WO2020193839A2 - Procédé et dispositif pour la détection visuelle du niveau d'aptitude d'un échantillon isolé de sang pour sa validation dans des analyses cliniques - Google Patents

Procédé et dispositif pour la détection visuelle du niveau d'aptitude d'un échantillon isolé de sang pour sa validation dans des analyses cliniques Download PDF

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WO2020193839A2
WO2020193839A2 PCT/ES2020/070344 ES2020070344W WO2020193839A2 WO 2020193839 A2 WO2020193839 A2 WO 2020193839A2 ES 2020070344 W ES2020070344 W ES 2020070344W WO 2020193839 A2 WO2020193839 A2 WO 2020193839A2
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stage
sample
scale
color
hemolysis
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PCT/ES2020/070344
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English (en)
Spanish (es)
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WO2020193839A3 (fr
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Ismael ORTUÑO SORIANO
Emilio VARGAS CASTRILLÓN
Leticia Carmen SIMÓN LÓPEZ
Mª Dolores OCHOA MAZARRO
Sergio LUQUERO BUENO
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Universidad Complutense De Madrid
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Publication of WO2020193839A2 publication Critical patent/WO2020193839A2/fr
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue

Definitions

  • the present invention falls within the field of clinical analysis, more specifically, in the identification of the degree of hemolysis exhibited by isolated blood samples.
  • Hemolysis is a phenomenon that can alter the results of analytical parameters. If no cross-interference occurs, generally, hemolysis increases the concentration of those determinations that present high concentrations at the intracellular level, and decreases those that are found in low concentrations. For example, Italo Moettess Salda ⁇ a collects a study of the interference of hemolysis on 25 biochemical constituents, of which 16 presented clinically significant interference (Salda ⁇ a, I.M. An Fac Med 2015; 76 (4): 377-384).
  • the International Organization for Standardization addresses the requirements of the quality system to be applied in the clinical laboratory (ISO 15189: 2012), focused on patient safety. Venipuncture blood samples are the most common type of biological sample collected and sent to laboratories for analysis, diagnosis, and therapeutic monitoring. According to the action guidelines of the World Health Organization, the laboratory must detect the presence of hemolysis in the isolated sample to analyze and assess whether it is a reason for rejection for any of the requested determinations (World Health Organization. Diagnostic Imaging and Laboratory Technology. (2002). Use of anticoagulants in diagnostic laboratory investigations. Geneva: World Health Organization. Available at: http: / AAAAAA /, wh3 ⁇ 4 snt / sris / handje / 10665/65957).
  • Procedure and device for the visual detection of the degree of suitability of an isolated blood sample for its validation in clinical analysis Procedure and device for the visual detection of the degree of suitability of an isolated blood sample for its validation in clinical analysis.
  • One aspect of the present invention relates to a method for identifying the suitability of an isolated blood sample for subsequent clinical analysis thereof.
  • This procedure comprises a step in which the isolated blood sample to be analyzed is compared with a scale degraded according to the visual intensities of hemolysis in plasma, which incorporates the entire range of color intensities from 55 ° to 00 °. and 0 to 351 ° or, being 00 ° the red color on the color wheel. These values reflect the number of degrees of rotation around a double colored cone starting from the color red (00 °).
  • a degraded scale is understood to be a colorimetric scale in which the intensity of the color increases progressively, continuously.
  • the tone in degrees, saturation and brightness in a double cone of colors and the HSL model were used, as well as information from 277 samples of plasma.
  • the double cone is made up of two cones that sit on the same circular base and whose vertices are aligned with the center of the circle of said base.
  • the upper and lower vertices correspond to the luminosity, white (100%) and black (0 %) respectively; the distance to the axis with saturation, whose maximum intensity of each color is represented by 100% and the minimum intensity, which corresponds to a gray shadow, with 0%; and the angle corresponds to the color tone.
  • Hue resides along the circular base of the double cone, forming a color wheel that is defined by three primary values by their position on the color wheel. The position of the three primary values are normalized, forming a triangle, as follows: primary red is located at 0 or, the primary green to 120 ° and the primary blue 240 °, back to red when returned to the origin of the circle at 360 °.
  • CMYK model (from the acronym Cyan, Magenta, Yellow and Key) is a subtractive color model that allows to represent a wide range of colors and is well adapted to industrial environments. This model is based on the mixture of pigments of cyan, magenta, yellow and black colors to create others and is the one that has been used to convert the colors obtained according to the HSL model to printing values.
  • one aspect of the invention refers to a method for visually identifying the degree of suitability of an isolated blood sample for validation in clinical analysis, by detecting the degree of hemolysis that the sample has suffered, which includes:
  • stage 1 55 ° -44 °
  • stage 2 43 ° -38 °
  • stage 3 37 ° -26 °
  • stage 4 25 ° -16 °
  • stage 5 15 ° -07 °
  • stage 6 06 ° -01 °
  • stage 7 00 ° -351 °, whose harmonization in saturation and brightness, respectively, are: stage 1: 35% - 44%, 99% - 89%; stage 2: 47% -50%, 90% -90%; stage 3: 50% -60%, 93% - 89%; stage 4: 68% -80%, 95% - 80%; stage 5: 71% -81%
  • each of the 7 stages of the degraded scale corresponds to an intensity of hemolysis that implies the potential alteration of certain blood parameters, the number of which increases as the degree of hemolysis increases in such a way that the number of alterations are cumulative to as the intensity of hemolysis in plasma EDTA K2 / K3 increases in healthy adults.
  • the plasma of an isolated blood sample is the object of analysis of the parameters stated in the previous paragraph, it is visually evaluated its intensity of hemolysis and is assigned to one of the 7 stages. Later, it will be analyzed and the result of each altered parameter can be evaluated in combination with the stage to which it had been assigned. The stage number to which the sample is assigned must accompany the result of the parameters evaluated in the report, as an alert to the person responsible for the validation of results. Thus, the results will be validated or rejected if, not being in a normal range, its corresponding stage of hemolysis reaches a sufficient intensity to be compatible with a potential alteration of the results.
  • the plasma from an isolated blood sample is analyzed for additional parameters to those listed in the previous paragraph, its intensity of hemolysis is visually evaluated and assigned to one of the 7 stages. Subsequently, it will be analyzed and the result of each altered parameter can be evaluated in combination with the stage of the degraded scale. The number of the stage with which the sample is identified must accompany the sample result in the report, as an alert to the person responsible for validating the results. Thus, the results will be validated or rejected if, not being within a normal range, its corresponding stage of hemolysis reaches a sufficient intensity to be compatible with a potential alteration of the results of the parameters analyzed.
  • the person in charge of validation of the laboratory can issue the judgment of suspicion of an alteration of the plasma sample and not to a potential pathology of the patient, Or, it can make a judgment of altered results not expected due to a certain intensity of hemolysis in the sample. Therefore, by means of the method of the invention, the person responsible for the clinical analysis can decide whether or not to carry out a second analysis of a second isolated blood sample.
  • the color degraded scale preferably occupies a surface 210 mm high by 297 mm long, each stage corresponding to a size of 105 mm high by 41 mm wide.
  • the set of the scale colors occupies 105 mm high by 287 long, with a margin of 52.5 mm in the upper part as in the lower part and 5 mm in the right part as in the left part in which the color is , preferably, matt white, and it can be manufactured in practically any material: paper, cardboard, foam board, plastic, metal.
  • a second aspect of the present invention refers to a degraded color scale to identify the degree of suitability of an isolated blood sample for validation in clinical analysis, depending on the degree of hemolysis that said sample presents, which includes the entire range of color intensities from 55 ° to 00 ° and from 00 ° to 351 °, where 00 ° is the red color in the double cone chromatic circle and in which said range of intensities is divided into 7 intervals of equal size corresponding to the following stages: stage 1: 55 ° -44 °; stage 2: 43 ° -38 °; stage 3: 37 ° -26 °; stage 4: 25 ° -16 °; stage 5: 15 ° -07 °; stage 6: 06 ° -01 °; stage 7: 00 ° -351 °
  • Stage 1 35% - 44%, 99% - 89%
  • stage 2 47% -50%, 90% -90%
  • stage 3 50% -60%, 93%
  • a device can be made in which the scale preferably occupies a surface 210 mm high by 297 mm long, each stage corresponding to a size of 105 mm high by 41 mm wide, the set of scale colors occupies 105 mm high by 287 long, with a margin of 52.5 mm at the top as in the bottom and 5 mm on the right and left in which the color is preferably matte white.
  • the device can be made of practically any material: paper, cardboard, foam board, plastic, metal.
  • Figure 1 Degraded scale for visual detection of hemolysis with indication of the values used for its preparation.
  • Figure 2 Example of a degraded scale for the visual detection of hemolysis, to be used in the clinical analysis laboratory.
  • the sample selection criteria were the following:
  • the scale was designed to include from 55 ° to 00 ° and from 00 ° to 351 °, with 00 being the red color in the chromatic circle at the base of the double cone. These values reflect the number of degrees of rotation along the double cone base color circle starting from the color red (00 °).
  • the 277 samples were evaluated by spectrophotometry as indicated in Example 3.
  • the color tones expressed in degrees and the spectrophotometry results are shown in Figure 1: the degrees at the top of the degraded scale and the hemolysis absorbances at the bottom of the scale degrades. In both cases, the values used in the following examples for the study of concordances and in the statistical tests carried out in the validation process of the hemolysis detection method in isolated blood samples have been marked in bold. From top to bottom, figure 1 shows:
  • the total of the scale was divided into 7 stages, that is, into 7 fragments of equal size that represent 7 phases or successive stages of hemolysis that an isolated sample of blood can present, of less to greater intensity of hemolysis.
  • the scale was designed with a size of 105 mm high by 287 mm long, with each stage corresponding to a size of 105 mm high by 41 mm wide.
  • a device was manufactured using 90 gram paper, in matt colors. As can be seen in Figure 1, the 7 stages into which the scale was divided were delimited by the intervals detailed in Table 2:
  • the scale was designed so that all the stages occupy the same space in the total scale, which avoids visual distortion biases.
  • stage 1 A blood sample with stage 1 hemolysis is considered not to have a clinically relevant impact on most blood measurement parameters in plasma.
  • stage 1 only one parameter is altered, which, furthermore, is not routinely assessed in clinical tests; in stage 2, a parameter that is analyzed more routinely is potentially altered, and in subsequent stages even more values are altered.
  • a NanoDrop TM 2000 Spectrophotometer (Thermo Fisher Scientific Inc., Wilmington, United States of America) was used, with a broad ultraviolet-visible spectrum (190-840 nm) and requiring microvolumes of 0.5 to 2 ⁇ l of initial sample. Using this spectrophotometer, highly concentrated samples can be measured without the need to dilute them beforehand.
  • the absorbance of deoxyhemoglobin was measured across the spectrum through 2 ⁇ l of plasma.
  • the plasma of each sample was obtained as indicated in example 4.
  • the NanoDrop TM 2000 Spectrophotometer was calibrated with 2 ml of distilled water, the measurement was carried out and, once the dimensionless unit of absorbance was obtained in the NanoDrop 2000 / 2000c software 1.6.198 Thermo Fisher Scientific Inc., cleaned with disposable tissues.
  • 2 ml of plasma was taken from an isolated blood sample and analyzed, repeating the process at least 3 times, wiping with a tissue between each measurement.
  • the zone of the NanoDrop TM 2000 Spectrophotometer that comes into contact with the sample was cleaned with 2 ⁇ l of distilled water and 1 or 2 measurements were made to corroborate that there was no carryover from the analysis of one sample to the next.
  • the observers received a 10-minute pre-training to perform the evaluations. Subsequently, they were allowed to take a maximum of one minute for the evaluation of each sample.
  • Plasma was obtained from each isolated blood sample. For this, the samples were collected in EDTA (ethylenediaminetetraacetic acid) tubes since it is the most used as an anticoagulant because it interferes with very few blood determinations. Plasma was obtained by centrifuging each sample at 3400 rpm for 10 minutes at 4 ° C, in a maximum of two hours after sampling. The plasma content was transferred to the largest possible number of 1.4 ml tubes (Wilmut, W-2DPH 1.40 ml, Nirco, S.L., Barcelona, Spain). The first tube was standardized to a minimum volume of 150 ⁇ l and was identified with a V in the upper part of the tube, where there was no plasma so as not to interfere with color visualization.
  • EDTA ethylenediaminetetraacetic acid
  • a one-sided sample calculation of the observed proportion with respect to a reference was carried out, with an alpha error of 5% and a power of 80%, one-sided test.
  • the reference proportion was 46.6% based on a study in which, of 15 samples identified with the presence of hemolysis through spectrophotometry, 8 of them were not visually detected and 7 could be detected through the human eye (Shash , JS et al. PLoS ONE 2016; 11 (4) 1-12).
  • the objective was to achieve a concordance of at least 85%, justified by being a value of certainty considered sufficiently satisfactory; which was considered optimal for detecting the intensity of hemolysis at each stage.
  • H0 Hemolysis intensity concordance across visual stages is not optimal ⁇ 0.70.
  • H1 Hemolysis intensity concordance across visual stages is optimal 3 0.85; at least 0.85.
  • the Spearman correlation coefficient was used to observe the trend and strength of the relationships between variables; Cohen's Kappa index to know the concordances and disagreements of the stages; the Kaiser-Meyer-OIkin (KMO) test and Bartlett's sphericity test (chi-square model); the intraclass correlation coefficient for the reliability of spectrophotometry on all repeated absorbance measurements.
  • the SPSS version 23 statistical program and the Microsoft Excel XLSTATA program were used to address the validity of predictive criteria.
  • stage 1 validated by 14 samples stage 2 validated by 16 samples
  • stage 3 validated by 10 samples stage 4 validated by 10 samples
  • stage 5 validated by 9 samples stage 6 by 9 samples and stage 7 by 12 samples.
  • a Cohen Kappa index of 0.491 was obtained in the test and 0.270 in the retest. It is considered a moderate and acceptable agreement, respectively, according to Landis and Koch (Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May; 37 (5): 360-3).
  • the intraclass correlation coefficient (ICC) of the repeated absorbance measurements of each sample was determined to represent the stability of the reference instrument measurements.
  • an ICC of 0.995 was obtained in a 95% confidence interval (CI) (0.992 - 0.996).
  • Table 4 represents a significant increase in absorbance across the stages; through a Spearman correlation:
  • stage 1 0.018; stage 2: 0.009; stage 3: 0.013; stage 4: 0.015; stage 5: 0.055; stage 6: 0.036; and stage 7: 0.277.
  • table 6 shows the global criterion measurements of the scale in the re-test, that is, from stages 2 to 7 with respect to stage 1.
  • the stated concordances refer to correct absolute classifications with implicit clinical relevance .
  • the prevalence of stage 1 was calculated to be 0, 188.
  • Stage 2 Concordances of 0.886 in a 95% confidence interval (CI) (0.780-0.780), discrepancies of 0.1 14 95% CI (0.009-0.220), sensitivity of 0.80 in a 95% CI (0.577 -0.923), specificity of 1.00 in a 95% CI (0.757-1.00), false positive rate of 0.00, false negative rate of 0.200 in a 95% CI (0.040-0.360).
  • Prevalence of 0.571 in a 95% CI (0.407-0.735), Positive Predictive Value (PPV) of 1.00 in a 95% CI (1.00-1.00), Negative Predictive Value (NPV) of 0.952 in a CI 95% (0.857-1.00).
  • Relative risk (RR) of 4.750 in a 95% CI (2.1 12-10.681).
  • Stage 3 Concordances of 0.960 in 95% CI (0.883-1.00), discrepancies of 0.040 in 95% CI (0.000-0, 117), sensitivity of 0.90 in 95% CI (0.571-1, 000), specificity of 1.00 in a 95% CI (0.757-1.00), false positive rate of 0.00, false negative rate of 0.100 in a 95% CI (0.000-0.257).
  • Stage 4 Concordances of 0.600 in 95% CI (0.438-0.762), discrepancies of 0.400 in 95% CI (0.238-0.562), sensitivity of 0.300 in a 95% CI (0, 145-0.522), specificity of 1,000 in a 95% CI (0.757-1.00), a false positive rate of 0.000, a false negative rate of 0.700 in a 95% CI (0.517-0.883).
  • Stage 5 Concordances of 0.947 in 95% CI (0.847-1, 000), disagreements of 0.053 with 95% CI (0.000-0, 153), sensitivity of 0.750 in a 95% CI (0.290-0.960), specificity of 1, 000 at a 95% CI (0.757-1.00), false positive rate of 0.000, false negative rate of 0.250 at a 95% CI (0.000-0.550).
  • Stage 6 Concordances of 0.842 in 95% CI (0.678-1.000), discrepancies of 0.158 in 95% CI (0.000-0.322), sensitivity of 0.250 in a 95% CI (0.040-0.710), specificity of 1.000 in a 95% CI (0.757-1.00), a false positive rate of 0.000, a false negative rate of 0.750 in a 95% CI (0.450-1,000).
  • Prevalence of 0.211 in a 95% CI (0.027-0.394), PPV of 1,000 in a 95% CI (1,000-1,000), NPV of 0.913 in a 95% CI
  • Stage 7 Concordances of 1,000 in 95% CI (1,000-1,000), discrepancies of 0,000 in 95% CI (0,000-0,000), sensitivity of 1,000 in 95% CI (0.590-1,000) ), specificity of 1,000 at 95% CI (0.757-1, 000), false positive rate of 0.000, false negative rate of 0.000 at 95% CI (0.000-0.000).
  • stage 4 With regard to criterion validity, the overall proportion of concordances is considered satisfactory. These concordances are distributed non-proportionally among their stages, but, with the exception of stage 4, all the others reach a satisfactory value (greater than or equal to 70%). Stage 4, despite not achieving a satisfactory result, not only results in a close value, but the value of 0.70 is among the possible values of concordances collected in the interval of stage 4 in the sample studied with a 95% probability of success. Furthermore, stage 4 maintains a strong relationship between visual assessment and absorbance analysis, suggesting a robust orientation of potentially altered parameters upon reaching the intensity of hemolysis corresponding to stage 4. All stages are useful for the detection of absence of hemolysis with clinical impact; 100% specificity and 0% false positives.
  • Sensitivity 3 70% except stages 4 and 6.
  • the false negative rate is small, except for stages 4 and 6.
  • All stages predict the corresponding amount of hemolysis, adequately (PPV 3 70%).
  • NPV £ 70% probably influenced by the low prevalence, in stages 2 to 7 included it is satisfactory (NPV 3 70%).
  • the likelihood ratio that a hemolyzed sample is not identified as such and its magnitude is low, except in stage 4, which has not found a discriminatory characteristic.
  • the probability of screening in the identification of hemolyzed versus non-hemolyzed samples is greater, although the increase is not linear.
  • the scale reflects a criterion validity, not a construct validity, for the sample size approached; it could be due to insufficient capacity in field work. However, it is closely related to the upper limit of the confidence interval of such calculated value.
  • the degraded scale of hemolysis intensity is a useful tool that reflects the reality of the underlying theoretical construct with a sufficiently satisfactory impact of clinical benefits.

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Abstract

La présente invention concerne un procédé et un dispositif pour la détection visuelle du niveau d'aptitude d'un échantillon isolé de sang pour sa validation dans des analyses cliniques. La présente invention se rapporte à un procédé permettant d'identifier visuellement le niveau d'aptitude d'un échantillon isolé de sang pour la validation de son analyse clinique postérieure, tenant compte du niveau d'hémolyse de l'échantillon. Ce procédé inclut la comparaison du plasma de l'échantillon avec une échelle à dégradation progressive, continue, divisée en sept stades qui se répartissent, avec une taille identique, de 55° à 00° et de 00° à 351°, 00° étant la couleur rouge dans le cercle chromatique du modèle à double cône. La présente invention se rapporte également à ladite échelle à dégradation et au dispositif qui la contient, qui peut être élaborée en matériaux distincts (papier, carton, carton-plume, plastique, métal).
PCT/ES2020/070344 2019-03-28 2020-05-26 Procédé et dispositif pour la détection visuelle du niveau d'aptitude d'un échantillon isolé de sang pour sa validation dans des analyses cliniques WO2020193839A2 (fr)

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ES201900050A ES2733148B2 (es) 2019-03-28 2019-03-28 Procedimiento y dispositivo para la detección visual del grado de aptitud de una muestra aislada de sangre para su validación en análisis clínicos

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