Test 1 Scientific Pubblications

Am J Clin Pathol. 2009 Feb;131(2):189-94

Erythrocyte sedimentation rate measurements by TEST 1 better reflect inflammation than do those by the Westergren method in patients with malignancy, autoimmune disease, or infection

Cha CH, Park CJ, Cha YJ, Kim HK, Kim DH; Honghoon, Bae JH, Jung JS, Jang S, Chi HS, Lee DS, Cho HI.

Department of Laboratory Medicine, University of Ulsan College of Medicine and Gangneung Asan Hospital, Gangneung, Korea.

Comment in:

• Am J Clin Pathol. 2009 Nov;132(5):805.
• Am J Clin Pathol. 2009 Nov;132(5):806.

We compared the TEST 1 (Alifax, Padova, Italy) and Westergren methods of measuring the erythrocyte sedimentation rate (ESR) to assess inflammation. The ESR was measured by both methods in 154 blood samples from patients with malignancy (n = 69), autoimmune disease (n = 44), or infection (n = 41). Total protein, albumin, and C-reactive protein (CRP) levels were measured in each plasma sample, and albumin and alpha(1)-, alpha(2)-, beta(1)-, beta(2)-, and gamma-globulin fractions were measured by capillary electrophoresis. TEST 1 ESR values were significantly lower than the Westergren values, by 10.9 mm/h. We found that the correlations of TEST 1 ESR values with inflammatory protein levels (total protein, globulin, CRP, and alpha(1)-, alpha(2)-, beta(2)-, and gamma-globulin) were better than those obtained using the Westergren method. These findings indicate that ESR measurements by TEST 1 reflect inflammation better than do those by the Westergren method in patients with malignancy, autoimmune disease, or infection.

PMID: 19141379 [PubMed - indexed for MEDLINE]

Clin Biochem. 2007 Apr;40(7):491-5. Epub 2007 Jan 8. Links

A new turbidimetric standard to improve the quality assurance of the erythrocyte sedimentation rate measurement

Piva E, Pajola R, Temporin V, Plebani M.

Dipartimento di Medicina di Laboratorio, Università degli Studi di Padova, Azienda Ospedaliera di Padova, Padova, Italy.

OBJECTIVES:
The erythrocyte sedimentation rate (ESR) determined using manual or semi-automated methods has usually been judged a simple procedure that could be performed without any form of Quality Control. According to this point of view, the ESR would seem a semi-quantitative test instead of a real hematological test with any clinical importance. The new millennium has consolidated ESR automation and a QC plan cannot be postponed.

DESIGN AND METHODS: Using Test1, an automated ESR analyzer, a new latex control material was evaluated and compared with fresh whole blood for quality control purposes. RESULTS:: The new latex control showed satisfactory reproducibility, precision, and "commutability" in comparison to quality control procedures that use fresh whole blood samples.

CONCLUSIONS: The new standard represents another advance in ESR testing improving the accuracy of automated TEST1 measurements.

PMID: 17306243 [PubMed - in process]

Clin Chem Lab Med. 2006;44(4):407-12

Comparison of TEST 1 with SRS 100 and ICSH reference method for the measurement of the length of sedimentation reaction in blood

Ozdem S, Akbas HS, Donmez L, Gultekin M.

Clinical Biochemistry Unit, Medical Faculty, Central Laboratory, Akdeniz University, Antalya, Turkey. ozdem@akdeniz.edu.tr

BACKGROUND:
We evaluated the measurement of length of sedimentation reaction in blood (LSRB) by TEST 1 and compared the results with those for the Westergren and Sed Rate Screener 100 (SRS 100) methods.

METHODS:
LSRB was measured in 113 paired blood samples.

RESULTS:
TEST 1 correlated significantly with the Westergren (r=0.94) and SRS 100 (r=0.90) methods with low bias (-0.29 and -1.92 mm/h, respectively) and limits of agreement (-14.5 to 13.9, and -23.4 to 19.6 mm/h, respectively). Hematocrit (Htc) correlated negatively with LSRB in TEST 1 (r=-0.54) and SRS 100 (r=-0.53) only in samples with high Htc (>/=35%). The bias and limits of agreement between TEST 1 and Westergren in samples with low (-1.46 and -22.3 to 19.3 mm/h) and high (0.43 and -7.29 to 8.14 mm/h) Htc were comparable to those between SRS 100 and Westergren (1.83 and -27.2 to 30.9 mm/h for low, 0.71 and -7.27 to 8.70 mm/h for high Htc samples). Total protein and fibrinogen correlated similarly with LSRB in both TEST 1 (r=0.23 and 0.48, respectively) and SRS 100 (r=0.30 and 0.51, respectively).

CONCLUSIONS:
The findings suggested that TEST 1 is a reliable, precise and accurate system for measurement of LSRB in clinical laboratories with high workload.

PMID: 16599833 [PubMed - indexed for MEDLINE]

Clin Chem Lab Med. 2006;44(7):904-6

Determination of the length of sedimentation reaction in blood using the TEST 1 system: comparison with the Sedimatic 100 method, turbidimetric fibrinogen levels, and the influence of M-proteins.

Ajubi NE, Bakker AJ, van den Berg GA.

Stichting KCL, Department of Clinical Chemistry, Leeuwarden, The Netherlands. n.e.ajubi@znb.nl

BACKGROUND:
Determination of the length of sedimentation reaction in blood (LSRB) is frequently used in daily practice to assess disease intensity. Recently, a micro-sedimentation method was introduced (TEST 1) that uses EDTA anti-coagulated blood samples. The aim of this study was to characterize this method by comparing it to a conventional Westergren method (Sedimatic 100). Furthermore, correlation between fibrinogen and the LSRB and the influence of M-proteins on the LSRB was investigated.

METHODS:
Unselected paired samples were used for comparison between the TEST 1 and Sedimatic 100 methods (n=733); fibrinogen was measured in EDTA samples (n=765) using a turbidimetric method. Furthermore, LSRB was measured in 29 EDTA samples in paired serum tubes from patients in whom an M-protein was detected.

RESULTS:
TEST 1 showed excellent correlation with the Sedimatic 100 method (y=1.00x; n=733; r=0.92, 95% CI 0.90-0.93; p<0.0001), and had no significant bias (0.15 mm/h, 95% CI -0.48 to 0.75 mm/h). Furthermore, TEST 1 LSRB showed satisfactory correlation with the fibrinogen content (y=3.13+0.06x; n=765; r=0.78, 95% CI 0.75-0.80; p<0.0001). In samples containing M-proteins, satisfactory correlation between the M-protein content and TEST 1 LSRB was found (y=0.69+0.22x; n=29; r=0.71, 95% CI 0.45-0.85; p<0.0001), while excellent correlation was found when only M-proteins of the IgM type were taken into account (y=-0.95+0.23x; n=9; r=0.93, 95% CI 0.71-0.99; p<0.0002).

CONCLUSIONS:
The results confirm previous reports that TEST 1 is a reliable method to measure the LSRB, and shows for the first time the quantitative relationship between TEST 1 LSRB and M-proteins, particularly those of the IgM type.

PMID: 16776642 [PubMed - indexed for MEDLINE]

Clin Chem Lab Med. 2003 Feb;41(2):232-7

Length of sedimentation reaction in blood: a comparison of the test 1 ESR system with the ICSH reference method and the sedisystem 15..

Romero A, Munoz M, Ramirez G.

Department of Haematology, H.C.U. "Virgen de la Victoria", Malaga, Spain.

The aim of this study was to compare the performance of the automatic TEST 1 ESR system, SIRE Analytical Systems (TEST 1), with that of the the Sedisystem 15, Becton Dickinson (SEDI), and the International Council for Standardization in Haematology reference method (Westergren) for measuring the length of sedimentation reaction in blood (LSRB). This reaction was measured in 418 paired blood samples drawn in K2-EDTA vacuum tubes and specific tubes from patients scheduled for routine LSRB measurement. The TEST 1 system uses micro-sedimentation and quantitative capillary photometry technology, whereas the SEDI uses a CCD camera. For Westergren, a 200 mm column with 3.0 mm internal diameter was used. Compared to Westergren, TEST 1 gives accurate values of LSRB in most of the samples (mean of differences: 0.99 +/- 10.4 mm; 95% CI, -0.807 to 2.78 mm; n =131). Similar results were obtained in the comparison with SEDI (mean of differences: -0.626 +/- 8 mm; 95% CI, -1.756 to 0.5 mm; n = 195). Compared to those of fresh blood samples, LSRB values were significantly lower in 24 h stored samples, either at 4 degrees C (21.5 +/- 2.3 vs. 19.4 +/- 2.2 mm; p (Spearman's coefficient of correlation): 0.981; n = 44) or at room temperature (19.1 +/- 2.5 vs. 16.2 +/- 2.1 mm; p: 0.903; n = 46). In conclusion, TEST 1 is a rapid, reliable system for automatic measurement of LSRB in standard K2-EDTA blood samples. It has a very low imprecision and maintains a good performance in 24 h stored samples. In addition, due to its operational characteristics (60 samples/20 min) it is a suitable tool for clinical laboratories with a high work load as well as for emergency laboratories.

Publication Types:
Comparative Study

PMID: 12667012 [PubMed - indexed for MEDLINE]

Clin Lab. 2002;48(9-10):459-62. Related Articles, Links

Internal quality control for erythrocyte sedimentation rate measured by TEST-1 Analyzer.

Giavarina D, Capuzzo S, Cauduro F, Carta M, Soffiati G.

Clinical Chemistry and Hematology Laboratory, San Bortolo Hospital, Vicenza Italy. giavarina@libero.it

The TEST 1 is a fully automated analyzer for measurement of the erythrocyte sedimentation rate. This system employs a particular capillary where blood is moved by a special hydrodynamic system. This original method is not able to measure stabilized samples for quality control, probably because stabilized erythrocytes offer a higher resistance to movement into the capillary, giving a distorted sedimentation curve. We evaluated whether the stability of collected EDTA samples, as declared by the producer company, was sufficient to use samples measured the day before as internal quality control samples. We also evaluated whether different tubes could modify the test results between stored and fresh samples. The difference between ESRs measured in fresh and stored samples are non-relevant after 24h and 48h, using both the tubes considered. The agreement between fresh and stored samples was better than that obtained by comparison with the Westergren method and can be used for the internal quality control procedure.

PMID: 12389704 [PubMed - indexed for MEDLINE]

Clin Chem Lab Med. 2001 May;39(5):451-4.

Length of sedimentation reaction in undiluted blood (erythrocyte sedimentation rate): variations with sex and age and reference limits.

Piva E, Sanzari MC, Servidio G, Plebani M.

Department of Laboratory Medicine, University-Hospital of Padua, Italy.

Although the length of sedimentation reaction in blood (LSRB) (commonly, but improperly called erythrocyte sedimentation rate, ESR) has long been used in clinical laboratories because it is simple and low-cost, its sensitivity and specificity are unsatisfactory. Usually, the values are reported using the Westergren method with sodium citrate-anticoagulated specimens. We used a new procedure, the TEST1, which measures the length of sedimentation reaction in undiluted K3EDTA anticoagulated blood samples following ICSH (International Committee for Standardization in Haematology) recommendations. Samples obtained from 840 reference individuals (430 females and 410 males, mean age 44 and 46.5 years respectively, range 1 to 90 years) were utilised to estimate the reference limits. The subjects, classified by sex, were subdivided into four statistically different age groups to determine the reference limits (2.5th and 97.5th percentiles). Sex difference was statistically significant in two age groups, from 14 to 50 (p < 0.0001) and from 50 to 70 years (p < 0.01). We did not observe significant sex difference within the age bracket from 1 to 14 years and from 70 to 90 years. In both sexes LSRB values increased with age, in significant correlation with fibrinogen concentration (p < 0.0001), and became significantly higher in subjects older than 70 compared to all the younger subjects (p<0.01 in females and p < 0.02 in males). Thus, we defined adequate reference ranges in elderly.

PMID: 11434396 [PubMed - indexed for MEDLINE]