Page History

Introduction

Persistent infection with Human Papillomavirus (HPV) is the main cause of cervical cancer and is a precursor to cervical intraepithelial neoplasia (CIN). HPV is a nonenveloped, double-stranded DNA virus, and more than 150 different types of HPV have been identified. A subset of these types is considered high-risk ( for the development of cervical cancer and its precursor lesions, and is routinely screened clinically in the context of cervical cancer prevention. The HPV test data modeled in this example represent a class of commercially available assays that are able to screen and detect multiple types of high-risk HPV from a subject specimen in a single analysis. https://www.uspharmacist.com/article/human-papillomavirus-cervical-cancer-and-prevention

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New Variable Proposal

Impact on Controlled Terminology

1. Existing multi-target MBTESTs: NO deprecation.
2. New multi-target MBTEST requests: the MB team will continue to create new, pre-coordinated, multi-target tests when the team can fit all the targets into the MBTEST and the TEST is **meaningful**.
   1. CT rules on a "meaningful" pre-coordinated MBTEST:
      1. The MBTEST should clearly describe the microorganism(s) being assessed, either using full taxonomic name or scientifically accepted acronym/abbreviation.
      2. The MBTEST should clearly describe the antigenic target(s) using scientifically accepted full name or acronym/abbreviation.
      3. If excessive abbreviation/truncation is required to fit all targets into the MBTEST which makes the test less human-readable (and in turn a less useful SDTM mapping asset), or users are required to rely on the spelled-out CDISC synonyms to understand the intent of the value in MBTEST, a pre-coordinated MBTEST should be avoided.
      4. It is the MB team's responsibility to determine meaningfulness for a pre-coordinated MBTEST and whether or not to develop controlled tests, on a case by case basis. If the MB team is unable to develop a meaningful MBTEST, the team will provide mapping recommendations in the denied request message.
3. The post-coordination, additional variable approach will be recommended when a pre-coordinated and meaningful MBTEST is not possible, as in the case of the HPV multi-target test.
   1. CT Rules on post-coordinated MBTEST:
      
      1. The MBTEST should describe, on a high-level, and to the team's best ability, the overall type or taxonomic grouping commonality (if available) of the microorganism(s) being detected. Examples: MBTEST = HPV Type DNA (when the asseemsnet detects HPV Type 22+45+18+16+58+66 DNA); MBTEST = Coronavirus RNA (when the assessment detects SARS-related Coronavirus RNA+MERS RNA); MBTEST = Campylobacter DNA (when the test detects Campylobacter aviculae+Campylobacter bilis+Campylobacter corcagiensis+Campylobacter gracilis).
      2. For MBTEST, the abbreviation "MLTTRG (short for Multi-Target)" should be added to the end of the MBTEST, e.g. Coronavirus RNA, MLTTRG. For MBTESTCD, the letter "M" (which is equivalent to MLTTRG) is used at the end of the TESTCD, e.g. HRHPDNM.
      3. When "MLTTRG" appears in the MBTEST, this indicates a test that targets multiple microorganism(s) and/or microbial antigen(s) which have been post-coordinated. Users should map the specific multiple targets to --MOTRG and/or --MAGTRG.
      4. For unrelated multiple targeted microorganisms or when taxonomic commonality is difficult to determine, a generic MBTEST such as Bacteria, MLTTRG; Virus, MLTTRG, may be created. Example: MBTEST = Bacteria, MLTTRG (when test detects Shigella spp+Campylobacter spp+Clostridium difficile+EIEC+ETEC).

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