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利用尿液药物检测的免疫分析法与液相色谱串联质谱法(LC/MS/MS)对慢性疼痛患者进行苯二氮䓬类药物检测的准确性进行比较评估。

Comparative evaluation of the accuracy of benzodiazepine testing in chronic pain patients utilizing immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing.

机构信息

Pain Management Center of Paducah, Paducah, KY 42003, USA.

出版信息

Pain Physician. 2011 May-Jun;14(3):259-70.

PMID:21587329
Abstract

BACKGROUND

Eradicating or appreciably limiting controlled prescription drug abuse, such as opioids and benzodiazepines, continues to be a challenge for clinicians, while providing needed, proper treatment. Detection of misuse and abuse is facilitated with urine drug testing (UDT). However, there are those who dispute UDT's diagnostic accuracy when done in the office (immunoassay) and claim that laboratory confirmation using liquid chromatography tandem mass spectrometry (LC/MS/MS) is required in each and every examination.

STUDY DESIGN

A diagnostic accuracy study of UDT.

STUDY SETTING

The study was conducted in a tertiary referral center and interventional pain management practice in the United States.

OBJECTIVE

Comparing UDT results of in-office immunoassay testing (the index test) with LC/MS/MS (the reference test).

METHODS

A total of 1,000 consecutive patients were recruited to be participants. Along with demographic information, a urine sample was obtained from them. A nurse conducted the immunoassay testing at the interventional pain management practice location; a laboratory conducted the LC/MS/MS. All index test results were compared with the reference test results. The index test's efficiency (agreement) was calculated as were calculations for sensitivity, specificity, false-positive, and false-negative rates.

RESULTS

Approximately 36% of the specimens required confirmation. The index test's efficiency for prescribed benzodiazepines was 78.4%. Reference testing improved accuracy to 83.2%, a 19.6% increase, and 8.9% of participants were found to be taking non-prescribed benzodiazepines. The index test's false-positive rate for benzodiazepines use was 10.5% in patients receiving benzodiazepines.

LIMITATIONS

This study was limited by its single-site location, its use of a single type of point of care (POC) kit, and reference testing being conducted by a single laboratory, as well as technical sponsorship.

CONCLUSION

Clinicians should feel comfortable conducting in-office UDT immunoassay testing. The present study shows that it is reliable, expedient, and fiscally sound for all involved. In-office immunoassay testing compares favorably with laboratory testing for benzodiazepines, offering both high specificity and agreement. However, clinicians should be vigilant and wary when interpreting results, weighing all factors involved in their decision.

摘要

背景

消除或显著限制受控处方药物滥用,如阿片类药物和苯二氮䓬类药物,对于临床医生来说仍然是一个挑战,同时需要提供必要的适当治疗。尿液药物检测(UDT)有助于发现误用和滥用。然而,有些人质疑在办公室进行 UDT(免疫测定)的诊断准确性,并声称每次检查都需要使用液相色谱串联质谱(LC/MS/MS)进行实验室确认。

研究设计

UDT 的诊断准确性研究。

研究设置

该研究在美国的一个三级转诊中心和介入性疼痛管理实践中进行。

目的

比较办公室免疫测定测试(指标测试)和 LC/MS/MS(参考测试)的 UDT 结果。

方法

共招募了 1000 名连续患者作为参与者。除了人口统计学信息外,还从他们那里获得了尿液样本。护士在介入性疼痛管理实践地点进行免疫测定测试;实验室进行 LC/MS/MS。将所有指标测试结果与参考测试结果进行比较。计算了指标测试的效率(一致性)以及灵敏度、特异性、假阳性和假阴性率的计算。

结果

大约 36%的标本需要确认。苯二氮䓬类药物的指标测试效率为 78.4%。参考测试将准确性提高到 83.2%,提高了 19.6%,发现 8.9%的参与者正在服用非处方苯二氮䓬类药物。接受苯二氮䓬类药物治疗的患者中,苯二氮䓬类药物使用的指标测试假阳性率为 10.5%。

局限性

本研究受到其单站点位置、使用单一类型的即时检测(POC)试剂盒以及参考测试由单一实验室进行以及技术赞助的限制。

结论

临床医生应该放心进行办公室 UDT 免疫测定测试。本研究表明,对于所有相关人员来说,它是可靠、便捷且经济合理的。办公室免疫测定测试与苯二氮䓬类药物的实验室测试相比具有优势,具有高特异性和一致性。然而,临床医生在解释结果时应保持警惕和谨慎,权衡其决策中涉及的所有因素。

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