CN113504369B - Individuation correction formula for eliminating positive interference of serum nerve-specific enolase detection caused by sample hemolysis and application thereof - Google Patents
Individuation correction formula for eliminating positive interference of serum nerve-specific enolase detection caused by sample hemolysis and application thereof Download PDFInfo
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Abstract
The invention belongs to the field of tumor marker detection, and in particular relates to an individuation correction formula for eliminating positive interference of serum nerve-specific enolase detection caused by specimen hemolysis and application thereof, wherein the formula is as follows: NSE corr＝NSEmeas-0.889×R×HImeas -3.159 XR; the method can be used for correcting the actually detected serum NSE value, so that the influence of high serum NSE value caused by the hemolysis phenomenon can be reduced, the serum NSE value calculated by the personalized correction formula is more similar to the actual value of the serum NSE, and the accuracy of the serum NSE detection can be improved; the invention further provides application of the individuation correction formula in diagnosis, recurrence and metastasis monitoring and curative effect evaluation of lung cancer and neuroblastoma, and interference or misleading of serum NSE false positive results on tumor diagnosis, recurrence and metastasis monitoring and curative effect evaluation can be effectively avoided.
Description
Technical Field
The invention belongs to the field of tumor marker detection, and particularly relates to an individuation correction formula for eliminating positive interference of serum nerve-specific enolase detection caused by specimen hemolysis and application thereof.
Background
Gamma subunit containing Neural Specific Enolase (NSE) is a major tumor marker for small cell lung cancer and neuroblastoma, and plays an irreplaceable important role in diagnosis, efficacy judgment and recurrence and metastasis monitoring of the two tumors. The serum NSE content of many small cell lung cancer patients is obviously increased, and the serum NSE content of some non-small cell lung cancer patients is also slightly increased. An increase in the NSE content in serum can be predictive of recurrent metastasis of tumors several months or even more than one year earlier than imaging. The biological half-life of NSE in human body is short, so that the NSE is very sensitive to effective response of treatment and is an important marker for judging the treatment effect.
Accurate serum NSE detection results can ensure the successful implementation of clinical diagnosis and treatment activities. However, the NSE concentration in serum is easily affected by hemolysis of blood specimens, because gamma subunit NSE contained in erythrocytes is about thirty-six times that in serum, and incorrect operation of each step before blood specimen collection, transportation, placement, centrifugation and other tests may lead to breakage of erythrocytes, release of NSE into serum, increase of serum NSE concentration, and interference or misleading of clinical diagnosis. Since normal human serum NSE content is very small (reference value range is 0-16.3 mug/L), even though hemolysis can not be recognized by naked eyes, obvious false positive interference can be generated, and clinically, the common serum NSE test result exceeds the reference value range, so that doctors and patients are questioned. Statistics show that the ratio of the hemolysis index of the serum samples of hospitalized patients is about 32.6% above the reference range. Further, the range of serum NSE concentrations between 16.3 μg/L and 50 μg/L is very confusing for clinic in the differential diagnosis of non-small cell lung cancer and small cell lung cancer, whether derived from tumor cell release or from specimen hemolysis is not distinguished, the ratio of the serum specimen hemolysis index of inpatients in this concentration range is up to 45% above the reference value range, and the highest hemolysis index 183 is also present in this concentration range. Thus, accurate serum NSE results must be taken into account if the specimen is hemolyzed. The invention provides an individuation correction formula capable of eliminating NSE detection positive interference caused by sample hemolysis and application thereof, which can detect serum NSE and serum hemolysis index by a Roche biochemical immune pipeline system (a Cobas c biochemical analysis series and a Cobas e immune analysis series) and can combine the information of the two.
Disclosure of Invention
In view of the problems pointed out in the background art, the present invention aims to provide an individualized correction formula for NSE detection results, which can eliminate false positive interference of serum NSE results caused by hemolysis of specimens to be detected, and provide application of the individualized correction formula in diagnosis, recurrence and metastasis monitoring and efficacy evaluation of lung cancer and neuroblastoma as another object of the present invention.
Based on the above purpose, the invention adopts the following technical scheme:
In a first aspect, the invention provides a personalized correction formula for eliminating positive interference of serum nerve-specific enolase detection caused by sample hemolysis, which is specifically as follows:
NSEcorr＝NSEmeas-0.889×R×HImeas-3.159×R；
Wherein NSE corr is the correction value of serum NSE calculated by the individuation correction formula; NSE meas is the detection value of serum NSE of the specimen to be tested; HI mens is the value of the test sample for hemolysis index; r is the ratio of NSE to HI of erythrocytes in the test specimen.
The self-control test proves that the personalized correction formula provided by the invention can eliminate the rise of NSE detection value caused by hemolysis, avoid NSE false positive result, and the NSE correction value calculated by the formula can reflect the real serum NSE value.
Further, when HI meas is less than or equal to 5 or NSE meas is less than or equal to 16.3, correction of NSE meas by the aid of the personalized correction formula is not needed; when HI meas > 5 and NSE meas > 16.3, NSE corr is corrected for NSE meas using the personalized correction formula described above.
The reference value range of NSE content of normal human serum is 0-16.3 mug/L, the reference value range of HI of normal human serum hemolysis index is 0-5, and median value is 2; therefore, when HI meas is less than or equal to 5 or NSE meas is less than or equal to 16.3, the serum to be detected is in the normal hemolysis index range or the detected serum NSE is in the normal reference range, and the detected serum NSE value is not required to be corrected by an individuation correction formula. When HI meas and NSE meas are greater than 16.3, the hemolysis index in the serum to be tested is beyond the normal range, and the influence of the hemolysis on the NSE detection of the serum needs to be considered, so NSE corr is obtained by correcting NSE meas by using the personalized correction formula.
In a second aspect, the present invention provides the use of the above-described personalized correction formula in the monitoring of recurrence and metastasis and efficacy assessment of lung cancer and neuroblastoma.
The serum NSE is an important marker for lung cancer and neuroblastoma, and the serum NSE detection accuracy directly influences the application effect of the marker in the recurrence and metastasis monitoring and curative effect evaluation of lung cancer and neuroblastoma, so that the personalized correction formula provided by the invention is adopted to correct the serum NSE detection result to obtain a result which can more truly reflect the serum NSE value, thereby being beneficial to eliminating the rise of the serum NSE detection result caused by hemolysis, effectively avoiding the interference or misleading of the serum NSE false positive result on the recurrence and metastasis monitoring and curative effect evaluation of tumors, and improving the application effect of the serum NSE as the tumor marker.
Further, based on the above application, when HI meas or NSE meas is 16.3 or less, correction of NSE meas using the above individualizing correction formula is not required; when HI meas > 5 and NSE meas > 16.3, it is assessed according to clinical need whether NSE meas needs to be corrected using the personalized correction formula described above to obtain NSE corr.
Further, clinical requirement assessment refers to whether the NSE meas of the subject in the current test is greater than the NSE meas of the subject in the last test; if the NSE meas detected at this time is smaller than the NSE meas detected at the last time, correcting the NSE meas detected at this time by using the personalized correction formula is not needed; if the NSE meas detected at this time is greater than the NSE meas detected at the last time, the individual correction formula is used to correct the NSE meas detected at this time to obtain a NSE corr, the corrected NSE corr is reported, and the NSE meas and the HI meas are remarked.
Namely, when the NSE value of the serum of the tested human body shows a descending trend, which indicates that the clinical significance is not warned, NSE meas is not required to be corrected by utilizing an individuation correction formula, and the NSE meas value can be reported and the hemolysis index HI meas can be noted. When the serum NSE value of the detected human body shows an ascending trend, particularly when the increment exceeds 25%, the method has a warning clinical significance, NSE meas is corrected by utilizing the individuation correction formula provided by the invention, a corrected NSE result (NSE corr) is reported, and NSE meas and HI meas are remarked.
In a third aspect, the present invention provides the use of the above-described personalized correction formula in the diagnosis of lung cancer and neuroblastoma.
Further, based on the application, when HI meas or NSE meas is 16.3, NSE meas need not be corrected using the personalized correction formula described above; when HI meas > and NSE meas > 16.3, NSE meas is corrected using the personalized correction formula described above to obtain NSE corr, NSE corr is reported, and NSE meas and HI meas are noted.
Similarly, when HI meas is less than or equal to 5 or NSE meas is less than or equal to 16.3, the serum to be detected is in the normal hemolysis index range or the detected serum NSE is in the normal reference range, and the detected serum NSE value does not need to be corrected by an individuation correction formula. When HI meas is greater than 5 and NSE meas is greater than 16.3, it means that there is a hemolysis index in the serum to be tested that exceeds the normal range, and the influence of hemolysis on the serum NSE detection needs to be considered, so that NSE corr needs to be obtained by correcting NSE meas by using the above-mentioned personalized correction formula, and the corrected serum NSE value (NSE corr) can reflect the real NSE value in the serum, which is beneficial to giving a relatively reliable diagnosis result based on the result.
Compared with the prior art, the invention provides an individuation correction formula for eliminating positive interference of serum nerve-specific enolase detection caused by sample hemolysis, and the formula is used for correcting the actually detected serum NSE value, so that the influence of high serum NSE value caused by the hemolysis phenomenon can be reduced, the serum NSE value calculated by the individuation correction formula is more similar to the true value of the serum NSE, and the accuracy of the serum NSE detection is improved. The invention further provides application of the individuation correction formula in diagnosis, recurrence and metastasis monitoring and curative effect evaluation of lung cancer and neuroblastoma, and interference or misleading of serum NSE false positive results on tumor diagnosis, recurrence and metastasis monitoring and curative effect evaluation can be effectively avoided.
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FIG. 1 is a schematic diagram of the applicable conditions of the personalized correction formula of the present invention.
Detailed Description
For a better description of the objects, technical solutions and advantages of the present invention, the present invention will be further described with reference to the following specific examples. It will be appreciated by persons skilled in the art that the specific embodiments described herein are for purposes of illustration only and are not intended to be limiting.
The test methods used in the examples are conventional methods unless otherwise specified; the materials, reagents and the like used, unless otherwise specified, are all commercially available.
Example 1 construction of personalized correction formula
The embodiment provides a construction method of an individuation correction formula for eliminating positive interference of serum nerve-specific enolase detection caused by sample hemolysis, which is obtained by a hemolysis excitation test, and comprises the following specific construction processes:
S1: establishment of control group serum hemolysis index reference value range: the control group serum was from healthy physical examination population, and serum NSE results were within the reference value range (0-16.3. Mu.g/L). Factors causing red blood cell disruption were tightly controlled in the pre-assay steps (blood sampling, transport and centrifugation), and serum hemolysis index (hemolysis index, HI) was measured using a Cobas c 702 biochemical analyzer. Through statistical analysis, the hemolysis index reference value range is determined to be 0-5, and the median value is determined to be 2.
S2: determination of the erythrocyte NSE/HI ratio: and (3) taking a proper amount of red blood cells from a blood conventional sample of a detected human body, washing for three times, dissolving the red blood cells by using distilled water to obtain red blood cell dissolving liquid, detecting the hemolysis index by using a Cobas c 702 biochemical analyzer, and detecting the NSE concentration by using a Cobas e 602 immunological analyzer, wherein the ratio between the NSE concentration value and the hemolysis index is the NSE/HI ratio of the red blood cells of the detected human body.
S3: hemolysis excitation test: and (3) a control group serum sample with the hemolysis index in a reference value range, wherein the serum NSE concentration covers the reagent detection linear range from a low value to a high value, red blood cell lysate is added into the serum sample, the control group serum sample is subjected to hemolysis excitation, and the hemolysis index HI and NSE concentration after the hemolysis excitation are measured.
S4: building an individualization correction formula: the individual correction formulas of the present invention were obtained by non-linear fitting of control group serum NSE values, erythrocyte NSE/HI ratios, NSE values after hemolysis challenge, and HI values. The specific formula is as follows:
NSEcorr＝NSEmeas-0.889×R×HImeas-3.159×R；
Wherein NSE corr is a serum NSE correction value calculated by an individuation correction formula; NSE meas is a serum NSE detection value obtained by detecting stimulated specimen serum through a Roche electrochemiluminescence immunoassay system; HI mens is the detection value of the Roche hemolysis index of the post-stimulated specimen; r is the ratio of NSE to HI of erythrocytes.
Example 2 clinical verification of personalized correction formula
In this example, an autologous control method is adopted, with a serum NSE detection value with normal hemolysis index as a reference, an NSE correction value is obtained by calculating an NSE value obtained by detecting after hemolysis excitation by using the personalized correction formula constructed in example 1, and the accuracy of the NSE value obtained by the personalized correction formula constructed in example 1 is evaluated by means of a difference analysis between the NSE correction value and the original NSE detection value. The specific test procedure is as follows:
47 in-patient serum specimens were selected, and all of the hemolysis indexes were normal. The baseline NSE value (covering the measurable range of reagent detection) was determined using an autologous control, followed by artificial hemolysis and re-determination of the post-hemolysis NSE value. The ratio NSE/HI of erythrocytes was determined from a conventional sample of blood from the same patient. The average difference between the NSE value corrected by the formula and the baseline NSE value before hemolysis was 1.92% by Bland-Altman analysis, the standard deviation of the difference was 5.23%, and the difference was independent of the magnitude of the hemolysis index. The 95% confidence limit for the average difference ranged from-8.33% to 12.77% and was less than the acceptable range (±20%) for NSE test items. The statistical analysis results show that: the performance of the individuation correction formula is not different from that of the original detection method. The serum NSE value calculated by the personalized correction formula is close to the true value of the serum NSE, so that the influence of high serum NSE value caused by the hemolysis phenomenon can be reduced, and the accuracy of serum NSE detection can be improved.
Example 3 application of personalized correction formula in diagnosis of lung cancer and neuroblastoma, recurrence and metastasis monitoring and efficacy assessment
The present embodiment provides the application of the personalized correction formula in the recurrence and metastasis monitoring and efficacy evaluation of lung cancer and neuroblastoma, as shown in fig. 1, when HI meas is less than or equal to 5 or NSE meas is less than or equal to 16.3, correction of NSE meas by the personalized correction formula is not required; When HI meas > 5 and NSE meas > 16.3, it is assessed according to clinical need whether NSE meas needs to be corrected using the personalized correction formula described above to obtain NSE corr. Clinical need assessment refers to whether the NSE meas of the subject in the current test is greater than the NSE meas of the subject in the last test; if the NSE meas detected at this time is smaller than the NSE meas detected at the last time, correcting the NSE meas detected at this time by using the personalized correction formula is not needed; If the NSE meas detected at this time is larger than the NSE meas detected at the last time, the personalized correction formula is used for correcting the NSE meas detected at this time to obtain NSE corr, Corrected NSE corr is reported and noted NSE meas and HI meas.
Based on the above principle, the serum NSE result audit is divided into the following three cases:
1. normal hemolysis index: i.e. HI meas is less than or equal to 5, and directly reports NSE detection results.
2. The hemolysis index is increased, but NSE results are within the reference value range, i.e. HI meas＞5,NSEmeas is less than or equal to 16.3, so that NSE is a safe value detected clinically, NSE values can be reported without correction, and the hemolysis index values are noted.
3. When the hemolysis index is increased and the NSE value exceeds the reference value range, namely HI meas is more than 5 and NSE meas is more than 16.3, and the clinical application is for recurrence and metastasis monitoring and curative effect evaluation, if the NSE meas value is smaller than the detection result of the NSE at the last time, the trend that serum NSE is lower and lower is shown, the warning clinical significance is avoided, the NSE value is not necessary to be corrected, and the hemolysis index value can be reported; clinically used for recurrence and metastasis monitoring and efficacy assessment, if the value is greater than the last NSE detection result, especially if the value is increased by more than 25%, serum NSE is more and more highly trend, and the method has warning clinical significance, and the corrected NSE result is reported by using the individuation correction formula, and the hemolysis index and the original NSE detection value containing the hemolysis influence are noted. For diagnosis, it is necessary to report corrected NSE results using a personalized formula and to note the hemolysis index and the original NSE detection values containing the effects of hemolysis.
Example 4 specific application example of personalized correction formula
The embodiment provides a specific application example of the personalized correction formula of embodiment 1, and the specific process is as follows:
1. Individuation index detection
(1) Serum NSE detection: the instrument adopts a Raschia immune analyzer cobas e series; the reagent adopts ELECSYS NSE detection kit.
(2) Serum hemolysis index HI detection: the instrument adopts a Raschia immune analyzer cobas c series; the reagents used were Serum Index Gen2 (SI 2).
(3) Erythrocyte NSE/HI ratio determination: mu.L of erythrocytes were pipetted from a blood conventional specimen into a 20mL centrifuge tube, 10mL of physiological saline was added, the erythrocytes were gently washed with a pipette, and then centrifuged at 1800 Xg for 5 minutes, and the supernatant was decanted to retain the bottom erythrocytes. Washing for three times to obtain concentrated erythrocyte, adding 1.5ml distilled water, shaking, centrifuging to obtain erythrocyte hemolysis, and measuring NSE and HI of erythrocyte hemolysis to obtain the ratio NSE/HI of erythrocyte.
Serum NSE, hemolysis index HI, and erythrocyte NSE/HI ratios of patient Hong Mou were tested using the above-described personalized index test.
2. Serum NSE detection result auditing report flow
Opening Hui Qiao a test information system (LIS), entering a tumor marker detection result auditing interface, enabling a patient Hong Mou to have a serum NSE detection value of 30.86 mug/L, exceeding a normal reference value range, comparing historical results, and finding that the last test result is 10.24 mug/L, and the difference between the two results is three times, so that the warning clinical significance exists. The hemolysis index was checked to be 69, which exceeds the normal value. Checking patient data, and diagnosing lung squamous carcinoma as a pathological diagnosis, which is a postoperative patient, and carrying out diagnosis at this time.
According to the NSE detection value, various consideration directions, suspected small cell lung cancer, suspected non-small cell lung cancer, or tissue type conversion of the small cell lung cancer, or suspected metastasis and recurrence can exist in clinical aspects. To integrate the clinical situation, it is necessary to correct the value of NSE affected by hemolysis in order to avoid misleading clinical diagnosis and treatment.
A regular sample of blood was taken on the same day of flood and the ratio NSE/HI of red blood cells was determined to be 0.309. Mu.g/L.
The corrected NSE correction value is calculated using the correction formula:
NSEcorr＝NSEmeas–0.889×R×HImeas–3.159×R＝30.86–0.889×0.309×69–3.159×0.309＝10.93μg/L
the corrected serum NSE result is 10.93 mug/L, the positive clinical significance in diagnosis is eliminated in the range of the reference value (0-16.3 mug/L), and the difference between the corrected result and the last historical result is 6.73%, the increase is not more than 25%, and the warning clinical significance of recurrence and metastasis is avoided.
The final serum NSE results were reported as 10.93 μg/L, remarks on report: 1. sample hemolysis index 69, and the original detection result affected by sample hemolysis is 30.86 mug/L; 2. the reported result corrected by the individualization formula was 10.93. Mu.g/L, which was only used for clinical reference.
Finally, it should be noted that the above embodiments are only for illustrating the technical solution of the present invention and not for limiting the scope of the present invention, and although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solution of the present invention may be modified or substituted equally without departing from the spirit and scope of the technical solution of the present invention.
Claims (2)
1. The application of an individuation correction formula in preparing products for recurrence and metastasis monitoring and curative effect evaluation of lung cancer and neuroblastoma is characterized in that the individuation correction formula is as follows:
NSEcorr=NSEmeas - 0.889×R×HImeas - 3.159×R；
Wherein NSE corr is a serum NSE correction value calculated by the individuation correction formula; NSE meas is the detection value of serum NSE of the specimen to be tested; HI mens is the value of the test sample for hemolysis index; r is the ratio of NSE to HI of erythrocytes in the sample;
When HI meas is less than or equal to 5 or NSE meas is less than or equal to 16.3, correcting NSE meas by using the individualization correction formula; when HI meas > 5 and NSE meas > 16.3, NSE corr is obtained by correcting NSE meas using the personalized correction formula.
2. The application of an individuation correction formula in preparing products for diagnosing lung cancer and neuroblastoma is characterized in that the individuation correction formula is as follows:
NSEcorr=NSEmeas - 0.889×R×HImeas - 3.159×R；
Wherein NSE corr is a serum NSE correction value calculated by the individuation correction formula; NSE meas is the detection value of serum NSE of the specimen to be tested; HI mens is the value of the test sample for hemolysis index; r is the ratio of NSE to HI of erythrocytes in the sample;
When HI meas is less than or equal to 5 or NSE meas is less than or equal to 16.3, correcting NSE meas by using the individualization correction formula; when HI meas > and NSE meas > 16.3, correction of NSE meas using the personalized correction formula yields NSE corr, reports NSE corr, and notes NSE meas and HI meas.
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