into a system to create a requisition file for each sample,

processing the information to create a list of samples to be tested for each species,

dispensing an aliquot corresponding to each sample into an individual vessel, to create a secondary sample, for each designated test for different species on each sample,

assembling a general supply of master reagent mix for each different test,

combining an aliquot of master reagent mix for each test with each corresponding secondary sample to produce a diagnostic test reaction for each secondary sample,

determining the presence or absence of a certain product of each reaction to produce a result,

recording the result of each reaction,

combining the result of each reaction derived from each primary sample into the requisition file for each sample on the system, thereby producing a sum of results for each sample, and

reporting the results,

wherein the plurality of species comprises at least one species selected from the group consisting of Molluscum contagiosum Virus, Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida krusei, Candida lusitaneae, Atopobium vaginae, 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.

2. The method according to claim 1 wherein at least one species within the plurality of species is indicative of at least one gynecological disorder.

3. The method according to claim 2 wherein at least one species within the plurality of species is selected from the group consisting of Bacteroides fragilis, Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, Chlamydia trachomatis, Gardnerella vaginalis, Haemophilis ducreyi, Herpes simplex virus subtype 1 (HSV-1), Herpes simplex virus subtype 2 (HSV-2), Human papillomavirus (HPV), Mobiluncus mulieris, Mobiluncus curtisii, Molluscum contagiosum Virus, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, Ureaplasma urealyticum, and Streptococcus agalactiae (Group B Streptococcus).

4. The method according to claim 3 wherein at least two species within the plurality of species are selected from the group.

5. The method according to claim 4 wherein at least three species within the plurality of species are selected from the group.

6. The method according to claim 5 wherein at least four species within the plurality of species are selected from the group.

7. The method according to claim 6 wherein at least five species within the plurality of species are selected from the group.

8. The method according to claim 7 wherein at least six species within the plurality of species are selected from the group.

9. The method according to claim 4 wherein the plurality of species comprise Chlamydia trachomatis and Neisseria gonorrhoeae.

10. The method according to claim 6 wherein the plurality of species comprise Gardnerella vaginalis, Mobiluncus mulieris, Mobiluncus curtisii, and Bacteroides fragilis.

11. The method according to claim 6 wherein the plurality of species comprise Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalis.

12. The method according to claim 5 wherein the plurality of species comprise Mycoplasma genitalium, Mycoplasma hominis, and Ureaplasma urealyticum.

13. The method according to claim 2 wherein the plurality of species comprise Herpes simplex virus, Treponema pallidum, and Haemophilis ducreyi.

14. The method according to claim 2 wherein at least one (1) species of the plurality of species is selected from the group consisting of Gardnerella vaginalis, Molluscum contagiosum Virus, Mycoplasma genitalium, and Mycoplasma hominis.

15. A method for the collection and maintenance of detectability of a plurality of species of microbiological agents selected from the group consisting of bacteria, fungi, and viruses, in a single gynecological sample and for handling a plurality of samples and managing information associated therewith for reporting a sum of diagnostic results for each sample comprising:

providing a kit comprised of transport media in a resealable container, a sterile swab, and instructions for preparation and handling of a gynecological sample and a writing which indicates the detectability of the plurality of species,

receiving a plurality of samples, each derived from the kit, having identity and test requisition information associated therewith wherein the test requisition information indicates a test for at least one species from the plurality of species,

entering the information into a system to create a requisition file for each sample,

processing the information to create a list of samples to be tested for each species,

dispensing an aliquot corresponding to each sample into an individual vessel, to create a secondary sample, for each designated test for different species on each sample,

assembling a general supply of master reagent mix for each different test,

combining an aliquot of master reagent mix for each test with each corresponding secondary sample to produce a diagnostic test reaction for each secondary sample,

determining the presence or absence of a certain product of each reaction to produce a result,

recording the result of each reaction,

combining the result of each reaction derived from each primary sample into the requisition file for each sample on the system, thereby producing a sum of results for each sample, and

reporting the results,

wherein the plurality of species comprises at least one species selected from the group consisting of Molluscum contagiosum Virus, Mycoplasma genitalium, Mycoplasma hominis, Candida dubliniensis, Candida krusei, Candida lusitaneae, Atopobium vaginae, 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.

16. The method according to claim 15 wherein the presence or absence of a product of at least one reaction is electronically recorded by means of the system.

17. The method according to claim 16 wherein at least one diagnostic test reaction comprises a real-time Polymerase Chain Reaction (PCR).

18. The method according to claim 15 wherein the results are reported within about fifty (50) hours of receiving the sample.

19. The method according to claim 18 wherein the results are reported within about thirty (30) hours of receiving the sample.

20. The method according to claim 15 which comprises pyrosequencing.