Example 1: Viral Studies
The example below shows how to represent HCV study data using the MB domain.
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| Row 1: | Shows the identification of Hepatitis C virus during SCREENING. This is a non-targeted assessment with the intent of the following query: “What microorganism(s) are there in the subject’s sample?" Therefore the MBTEST = Microbial Organism Identification, is used. | | Row 2: | Shows the further "sub-species specification" of the previously identified Hepatitis C Virus, and the result indicates that the HCV strain isolated from the subject is of "genotype 1". This test is still performed during the SCREENING visit. | | Row 3: | Shows the viral load measurement of Hepatitis C Virus Genotype 1 RNA during SCREENING. Note that "VIRAL LOAD" is represented by MBTSTDTL. | | Rows 4-5: | Show the detection of Hepatitis C Virus Genotype 1 and its viral load measurements at WEEK 2 visit. The result shows a reduction in HCV viral load after treatment, in comparison to the record in row 3. The targeted, microorganism-specific MBTEST of "Hepatitis C Virus Genotype 1" is used for the treatment cycle instead of "MBTEST=Microbial Organism Identification" because Hepatitis C Virus Genotype 1 infection had been confirmed during screening (Rows 1-3). Therefore, in this instance, the targeted, microorganism pre-coordinated MBTEST should be used. | | Rows 6-7: | Show the detection of Hepatitis C Virus Genotype 1 and its viral load measurements at WEEK 4 visit. The result shows continued reduction in HCV viral load after further treatment, in comparison to the record in row 5. | | Row 8: | Shows an absence of Hepatitis C Virus Genotype 1 in the subject after 6 weeks of treatment. |
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| Row | STUDYID | DOMAIN | USUBJID | MBSEQ | MBGRPID | MBTESTCD | MBTEST | MBTSTDTL | MBCAT | MBORRES | MBORRESU | MBSTRESC | MBSTRESN | MBSTRESU | MBSPEC | MBMETHOD | VISITNUM | VISIT | MBDTC |
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| 1 | ABC | MB | ABC-001 | 1 | 1 | MCORGIDN | Microbial Organism Identification | |
| MICROBIOLOGY | HEPATITIS C VIRUS |
| HEPATITIS C VIRUS | HEPATITIS C VIRUS | |
| BLOOD | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 0 | SCREENING | 2018-05-15 |
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| 3 | ABC | MB | ABC-001 | 3 | 1 | C_CODE | Hepatitis C Virus Genotype 1 RNA | VIRAL LOAD | MICROBIOLOGY | 7.8 | log 10 IU/mL | 7.8 | 7.8 | log 10 IU/mL | BLOOD | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 0 | SCREENING | 2018-05-15 |
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| 4 | ABC | MB | ABC-001 | 1 | 2 | C_CODE | Hepatitis C Virus Genotype 1 | DETECTION | MICROBIOLOGY | PRESENT | |
| PRESENT | PRESENT | |
| BLOOD | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 1 | WEEK 2 | 2018-06-01 |
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| 5 | ABC | MB | ABC-001 | 2 | 2 | C_CODE | Hepatitis C Virus Genotype 1 RNA | VIRAL LOAD | MICROBIOLOGY | 4.7 | log 10 IU/mL | 4.7 | 4.7 | log 10 IU/mL | BLOOD | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 1 | WEEK 2 | 2018-06-01 |
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| 6 | ABC | MB | ABC-001 | 1 | 3 | C_CODE | Hepatitis C Virus Genotype 1 | DETECTION | MICROBIOLOGY | PRESENT |
| PRESENT | PRESENT |
| BLOOD | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 2 | WEEK 4 | 2018-06-15 |
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| 7 | ABC | MB | ABC-001 | 2 | 3 | C_CODE | Hepatitis C Virus Genotype 1 RNA | VIRAL LOAD | MICROBIOLOGY | 1.8 | log 10 IU/mL | 1.8 | 1.8 | log 10 IU/mL | BLOOD | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 2 | WEEK 4 | 2018-06-15 |
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| 8 | ABC | MB | ABC-001 | 1 |
| C_CODE | Hepatitis C Virus Genotype 1 | DETECTION | MICROBIOLOGY | ABSENT |
| ABSENT | ABSENT |
| BLOOD | QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION | 3 | WEEK 6 | 2018-06-29 |
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For antibody and antigen testing, frequently both detection and quantification measurements are performed of the same TEST. The values "DETECTION" and "CONCENTRATION" therefore will populate the --TSTDTL variable. However, for clarity and consistency, even if only the detection of antibody test is performed and there is only one row of record, the value "DETECTION" should also populate the --TSTDTL variable. |
Example 2: Bacterial Studies
Non-specific microorganism identification test
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| Row 1: | During the screening process, subject ABC-008 who was suspected to have contracted tuberculosis had undergone a microbial identification test to verify whether Mycobacterium tuberculosis was present in the subject's lavage fluid sample. The lavage fluid sample was cultured on the MIDDLEBROOK 7H10 AGAR, which is a selective medium that supports the growth of M. tuberculosis and is represented by the MBMEDTYP NSV. However, other Mycobacterium species can also grow on this medium. Row 1 record shows the growth and thus presumptive identification of M. tuberculosis in the subject's sample.The MBTEST of "Microbial Organism Identification" is used here (row 1) in the screening process because while there was suspicion that the subject may have been infected with M. tuberculosis until agar testing was performed to confirm the existence of M. tuberculosis, this was a non-targeted assessment with the intent of the following query: “what microorganism(s) are there in the subject’s sample?" | | Rows 2-3: | Show the quantitative and ordinal colony count for Mycobacterium tuberculosis. From the same "colony count" test there are two results, one is quantitative (row 2) and one is ordinal (row 3), in order to distinguish the two records, the NSV MBRRSTYP is used to house "QUANTITATIVE" and "ORDINAL". | | Row 4: | Shows that after two weeks of treatment, the same subject was tested again for the presence of M. tuberculosis in his lavage fluid sample. The targeted, microorganism-specific MBTEST of "Mycobacterium Tuberculosis" is used for the treatment cycle instead of the "MBTEST = Microbial Organism Identification" because M. tuberculosis infection had been confirmed during screening (rows 1-4). Therefore in this instance, the targeted, microorganism pre-coordinated MBTEST should be used. | | Rows 5-6: | Show the quantitative and ordinal colony count of M. tuberculosis growing on the agar. Rows 6-7 show the reduction of colony numbers after treatment, in comparison to the records in rows 2-3. |
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| Row | STUDYID | DOMAIN | USUBJID | MBSEQ | MBGRPID | MBTESTCD | MBTEST | MBTSTDTL | MBORRES | MBORRESU | MBSTRESC | MBSTRESN | MBSTRESU | MBSPEC | MBMETHOD | VISITNUM | VISIT | MBDTC | |
| MBMEDTYP | MBRRSTYP |
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| 1 | ABC | MB | ABC-008 | 1 | 1 | MCORGIDN | Microbial Organism Identification | |
| Mycobacterium Tuberculosis | |
| Mycobacterium Tuberculosis | Mycobacterium Tuberculosis | |
| LAVAGE FLUID | MICROBIAL CULTURE, SOLID | 1 | SCRENING | 2017-08-21 | |
| MIDDLEBROOK 7H10 AGAR | |
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| ABC | MB | ABC-008 | 2 | 1 | MTB | Mycobacterium Tuberculosis | COLONY COUNT | 369 | CFU | 369 | 369 | CFU | LAVAGE FLUID | MICROBIAL CULTURE, SOLID | 1 | SCREENING | 2017-08-21 |
| MIDDLEBROOK 7H10 AGAR | QUANTITATIVE |
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| 3 | ABC | MB | ABC-008 | 3 | 1 | MTB | Mycobacterium Tuberculosis | COLONY COUNT | 3+ | |
| 3+ | | |
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| LAVAGE FLUID | MICROBIAL CULTURE, SOLID | 1 | SCREENING | 2017-08-21 | |
| MIDDLEBROOK 7H10 AGAR | ORDINAL |
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| 4 | ABC | MB | ABC-008 | 1 | 2 | MTB | Mycobacterium Tuberculosis | DETECTION | PRESENT | |
| PRESENT | PRESENT |
| LAVAGE FLUID | MICROBIAL CULTURE, SOLID | 2 | WEEK 2 | 2017-09-09 |
| MIDDLEBROOK 7H10 AGAR | |
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| 5 | ABC | MB | ABC-008 | 2 | 2 | MTB | Mycobacterium Tuberculosis | COLONY COUNT | 147 | CFU | 147 | 147 | CFU | LAVAGE FLUID | MICROBIAL CULTURE, SOLID | 2 | WEEK 2 | 2017-09-09 |
| MIDDLEBROOK 7H10 AGAR | QUANTITATIVE |
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| 6 | ABC | MB | ABC-008 | 3 | 2 | MTBAB | Mycobacterium Tuberculosis | COLONY COUNT | 1+ |
| 1+ | | |
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| LAVAGE FLUID | MICROBIAL CULTURE, SOLID | 2 | WEEK 2 | 2017-09-09 | |
| MIDDLEBROOK 7H10 AGAR | ORDINAL |
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| Variable | Label | Type | Role | Origin |
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| MBMEDTYP | Medium Type | text | Non-Standard Record Qualifier | eDT | | MBRRSTYP | Reported Result Scale Type | text | Non-Standard Record Qualifier | eDT |
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Please see here for a similar and more complete MB example dataset for CLOSTRIDIUM DIFFICILE: C. difficile Identification Example 1