保存生物檢體 QC/QA (品管/品質保證) 趨勢：2015年
Stored Biospecimen QC/QA Trends 2015
|出版日期||內容資訊||英文 47 Pages
|保存生物檢體 QC/QA (品管/品質保證) 趨勢：2015年 Stored Biospecimen QC/QA Trends 2015|
|出版日期: 2015年10月16日||內容資訊: 英文 47 Pages||
本報告提供冷凍保存生物檢體對QC/QA (品管/品質保證) 的新必要條件相關資料，2015年9月實施的網站的基準調查結果為基礎，目前冷凍保存生物檢體的使用概況 、 QC/QA 檢驗相關見解，及新生物檢體 QC/QA 化驗套件的潛在興趣等分析。
This market report summarizes the results of HTStec's industry-wide global web-based benchmarking survey on the emerging requirements for the QC/QA (quality control/quality assurance) of frozen stored biospecimens carried out in September 2015.
The survey was initiated by HTStec on behalf of a client who is a technology developer that plans to launch a new assay kit for biospecimen QC/QA. Their technology allows for an aliquot to be removed for analysis without compromising the quality of the parent sample. Biomarkers are then profiled in the aliquot permitting assessment of pre-analytical events impacting quality and downstream analytical results.
The objective was to understand the current use of frozen stored biospecimens, views on QC/QA verification, and potential interest in a new biospecimen QC/QA assay kit.
The survey looked at the following aspects of stored biospecimen QC/QA, as practiced today (2015) and in a few cases as predicted for the future (2017): primary area where frozen biospecimens are utilized; grouping where involvement with stored biospecimens most readily fits; type of biospecimens and tissues investigated; % of the stored samples that are tissues versus biofluids; main applications or intended uses of stored biospecimens; % of stored biospecimens that have been used to date; % of stored biospecimens estimated to be fit-for-purpose; main obstacles that prevent respondents maximizing the use of their stored biospecimens; obstacles that limit downstream analysis of stored biospecimens; how biospecimens arrive to a biobank; whether stored biospecimens are subject to standardized SOPs prior to storage; training in standard sample submission protocols received; key drivers when biospecimens are initially deposited into a frozen storage facility; awareness of any QC/QA bioanalysis being undertaken on biospecimens prior to frozen storage; use of specific bioanalytical techniques prior to frozen storage; awareness of any biomarkers with predictable degradation profiles that could be used as surrogates of biospecimen integrity; preferred bioanalysis technique to establish QC/QA verification; perceived advantages of using a biospecimen QC/QA assay kit; use of an assay kit if it facilitated QC/QA; main reasons for not using an assay kit that facilitated biospecimen QC/QA; type of assay testing required to validate a QC/QA assay kit; whether respondents would immediately dispose of biospecimens considered degraded by an QC/QA kit; frequency stored biospecimens should be checked for QC/QA verification; how many samples might be tested for biospecimen QC/QA if an assay kit was reasonably priced; views on the pricing of a biospecimen QC/QA assay kit; preferred route to access a new methodology that facilitates biospecimen QC/QA; likelihood of purchasing any new lab instruments that enable biospecimen QC/QA in house; key challenges for a biostorage facility to implement a QC/QA process; budget to purchase consumables for biospecimen QC/QA; any unmet needs in the products that support biospecimen storage and their associated QC/QA; and respondents who are willing to be contacted to discuss their requirements further, want more information or who are you interested in performing an in-lab evaluations/providing feedback on a on new biospecimen QC/QA assay kit.
The main questionnaire consisted of 30 mainly multi-choice questions. In addition, there were 7 questions related solely to administration/survey demographics.
The survey collected 50 validated responses, of these 72% provided comprehensive input.
Survey responses were geographically split: 42% North America; 42% Europe; 8% Asia (excluding Japan & China); 4% Rest of World; and 4% China.
Survey respondents were drawn from persons who collect, store and utilize frozen biospecimens for research purposes or those planning future investigation.
Respondents represented 19 University/Research Institute/Not-for-Profit; 8 Biotech; 7 Hospital/Clinic/ Medical School; 5 Pharmaceuticals; 5 Contract Research Organisation; 3 Biobank; 2 Commercial Organisation (Vendor); and 2 Agrochemical.
Most survey respondents had a senior job role or position which was in descending order: 10 lab/research managers/coordinators; 8 senior scientists/research associates; 8 principal investigators; 6 research scientists; 6 directors; 5 department heads; 3 other job roles; 2 professors/assistant professors; 1 section/ group leader; and 1 vice-president.
Survey results were expressed as an average of all survey respondents. In addition, where appropriate the data was reanalyzed after sub-division into the following 5 survey groups: 1) Industry; 2) Academia; 3) Commercial; 4) End-Users; and 5) Management.
The majority of respondents were currently collecting, storing and utilizing frozen biospecimens.
The primary area where most respondents utilize frozen biospecimens was basic or academic research.
Respondents were made up of 64% sample management staff and 36% scientist/end-users.
The type of biospecimen most investigated for biological trends was plasma - EDTA added.
The type of tissue most investigated for biological trends was skin.
A median of 25% of stored samples used or managed by respondents were tissues versus biofluids.
The main application or intended use of stored biospecimens was biomarker research.
A median of 26-50% of biospecimens in respondent's frozen stores have been used to date.
A median of 51-75% of biospecimens in respondent's frozen stores are considered fit-for-purpose.
Enough sample available or misleading inventory info was rated as the main obstacle that limits downstream analysis of stored biospecimens.
Feedback on the obstacles that prevent maximizing use of stored biospecimens today was documented.
Collector delivers by hand by walking to the facility (i.e. on the same site) was the most used manner in which biospecimens arrive at a biobank.
Most samples are prepared on-site according to strict SOPs to minimize pre-analytical variables.
With respect to the training in standard sample submission most reported the protocols are written documents that are passed to the collectors undertaking the procedure.
Strict adherence to protocol was ranked the most critical driver when biospecimens were initially deposited into a frozen storage facility.
The majority of respondents had no awareness of any QC/QA analysis being undertaken on biospecimens.
Biospecimens were subject to QC/QA verification prior to frozen storage to the following median extent: pathology review of tissues - 1-25% verified; 260/280 for nucleic acid quality assessment - 1-25% verified; RIN score for RNA quality assessment - none (0%) verified; biomarker measurement - none (0%) verified; and DNA fingerprinting or genotyping - none (0%) verified.
The majority had no awareness of any biomarkers with predictable degradation profiles that could be used as surrogates of biospecimen integrity.
The preferred bioanalysis technique to establish QC/QA verification was N/A - we don't have one.
Provides end-users with measured confirmations of biospecimen quality was rated the most important perceived advantage of a biospecimen QC/QA kit.
The majority would use a biospecimen QC/QA verification kit if supporting validation was convincing.
Feedback on the type of assay testing required to validate a QC/QA assay kit was documented.
With respect to willingness to act on the results of a biospecimen QC/QA verification assay kit most selected - we would recommend disposal, but other parties may insist we keep degraded samples.
The preferred frequency of stored biospecimens QC/QA verification was once when first stored and again when distributed.
The likely use of a biospecimen QC/QA assay, if a reasonably priced kit was available, was to consider testing a median of 100-500 samples representing a median of 1-25% of all available stored samples.
The suggested pricing for a biospecimen QC/QA verification assay kit was: $3.00-$5.00 median reasonable price per single sample tested; and $6.00-$10.00 median maximum price per single sample tested.
The preferred way to access a new methodology that facilitates biospecimen QC/QA was to purchase specific assay kits tailored to existing lab instrumentation (e.g. plate reader, Luminex reader or MS).
The median likelihood of investing in any new instruments to enable biospecimen QC/QA in house was unlikely (1-25% chance).
None or insufficient budget for QC/QA testing was ranked the greatest concern (challenge) for a biostorage facility to implement a QC/QA process.
The median budget available today to purchase consumables for biospecimen QC/QA was $5K-$10K.
A bottom up model was developed to estimate the market potential of a stored biospecimen QC/QA kit using data derived from this survey. This valued the market at around $95million for the 3 year period post product launch, equivalent to a sales volume of >20 million tests.
28 respondents would like to receive more information on a new biospecimen QC/QA assay kit; 13 respondents were willing to be contacted to discuss their requirements further; and 11 respondents were interested in performing in-lab evaluations/providing feedback on a biospecimen QC/QA assay kit.
Some limited feedback on the unmet needs in the products that support biospecimen storage and their associated QC/QA were documented.
The full report provides the data, details of the breakdown of the responses to each question, its segmentation and estimates for the future (2017). It also highlights some interesting differences between the survey groups.
PLEASE NOTE: in this market report we are defining QC/QA as any bioanalytical technique or assay performed on biospecimens that leads to the verification of sample integrity and characterization of their state of biodegradation.