IA产品应用问题处理办法汇总

1、IAIA产产品品应应用用问问题题处处理理办办法法汇汇总总最最新新更更新新时时间间：2011/9/272011/9/27内内容容说说明明：分分为为三三种种类类型型 类型 国内公开发的IPCA或者IPIN，来自QA，须分享给代理LSS和用户 类型 chask发的 support plan或者PCA，仅限内部使用，如之后国内公开发IPCA，请在追踪中更新说明 类型 最近总结的应用或者试剂问题，视具体情况做相应分享日日期期类类型型仪仪器器文文件件号号2011/9/28 类型 Access Family2011/9/2 类型 Access Family FYI2011C0462011-915 类型 Ac

2、cess FamilyIPCA-153782011/7/25 类型 Access FamilyIPCA-16241 2011/7/27 类型 Access Family2011/7/27 类型 Access FamilyPCA 14964-32011/7/11类型 Access FamilyTT4定标液2011/7/26 类型 Access FamilyTropI2011/7/7 类型 Access Family2011/5/26 类型 Access FamilyPCA-17154 2011/5/26 类型 Access FamilyTestosterone Calibrator PCA201

3、1/4/27 类型 Access FamilyProg假性低值的讨论2011/4/19 类型 Access FamilyPCA-16241 (ThermalRequirements) Mailing to USand Canada customers 2011/4/19 类型 Access FamilyIPCA-15982 Access Total T4Reagent Kit2011/3/11 类型 Access FamilyAccess ImmunoassaySystems SupportManagement PlanAPF Update 2011A2011/3/11 类型 Access F

4、amilyPCA-159822011/3/4 类型 Access Family效期里外不一致2011/2/1 类型 Access FamilyTT3 011887 013852 结果漂移2011/1/21 类型 Access FamilyPossible QC Shift up with TSH Reagent Lots 015993 and higher (Chaska lots) and 070164 and higher (Galway lots) 2011/1/14 类型 Access FamilyPossible QC and Patient ShiftDown with Free

5、T4 ReagentLot018460 & 0184612011/1/21 类型 Access FamilyPossible QC shift down withProgesterone reagent lot0217262011/2/24 类型 Access FamilyIPCA-15925 AccessThyroglobulin Antibody II (PartNumber A32898)2011/2/12 类型 Access FamilyIIPIN-16093 Access HybritechPSA assay (PN 37200)2011/1/13 类型 Access Fam

6、ily#FYI2010C0662010/12/14 类型 Access FamilyDS-2010-12-0082011/1/7 类型 Access FamilyIPCA-14964-2 Access Free T4Calibrator Stability2010/12/10 类型 Access FamilyIPCA-15144 Access Total hCG Assay问问题题影影响响A QC shift down may be observedwith Total T4 reagent Lots 116012,112779, 114884 and 119099.A QC shift do

7、wn may be observed withTotal T4 reagent Lots 116012, 112779,114884 and 119099.Estradiol Antibody Replacement -Reagent Lots 112900.BeckmanCoulter is replacing the polyclonalantibody currently used in theAccess Estradiol reagent (P/N33540) This decrease in estriol cross-reactivity has resulted in a sh

8、ift incommercial quality controlmaterial,Patient samples that areless than 1000 pg/mL (3671pmol/L) may demonstrate anapproximate 10% increase inconcentration. 皮质醇定标液916525, 919443,010296, 012923, 015957, 017560,上述批号的皮质醇定标液包装盒上的中文标签内容误写为“试剂”或“试剂盒”，正确的描述应该是“定标液”（英文名称正确）.注: 定标液瓶子上的标注是正确的. 不会对临床患者结果产生任何

9、影响.实验室温度的变化可能会影响到Access化学发光系统上部分样本的某些试验项目性能。不当的结果可能会导致不当的诊断和治疗QC shift down with Total T4 reagentlots 116012 and 112779Total T4 calibrator lots 019818,021654 and 024072 showingdecreased stabilityQC降低，病人结果也低河南、广州、福州出现TT4 019818定标液导致质控和病人结果偏低Possible QC shift down with AccuTnI(p/n A78803) reagent lot

10、113961QC会有最多13%的降低当转到此批号时a QC shift down with Cortisol reagentlot 110904 and 113861病人结果尤其在低值会有14%的下降Access Ostase reagent lot 021281does not meet its expiration dateclaim due to identified reagent packinstability.Patient sample results may be falselyelevated by up to 10% at seven andeight months pri

11、or to expiration(Expiration Date: December 31, 2011). 发现睾酮的稀释回收率达不到现在说明书上的要求，最近一份实验数据，34份男性血清从4-10ng/ml，1/2的稀释回收率从95%-137%,平均达到110%对病人结果并无影响北区和东区相继出现DXI800、Access2用户遇到，样本第一次检测为低值与临床不符，复查后变为高值。用户投诉Prog重复性不好，不稳定，但此现象只有一个月才出现一两例1. We are revising the roomtemperature operating range by 2Cfor all platfor

12、ms.- Current Specification 18C to 32C(64.4F to 89.6F)- New Specification 18C to 30C(64.4F to 86.0F)2. In addition, Access platforms andDxI platforms will each have uniquerequirements for specific assays.- Most assays may run unrestrictedin a temperature range of 18-30C(64.4-86.0F) unless specified i

13、n theletter. Exceptions include: - AccuTnI must now operateat a range of 21-28C (69.8-82.4F) - Some assays requirerecalibration if the room temperaturevaries more than 4C (7.2F) fromthe temperature at which assaycalibration was established. See theindividual letters for a list of theseassays.实验室环境温度

14、变化过大对所有项目都有影响，要求温度变化在4度之内IAIA产产品品应应用用问问题题处处理理办办法法汇汇总总 类型 chask发的 support plan或者PCA，仅限内部使用，如之后国内公开发IPCA，请在追踪中更新说明在使用化学发光系统进行总甲状腺素（Total T4）测定的时候，来自于孕妇样本的总甲状腺素（Total T4）浓度可能会有假性降低（20%）影响：假性降低的结果实际上是一个高的结果（可能超出了正常的参考范围），可能会掩饰甲状腺功能亢进。对怀孕相关的甲状腺功能亢进疾病的诊断或治疗不当可能会对胎儿/新生儿产生一定的长期损害 APFs available to order 31-

15、Jan-11.Documents provided electronically. 主要增加了FRT3 - 284 (PCAResolution) * HIVco - 262。 以解决如下FRT3的稳定性问题：PCA-C-E-1029 notified our customersthat the open reagent pack stability fortheAccess Free T3 assay had decreasedfrom 28 to 7 days. You can continueusing yourcurrent Access Free T3 (APF 212)reagen

16、t packs, provided you manuallymonitor the7 day open pack expiration. Thisinformation is also presented on astuffer placedinside of the Free T3 reagent pack kits.Beckman Coulter is preparing totransition ourcustomers to a new Free T3 APF thatenables your system to automaticallymonitorthe 7 day open p

17、ack expiration.You will receive a Free T3communication package in the comingmonths. Thispackage will include instructions forimplementing the new APF in yourlaboratory.There are important software updates inthis APF upgrade that prepare yoursystemfor the transition.During pregnancy, total T4 levelst

18、ypically increase greater than 30%.The Access Total T4 reagent doesnot respond in pregnancy asexpected. Only 9% increase vs. non-pregnant subjects. Due to the lack inresponse, customers may seeerroneously low total T4 results forpregnant subjects up to -20%.Only pregnant females affected. Alllot num

19、bers of Access Total T4 arepresumed to be affected.This issue was discovered throughcustomer feedback and through ourinternal evaluation process.主要影响孕妇的T4检测结果TT4 014073 外面贴的标签效期为11-6-30，里面试剂效期为11-8-30，而且质控和病人结果都偏高，在其他试剂定标液如皮质醇等都有此现象用户投诉不一致Through internal testing andcustomer feedback we havedetermin

20、ed that customersmay see QC variability with reagentlots 011887 and 013852:o QC L1 ( 0.78 ng/mL) may see anoverall trend high of up to 43% or anoverall trend low of up to -37%.o QC L3 ( 3.18 ng/mL) may see anoverall trend high of up to 31% or anoverall trend low of up to -21%.o Patient samples (at 1

21、.85 ng/mL)may see an overall trend high of up to23% or an overall trend low of up to -19%. The amount of variability maydepend on:o Where a calibration takes placewithin a pack.o Previous reagent or calibrator lotnumbers in use.o Instrument to instrument variability.o Calibration to calibration vari

22、ability.o See Chart 1 in the data section forsummary of internal data. These lots met all internalmanufacturing specifications forrelease.lots 011887 and 013852:批间差大，质控和病人都有偏差Through internal testing we havedetermined that customers may seea shift up inBio-Rad QC of approximately 10-15%when transiti

23、oning to TSH Reagentlotnumbers 015993 and above forproduct manufactured in Chaska, and070164 andabove for product manufactured inGalway.o The shift is seen across the entirerange, affecting all levels of QC.o The amount of shift may vary basedon previous reagent or calibrator lotnumbers in use, inst

24、rument toinstrument variability, and calibrationtocalibration variability.o Data is not available for alternateQC vendors. This support plan will beupdated when MAS QC data isavailable.o Internal testing indicates patientsamples are not affected and theexpectedvalues section of the insert has beenve

25、rified. These reagent lots met all internalspecifications for release.This shift is within the lot to lotvariability of the assay批间差，在允许范围之内Through internal testing and customer feedback we have determined that customersmay see a shift down when transitioning to reagent lot numbers 018460 and 018461

26、.o QC may see a shift down of approximately 10%o Patients may see a shift down of approximately 10%.o The amount of shift may vary basedon previous reagent or calibrator lotnumbers in use, instrument to instrument variability, and calibration tocalibration variability. The shift is seen across the e

27、ntiremeasuring range but is mainly seenon the lowend.o See Chart 1 and Tables 1-2 in the data section for summary of internal datafor all QC levels tested and how the internal results compared to the controlinsert mean and peer group data. This lot met all internal specifications for releaselot numb

28、ers 018460 and 018461质控和样本都会降低10%质控降低5-15%,病人降低2-7%质控降低5-15%,病人降低2-7%甲状腺球蛋白抗体A32898 012741014751 016551 016838效期分别为2011年5月31号 2011年7月31号 2011年8月31号 2011年9月30号上述批号的甲状腺球蛋白抗体II(TgAb)试剂可能存在盒间差。可能会产生错误的患者和质控结果。该TgAbII试剂批号可能产生： 患者和质控的TgAb结果可能会假性偏高 受到影响的试剂盒用于定标，而测定患者和质控结果来自于没有受到影响的试剂盒。可能会产生假性偏低结果。由于同批号的试剂盒

29、之间的盒间差，质控和患者结果可能会出现变异，质控结果可能不能用于监测该问题。 假性增高的结果可能会影响或延误诊断治疗，包括不必要的其他诊断测试。 假性降低的结果可能会影响或延误诊断治疗，包括甲状腺癌的复发监测。关注患者健康安全是我们一贯以来的宗旨，我司对我们所有产品的相关性能进行了评估。其中有一位用户报告了使用当前批号的PSA结果与之前批号和其他方法学相比时，有五例患者结果出现可重现性增高的情况。来自于用户的调查表明这些结果很有可能是由于异嗜性抗体的反应而引起的。这些具有代表性的结果为0.1 0.6ng/mL，这也是分析范围的低限。虽然这种由于异嗜性抗体所造成潜在假阳性结果的可能性在产品标签中

30、有说明，并且在前列腺癌术后患者中阳性结果的发生率被证实是很低的（约只有0.4%的患者），贝克曼库尔特还是要提醒您，由于前列腺癌术后患者可能存在假阳性PSA结果，需要在疾病复发的判断上特别注意#FYI2010C066提示各位，从批号017458开始， 之后所有的FT4定标液将在低于等于-20度环境下冷冻， 在室温下溶解最多2小时之后需再次冷冻贝克曼库尔特美国总部经全球调查发现，目前有多家公司提供商业化的肌钙蛋白I 质控。 因此， 我们将从2011年3月1日起停止供应现有的货号为33349的 AccuTnI QC。 您可联系以下的商业配套质控生产商购买相应肌钙蛋白I的质控。Bio-Rad Labo

31、ratories, www.bio-Medical Analysis Systems, Inc.,www.mas-More Diagnostics, Inc.,公司了解到批号为014769的Free T4定标液可能达不到标识上所示的稳定期。对于质控和患者样本可能会产生假性降低的结果（超过2SD），假性降低的患者结果会诊断和/或治疗造成错误判断公司了解到化学发光系统的TotalhCG结果可能会发生偶发性的假性增高。此类假性增高的结果经常由分析前因素导致并在测定范围低值区域的时候表现明显。处处理理追追踪踪 今后的皮质醇定标液将更新为正确的中文标签 贝克曼库尔特公司要求将所有的化学发光系统的房间工作

32、温度调整为18C 到 30C 此外，在所有Access化学发光系统上，下列项目需要进一步限定房间工作温度o AccuTnI (货号 A78803)工作时的房间温度为21C 到 28Co Cortisol(货号33600) 和TriageBNP (货号98200) 与定标时相比，如果房间温度变化超出了4C，需要重新定标 其他所有在ACCESS化学发光系统上运行的的项目在18C 到30C范围内工作时无限制，除非在使用说明书上另有说明。 确保在系统工作期间，实验室有一套监控房间温度的流程。效期只有2个月，019818到2011-1-17，021654到2011-2-28，024072到2011-5-6美美国国已已发发PCAPCA病人结果的影响数据随后发出会修正睾酮的说明书1、质控正常 2、 分析前：一家用户已将试管换为无添加剂的，严格控制凝固时间和离心，仍未解决3、试剂：无固定批号 4仪器：所有系统检测和测试都正常请请大大家家反反馈馈相相应应信信息息，还还是是怀怀疑疑仪仪器器的的问