Non-laboratory Personnel Research Articles

Clinical Need for Point-of-Care Testing for Diabetes in Clinical and Laboratory Improvement Amendments–Waived Settings

Point-of-care testing (POCT) has been used in multiple care settings for acute disease and, to a lesser extent, chronic disease testing. All POCT is regulated under the Clinical and Laboratory Improvement Amendments of 1988 (CLIA). CLIA-waived POCT requires no proficiency testing and can be carried out by nonlaboratory personnel. This review describes the benefits and limitations of POCT for cardiometabolic diseases and related conditions. It also explores the current U.S. regulatory environment for CLIA-waived POCT, highlighting the need for increased access.

Point of Care Testing: A Discipline that is Growing

Traditionally, diagnostic testing is carried out on patients’ samples ( blood, urine etc) in pathology laboratories by skilled scientists. Transport to the laboratory and subsequent processing (often in batches) can sometimes lead to long turnaround times for the patient and the clinician. Point of Care (POC) or ‘near patient’ testing refers to testing and reporting at the site of patient care and is usually undertaken by non-laboratory personnel. POC technology has a number of attractions as there is a fast turnaround time and this can have enormous benefits for the patient and the clinician.

Point of care testing in the perioperative period.

The range of point of care tests continues to increase. Point of care testing is frequently undertaken by nonlaboratory personnel and clinicians should understand the tests available and their applicability in clinical practice.

Diagnostic performance of GenBody COVID-19 rapid antigen test for laboratory and non-laboratory medical professionals in real practice: A retrospective study.

Point-of-care tests for coronavirus disease 2019 (COVID-19) antigen detection have been widely used for rapid diagnosis in various settings. However, research on the diagnostic performance of the COVID-19 antigen test performed by non-laboratory personnel is limited. In this study, we aimed to elucidate the diagnostic performance of GenBody COVID-19 rapid antigen between laboratory professionals and non-laboratory staff. We retrospectively analyzed the data of patients who underwent both GenBody COVID-19 rapid antigen testing and reverse transcription polymerase chain reaction (RT-PCR) between November 01, 2021, and June 30, 2022. The diagnostic performance of the antigen test was compared between laboratory and non-laboratory operators, using RT-PCR as the gold standard. Sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, positive predictive value, negative predictive value, and accuracy were calculated and sensitivity analysis was performed based on the PCR cycle threshold (Ct) value. Of the 11,963 patients, 1273 (10.6%) tested positive using real-time RT-PCR. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio, positive predictive value, negative predictive value, and accuracy of the GenBody COVID-19 rapid antigen test with 95% confidence interval were 79.92% (77.26%-82.39%), 99.23% (98.73%-99.57%), 103.25 (62.31-171.11), 0.2 (0.18-0.23), 510.18 (299.81-868.18), 98.11% (96.91%-98.85%), 90.75% (89.64%-91.75%) and 92.76% (91.76%-93.67%), respectively, for non-laboratory staff and 79.80% (74.78%-84.22%), 99.99% (99.94%-100.00%), 6983.92 (983.03-49617.00), 0.2 (0.16-0.25), 34566.45 (4770.30-250474.46) 99.58% (97.09%-99.94%), 99.32% (99.15%-99.46%), and 99.33% (99.13%-99.48%), respectively, for laboratory staff. Notably, when the PCR Ct value exceeded 25, the sensitivity of both the groups decreased to < 40%. The diagnostic performance of GenBody COVID-19 rapid antigen performed by non-laboratory staff was comparable to that of laboratory professionals. However, it should be noted that the sensitivity of the antigen tests decreased when the PCR Ct value exceeded 25. Overall, the GenBody COVID-19 antigen test is a viable option for non-laboratory staff during an epidemic.

Economics of point-of-care infant HIV tests

Economics of point-of-care infant HIV tests

Lessons From the Field: Rapid Antigen Testing Is Efficient and Practical for Mitigation of Coronavirus Disease 2019 Outbreaks in Long-Term Care Facilities.

Mitigation of coronavirus disease 2019 (COVID-19) outbreaks in long-term care facilities (LTCFs) is facilitated by rapid identification and isolation of infectious individuals to interrupt viral transmission. Immunochromatographic (IC) tests, or rapid antigen tests, have high sensitivity and specificity during the contagious period for COVID-19. Mathematical modeling predicts frequent IC surveillance will be more efficient than polymerase chain reaction (PCR)-based strategies, especially during community surges when reporting of PCR results can be delayed. However, there are few published field studies evaluating IC testing strategies in this long-term care setting. In fall and winter of 2020, the Marin Health and Human Services Department implemented thrice-weekly IC mass testing by nonlaboratory workers in outbreaks that occurred in 2 LTCFs, in addition to then-standard semiweekly PCR testing. The IC test performance was characterized using same-day PCR specimens as reference standard. Cumulative incidence and duration of transmission for the 2 IC intervention facility outbreaks were compared with 6 reference LTCFs that used weekly to semiweekly PCR alone during an outbreak response. Of 123 same-day test pairs, IC test sensitivity and specificity were 75% (95% confidence interval [CI], 48%-93%) and 100% (95% CI, 97%-100%), respectively. The median duration of outbreak transmission was 19.5 days in the 2 intervention sites and 28 days in the reference facilities (P = .40). Cumulative incidence for the outbreaks among LTCF residents was 41% in the intervention facilities versus 52% in the reference facilities (P = .04, Fisher 2-sided exact). Thrice-weekly mass IC testing as used by nonlaboratory personnel can be highly practical and effective for COVID-19 outbreak mitigation in the LTCF setting.

The impact of laboratory staff training workshops on coagulation specimen rejection rates.

BackgroundPre-analytical variables can have a significant adverse impact on the quality and credibility of coagulation test results. Therefore, correct and consistent identification of pre-analytical variables that compromise coagulation specimen quality is of paramount importance. Lack of standardization and heterogeneity among laboratory staff when assessing coagulation specimens can lead to inconsistent identification of these variables. Failure to recognize such pre-analytical variables results in the analysis of poor quality specimens and the authorization of spurious test results.ObjectivesTo determine the impact of a laboratory staff training workshop on coagulation specimen rejection rates and to ascertain the level of knowledge of laboratory personnel concerning coagulation specimen rejection criteria before and after the workshop.MethodsA retrospective three-month audit was performed with rejection data of incorrect blood to additive ratio, clotted, aged and haemolysed specimens collected. Training workshops and evaluation sessions were subsequently presented. A revised standard operating procedure delineating coagulation specimen rejection criteria was implemented and a repeat three-month audit was conducted.ResultsIn total, 13 162 coagulation specimens were received during the initial audit with 1 104 specimens (8.39%) rejected. Following the workshops, the rejection rate increased by 3.49% to 11.88% with 12 743 coagulation specimens received and 1 514 specimens rejected. Evaluation sessions performed before and after the workshops revealed that 95.2% of attendees attained improved knowledge.ConclusionThis study demonstrated the pivotal importance of regular laboratory staff training. The increase in specimen rejection following the workshops signifies their success in educating laboratory personnel regarding the correct identification of pre-analytical variables. Since most pre-analytical variables occur outside the laboratory, educational workshops need to be extended to non-laboratory personnel responsible for specimen collection and transport.

Point of care CYP2C19 genotyping after percutaneous coronary intervention.

Loss-of-function CYP2C19 variants are associated with increased cumulative ischemic outcomes warranting CYP2C19 genotyping prior to clopidogrel administration. TAILOR-PCI was an international, multicenter (40 sites), prospective, randomized trial comparing rapid point of care (POC) genotype-guided vs. conventional anti-platelet therapy. The performance of buccal-based rapid CYP2C19 genotyping performed by non-laboratory-trained staff in TAILOR-PCI was assessed. Pre-trial training and evaluation involved rapid genotyping of 373 oral samples, with 99.5% (371/373) concordance with Sanger sequencing. During TAILOR-PCI, 5302 patients undergoing PCI were randomized to POC rapid CYP2C19 *2, *3, and *17 genotyping versus no genotyping. At 12 months post-PCI, TaqMan genotyping determined 99.1% (2,364/2,385) concordance with the POC results, with 90.7-98.8% sensitivity and 99.2-99.6% specificity. In conclusion, non-laboratory personnel can be successfully trained for on-site instrument operation and POC rapid genotyping with analytical accuracy and precision across multiple international centers, thereby supporting POC genotyping in patient-care settings, such as the cardiac catheterization laboratory.Clinical Trial Registration: https://www.clinicalTrials.gov (Identifier: NCT01742117).

Pre-analytical rejection rates of clinical samples based on patients’ health status

Background and objective: The pre-analytical rejection rate is the proportion of samples rejected at the stage that includes the initial procedures of the testing process performed outside the laboratory walls by healthcare professionals. This study aimed to evaluate the pre-analytical rejection rate by considering the health status of the patients and the sample types and to examine the measures that can be taken against it. Methods: The data of the samples that came to the laboratory for analysis for one year were included. These data were categorized according to sample types in complete blood count, biochemistry, hormones, urine, blood gases, coagulation, erythrocyte sedimentation rate (ESR), glycosylated hemoglobin (HbA1c). It was also categorized by emergency, outpatient, inpatient, and critically ill status. Considering the health status of the patients, the pre-analytical rejection rates determined in these sample types were compared. Results: Complete blood count (0.40%) in emergency patients, HbA1c (0.78%) in outpatients, biochemistry (0.62%) in inpatients, hormones (0.29%), urine (6.19%) blood gases (1.03%), coagulation (1.26%), ESR (3.23%) in critical patients, sample types had the highest pre-analytical rejection rate. Conclusions: The source of causes that affect pre-analytical rejection rates, such as hemolyzed sample, clotted sample, or insufficient sample, may be due to the patient's bed rest, critical or emergency. An underlying disease, treatment, or frequent phlebotomy may also be a factor. The source of the causes that affect the pre-analytical rejection rates, such as incorrect request, incorrect registration, and incorrect tube, can usually be attributed to non-laboratory healthcare personnel.

Performance of antigen testing for diagnosis of COVID-19: a direct comparison of a lateral flow device to nucleic acid amplification based tests

ObjectivesThe gold standard for diagnosing an infection with SARS-CoV-2 is detection of viral RNA by nucleic acid amplification techniques. Test capacities, however, are limited. Therefore, numerous easy-to-use rapid antigen tests based on lateral flow technology have been developed. Manufacturer-reported performance data seem convincing, but real-world data are missing.MethodsWe retrospectively analysed all prospectively collected antigen tests results performed between 23.06.2020 and 26.11.2020, generated by non-laboratory personnel at the point-of-care from oro- or nasopharyngeal swab samples at the University Hospital Augsburg and compared them to concomitantly (within 24 h.) generated results from molecular tests.ResultsFor a total of 3630 antigen tests, 3110 NAAT results were available. Overall, sensitivity, specificity, NPV and PPV of antigen testing were 59.4%, 99.0%, 98.7% and 64.8%, respectively. Sensitivity and PPV were lower in asymptomatic patients (47.6% and 44.4%, respectively) and only slightly higher in patients with clinical symptoms (66.7% and 85.0%, respectively). Some samples with very low Ct-values (minimum Ct 13) were not detected by antigen testing. 31 false positive results occurred. ROC curve analysis showed that reducing the COI cut-off from 1, as suggested by the manufacturer, to 0.9 is optimal, albeit with an AUC of only 0.66.ConclusionIn real life, performance of lateral-flow-based antigen tests are well below the manufacturer's specifications, irrespective of patient’s symptoms. Their use for detection of individual patients infected with SARS-CoV2 should be discouraged. This does not preclude their usefulness in large-scale screening programs to reduce transmission events on a population-wide scale.

Unique Approach to Quality Assurance in Viscoelastic Testing.

The Quantra QPlus System is a novel viscoelastic testing (VET) device designed for the management of coagulation function in critical care settings. The system is indicated and approved for use at the point-of-care and designed for use by nonlaboratory personnel. We describe the comprehensive set of internal QC checks implemented in the Quantra and demonstrate the system's unique capabilities made possible by its ultrasound core technology. Single- and multisite precision testing were performed following Clinical Laboratory Standards Institute guidelines and included multiple days of testing, multiple instruments, multiple lots of cartridges and controls, and multiple operators. Percent CVs for total imprecision were 3.6% to 8.0% for all measured parameters. CVs for replicate imprecision ("repeatability") were 2.7% to 7.7% for all measured parameters. Replicate imprecision was the largest component of variability for most parameters. The Quantra QPlus System is a new-generation cartridge-based VET device that can operate with reduced oversight from the central laboratory while easily integrating into the Individualized Quality Control Plan framework.

Analytical performances of the BD Veritor™ System for the detection of respiratory syncytial virus and influenzaviruses A and B when used at bedside in the pediatric emergency department

This study aims to evaluate the analytical performance of the BD Veritor™ rapid diagnostic assays (RDTs) for respiratory syncytial virus (RSV) and influenzaviruses when performed 24/7 at bedside by nurses in the pediatric emergency department (PED). The study was performed between 14/10/2015 and 19/03/2016 on nasopharyngeal aspirates (NPAs) collected from children consulting at the PED of the University Hospital of Saint-Etienne for bronchiolitis (RSV detection) or flu-like syndrome (influenzaviruses A/B detection). NPAs were tested 24/7 at the PED with the RDT and then sent to the Infectious Agents Department for routine analyses, first by immunofluorescence assay (IFA), then by nucleic acid amplification test (NAAT) considered as the gold standard in case of discrepancy between RDT and IFA results. For RSV detection, 205 NPAs was analyzed; the overall concordance between RDT and routine assays was of 97.6% (200/205). The sensitivity (Se), specificity (Sp), negative predictive value (NPV) and positive predictive value (PPV) were of 97.6% (160/164), 97.6% (40/41), 90.9% (40/44) and 99.4% (160/161), respectively. A total of 419 NPA was tested for influenzaviruses. For influenzavirus A, the overall concordance was of 98.8% (414/419); Se, Sp, NPV and PPV were of 100% (41/41), 98.7% (373/378), 100% (373/373) and 89.1% (41/46), respectively. For influenzavirus B, the overall concordance was of 97.9% (410/419); Se, Sp, NPV and PPV were of 96.6% (172/178), 98.8% (238/241), 97.5% (238/244) and 98.3% (172/175), respectively. Due to their excellent performances and their easy handle by non-laboratory personnel, these RDTs can be warmly recommended as point of care assays at the PED.

External quality assessment for HIV rapid tests: challenges and opportunities in Haiti

HIV rapid diagnostic tests (RDTs) are instrumental in scaling-up HIV testing services (HTS) in low-income and middle-income countries (LMICs). HIV misdiagnosis is a growing concern in the era of expanded...

Internal validation of the RapidHIT® ID system

Traditionally, forensic DNA analysis has required highly skilled forensic geneticists in a dedicated laboratory to generate short tandem repeat (STR) profiles. STR profiles are routinely used either to associate or exclude potential donors of forensic biological evidence. The typing of forensic reference samples has become more demanding, especially with the requirement in some jurisdictions to DNA profile arrestees. The Rapid DNA (RDNA) platform, the RapidHIT® ID (IntegenX®, Pleasanton, CA), is a fully automated system capable of processing reference samples in approximately 90min with minimal human intervention. Thus, the RapidHIT ID instrument can be deployed to non-laboratory environments (e.g., booking stations) and run by trained atypical personnel such as law enforcement. In order to implement the RapidHIT ID platform, validation studies are needed to define the performance and limitations of the system. Internal validation studies were undertaken with four early-production RapidHIT ID units. Reliable and concordant STR profiles were obtained from reference buccal swabs. Throughout the study, no contamination was observed. The overall first-pass success rate with an “expert-like system” was 72%, which is comparable to another current RDNA platform commercially available. The system’s second-pass success rate (involving manual interpretation on first-pass inconclusive results) increased to 90%. Inhibitors (i.e., coffee, smoking tobacco, and chewing tobacco) did not appear to affect typing by the instrument system; however, substrate (i.e., swab type) did impact typing success. Additionally, one desirable feature not available with other Rapid systems is that in the event of a system failed run, a swab can be recovered and subsequently re-analyzed in a new sample cartridge. Therefore, rarely should additional sampling or swab consumption be necessary. The RapidHIT ID system is a robust and reliable tool capable of generating complete STR profiles within the forensic DNA typing laboratory or with proper training in decentralized environments by non-laboratory personnel.

Multi-center evaluation of the cobas® Liat® Influenza A/B & RSV assay for rapid point of care diagnosis

Point of Care Testing (POCT) provides the capability for rapid laboratory test results in patient care environments where a traditional clinical laboratory is not available. POCTs have shorter turn-around times (TATs), they may be performed by non-laboratory personnel, and the need for transport time is eliminated. The Food and Drug Administration (FDA) recently granted Clinical Laboratory Improvements Amendment (CLIA) waiver status to the cobas® Influenza A/B & RSV assay, a rapid, accurate point-of-care test for Influenza and respiratory syncytial virus (RSV) performed on the Liat® System. The performance characteristics of this test were determined though a multi-site study consisting of different point of care testing environments. Prospectively collected Nasopharyngeal (NP) swabs from 1361 patients seen at 8 primary care clinics and 4 emergency departments (EDs) and 295 retrospectively identified specimens were tested for Influenza A/B and RSV on the cobas® Liat® platform. Performance characteristics were determined through comparison to ProFlu+, a laboratory-based PCR test for Influenza A/B and RSV (reference test). Discordant specimens were adjudicated following bi-directional sequencing. The cobas® Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for Influenza A, Influenza B, and RSV, respectively as determined from percent positive agreement (PPA) following comparison to the reference test. Sequencing confirmed cobas® Influenza A/B and RSV results in 49.2% of reference test discordant specimens, while crossing threshold data suggest increased sensitivity compared to the reference test. The cobas® Influenza A/B and RSV assay was found to be a rapid, sensitive POCT for the detection of these viruses, and provides laboratory-quality PCR-based diagnostic results in point of care settings.

Standardization of blood tube closure colors may be important in reducing tube selection errors of non-laboratory personnel

Abstract Errors in laboratory medicine contribute significantly to the overall risk of errors in healthcare. The majority of these laboratory errors occur in the pre-analytical phase. Control of pre-analytical variables is difficult because many steps are outside the control of the laboratory management. Pre-analytical errors may be reduced by active monitoring and control of all possible errors that are caused by non-laboratory personnel drawing blood, continuous training, use of quality indicators and implementation of standard procedures. Non-laboratory personnel make blood collection tube selection mostly according to the closure color, so standardization of color coding for blood tube closures could help reduce sample collection errors. It is important that European Federation of Clinical Chemistry and Laboratory Medicine calls all stakeholders in the healthcare sector to harmonize color coding for blood collection tube closures. Non-laboratory personnel drawing blood can be taught the additives in blood tubes and their functions to reduce errors during the sample collection stage. In addition, standardization of the closure colors of blood tubes should be supported, and non-laboratory personnel drawing blood should be informed when there is a change in the tube closure colors used by the hospital until this standardization is achieved.

Accuracy in HIV Rapid Testing among Laboratory and Non-laboratory Personnel in Zambia: Observations from the National HIV Proficiency Testing System.

BackgroundDespite rapid task-shifting and scale-up of HIV testing services in high HIV prevalence countries, studies evaluating accuracy remain limited. This study aimed to assess overall accuracy level and factors associated with accuracy in HIV rapid testing in Zambia.MethodsAccuracy was investigated among rural and urban HIV testing sites participating in two annual national HIV proficiency testing (PT) exercises conducted in 2009 (n = 282 sites) and 2010 (n = 488 sites). Testers included lay counselors, nurses, laboratory personnel and others. PT panels of five dry tube specimens (DTS) were issued to testing sites by the national reference laboratory (NRL). Site accuracy level was assessed by comparison of reported results to the expected results. Non-parametric rank tests and multiple linear regression models were used to assess variation in accuracy between PT cycles and between tester groups, and to examine factors associated with accuracy respectively.ResultsOverall accuracy level was 93.1% (95% CI: 91.2–94.9) in 2009 and 96.9% (95% CI: 96.1–97.8) in 2010. Differences in accuracy were seen between the tester groups in 2009 with laboratory personnel being more accurate than non-laboratory personnel, while in 2010 no differences were seen. In both PT exercises, lay counselors and nurses had more difficulties interpreting results, with more occurrences of false-negative, false-positive and indeterminate results. Having received the standard HIV rapid testing training and adherence to the national HIV testing algorithm were positively associated with accuracy.ConclusionThe study showed an improvement in tester group and overall accuracy from the first PT exercise to the next. Average number of incorrect test results per 1000 tests performed was reduced from 69 to 31. Further improvement is needed, however, and the national HIV proficiency testing system seems to be an important tool in this regard, which should be continued and needs to be urgently strengthened.

Accuracy in HIV rapid testing among laboratory and non-laboratory personnel in Zambia: Observations from the National HIV proficiency testing system

Background Despite rapid task-shifting and scale-up of HIV testing services in high HIV prevalence countries, studies evaluating accuracy remain limited. This study aimed to assess overall accuracy level and factors associated with accuracy in HIV rapid testing in Zambia. Methods Accuracy was investigated among rural and urban HIV testing sites participating in two annual national HIV proficiency testing (PT) exercises conducted in 2009 (n = 282 sites) and 2010 (n = 488 sites). Testers included lay counselors, nurses, laboratory personnel and others. PT panels of five dry tube specimens (DTS) were issued to testing sites by the national reference laboratory (NRL). Site accuracy level was assessed by comparison of reported results to the expected results. Non-parametric rank tests and multiple linear regression models were used to assess variation in accuracy between PT cycles and between tester groups, and to examine factors associated with accuracy respectively. Results Overall accuracy level was 93.1% (95% CI: 91.2–94.9) in 2009 and 96.9% (95% CI: 96.1–97.8) in 2010. Differences in accuracy were seen between the tester groups in 2009 with laboratory personnel being more accurate than non-laboratory personnel, while in 2010 no differences were seen. In both PT exercises, lay counselors and nurses had more difficulties interpreting results, with more occurrences of false-negative, false-positive and indeterminate results. Having received the standard HIV rapid testing training and adherence to the national HIV testing algorithm were positively associated with accuracy. Conclusion The study showed an improvement in tester group and overall accuracy from the first PT exercise to the next. Average number of incorrect test results per 1000 tests performed was reduced from 69 to 31. Further improvement is needed, however, and the national HIV proficiency testing system seems to be an important tool in this regard, which should be continued and needs to be urgently strengthened.

Feasibility of a targeted, very early infant HIV diagnosis algorithm in a resource-limited setting

Background: Studies evaluating accuracy in HIV testing in high HIVprevalencecountries remain limited. This studyaimed toassess the overall accuracy level and factors associated with accuracy in HIV rapid testing in Zambia. Methods & Materials: Accuracy was investigated among rural andurbanHIV testing sites participating in twoannual nationalHIV proficiency testing (PT) exercises conducted in 2009 (PT1; n=282) and 2010 (PT2; n=488). Testers included lay counselors, nurses, laboratory personnel and others. PT panels consisted of five serum samples conditioned into dry tube specimens (DTS) issued to testing sites by the national reference laboratory (NRL). Individual test site accuracy level was assessed by comparison of reported results to the expected PT panel results. Non-parametric rank tests and multiple linear regression models were used to assess variation in accuracy between tester groups and to examine factors associated with accuracy respectively. Results: The overall accuracy level was 93.1% and 96.9% in PT1 and PT2 respectively. Differences in accuracy were seen between the tester groups in the first exercise in 2009, with laboratory personnel being more accurate than non-laboratory personnel, while in 2010 no differences were seen. Comparing the two exercises, an improvement in accuracy level was seen among all non-laboratory tester groups, i.e. lay counselors (96.5% from 89.9%), nurses (96.1% from 93.5%) and others (98.5% from 95.0%), while performance remained stable among laboratory personnel (98.7% vs 98.7%). In both PT exercises, lay counselors and nurses had more difficulties interpreting results, with more occurrences of false negative, false positive and indeterminate results. Adherence to the national HIV testing algorithm and having received the standard HIV rapid testing training were associated with accuracy. Conclusion:The study showsan improvement in accuracyoverall and particularly among lay counselors from the first PT exercise to the next. Average number of incorrect test results per 1000 tests performed was reduced from 69 to 31. Further improvement is needed however, and the national HIV proficiency testing system seems to be an important tool in this regard which should be continued and needs to be urgently strengthened.

Alterations in rotation thromboelastometry (ROTEM®) parameters: point-of-care testing vs analysis after pneumatic tube system transport

Thromboelastometry as point-of-care (POC) testing enables the analysis of the clotting process at the bedside, providing rapid results to guide haemostatic therapy. However, POC testing utilizes medical staff who are managing critically ill patients, as non-laboratory personnel may not be sufficiently trained to run the devices. To resolve these problems, thromboelastometry can be performed in the central laboratory and rapid transport of samples can be accomplished via a pneumatic tube system (PTS). This study compares thromboelastometry parameters of blood samples analysed immediately with those analysed after PTS transport. In patients with normal haemostasis, two arterial blood samples were collected from each patient (n=92) in citrated plastic tubes to investigate the assays INTEM (n=35), EXTEM (n=27), and FIBTEM (n=30). One blood sample was analysed immediately, the other sample after PTS transport. Thromboelastometry was performed using a single ROTEM(®) device. The mean clot firmness values were significantly lower for PTS samples in both the INTEM (-0.7 mm cf. -1.1 mm) and EXTEM (-1.4 cf. -1.7 mm) assays. INTEM coagulation time (CT) was significantly lower in PTS samples with a mean difference of -13 s. EXTEM CT was significantly higher in PTS samples with a mean difference of +3.9 s. Thromboelastometry parameters of blood samples analysed after PTS transport are significantly altered compared with those analysed immediately. However, in patients with normal haemostasis, the alterations were small and without clinical consequence, implying that analysis after PTS transport is an acceptable alternative to prompt analysis at the bedside. Further studies should focus on patients with impaired haemostasis.