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Product description: vidas® estradiol ii is an automated quantitative test for use on the vidas family of instruments for the quantitative measurement of total 17 ¿ -estradiol in human serum or plasma (lithium heparin), using the elfa technique (enzyme linked fluorescent assay).The vidas® e2 ii assay is intended for use as an aid in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.Range of expected values in a clinically healthy population, the following values were found: men (n = 173) < 62 pg/ml.Women: follicular phase: (n = 129): 18 - 147 pg/ml; pre-ovulatory peak: (n = 33): 93 - 575 pg/ml; luteal phase (n = 131): 43 - 214 pg/ml; menopause (n = 26): < 58 pg/ml.Issue description: on (b)(6) 2021, a customer from (b)(6) notified biomérieux of obtaining overestimated results when testing patient samples with vidas estradiol ii 60 tests (ref.30431, batch number 1008872270, expiry date 19jul2022) compared to another method (siemens).The customer confirmed that each sample was from a different patient; therefore, nine patients are involved.(b)(6): ivds5206642 4406.42 pmol/l; ivd1202556 4222.59 pmol/l; siemens 4065.65.(b)(6): ivds5206642 807.4 pmol/l; ivd1202556 707.87 pmol/l; siemens 549.25.(b)(6): ivds5206642 1656.09 pmol/l; ivd1202556 1573.77 pmol/l; siemens 1552.45.(b)(6): ivds5206642 1161.63 pmol/l; ivd1202556 1234.62 pmol/l; siemens 820.38.(b)(6): ivds5206642 4925.29 pmol/l; ivd1202556 4678.81 pmol/l; siemens 4433.46.(b)(6): ivds5206642 1859.85 pmol/l; ivd1202556 1791.18 pmol/l; siemens 1527.25.(b)(6): ivds5206642 827.25 pmol/l; ivd1202556 789.31 pmol/l; siemens 673.69.(b)(6): ivds5206642 453.83 pmol/l; ivd1202556 485.87 pmol/l; siemens 464.13.(b)(6): ivds5206642 209.45 pmol/l; ivd1202556 222.7 pmol/l; siemens 146.35.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 30431 is not registered in the united states.The u.S similar device is product reference 30431-01.
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This report was initially submitted following notification from a customer in spain regarding overestimated results when testing patient samples with vidas® estradiol ii 60 tests (ref.(b)(4), batch number 1008872270, expiry date 19jul2022) compared to another method (siemens).A biomérieux internal investigation has been completed with the following results: clinical context: all patients were undergoing assisted reproduction treatment or follicle or endometrial maturation depending on the cycle.The detail of the clinical context per patient and their treatment is not known.Investigation device history record the review did not highlight any issue during manufacturing vidas estradiol ii ref (b)(4) lot 1008872270.There was no capa, no non conformity on vidas estradiol ii ref (b)(4) linked to customer's complaint.Complaint analysis the analysis of complaints recorded against this lot did not reveal any quality issue for this lot or any systemic quality issue.Test/analysis performed customer¿s material patient samples were received frozen at -30°c.Control charts analysis the complaint laboratory analyzed the results of four (4) internal samples (targets 301, 983.91, 2658.05, 6230.26 and 8550.55 pmol/l) on seven (7) different batches of vidas estradiol ii including customer¿s lot 1008872270.The analysis of the control charts showed that all results were within specifications.Customer¿s lot was in the trend of the other lots.Tests performed by complaint laboratory on internal samples: the complaint laboratory tested three (3) internal samples with concentrations distributed at different level of vidas estradiol ii curve (targets 451.57, 1563.99 and 7728.17 pg/ml) with the retain kit vidas estradiol ii lot 1008872270.All sample results were within their expected specifications.There was globally no significant evolution over time of the batch mentioned by the customer since the batch release.On customer¿s samples the complaints laboratory tested the customer¿s samples with the retain kit vidas estradiol ii lot 1008872270.The customer¿s results were reproduced: sample (b)(6) = 676.77 pmol/l, sample (b)(6) = 1121.7 pmol/l, sample (b)(6) = 1745.50 pmol/l, sample (b)(6) = 830.34 pmol/l, sample (b)(6) = 205.41 pmol/l.Analysis of customer¿s results: based on guidelines related to biological variation: eflm biological variation, estimated median cv within subject = 15% ic [13.3 ¿ 16.5].¿quality goals for hormone testing, (b)(6), 1990, (b)(6) biochem, 27, 353-8¿ cv i = 21.7%.The following was observed: five (5) samples showed overestimated results (results with significant difference) compared to siemens method: sample (b)(6) : 807.4 pmol/l and 707.87 pmol/l on vidas and 549.25 pmol/l on siemens.Sample (b)(6) : 1161.63 pmol/l and 1234.62 pmol/l on vidas and 820.38 pmol/l on siemens.Sample (b)(6) : 1859.85 pmol/l and 1791.18 pmol/l on vidas and 1527.25 pmol/l on siemens.Sample (b)(6) : 827.25 pmol/l and 789.31 pmol/l on vidas and 673.69 pmol/l on siemens.Sample (b)(6) : 209.45 pmol/l and 222.7 pmol/l on vidas and 146.35 pmol/l on siemens.Four (4) samples did not show any obvious difference according to guidelines specifications: sample (b)(6): 4406.42 pmol/l; 4222.59 pmol/l on vidas and 4065.65 pmol/l on siemens.Sample (b)(6): 1656.09 pmol/l; 1573.77 pmol/l on vidas and 1552.45 pmol/l on siemens.Sample (b)(6): 4925.29 and 4678.81 pmol/l on vidas and 4433.46 pmol/l on siemens.Sample (b)(6): 453.83 and 485.87 pmol/l on vidas and 464.13 pmol/l on siemens.The interpretation of the fertility test like estradiol is impossible without a detailed clinical context for each patient.Only the study of the kinetic of estradiol, combined with other fertility markers, allows to define in which part of the cycle the patient was at the time of the collection blood, ie follicular, pre-ovulatory or luteal.Package insert information as mentioned in the package insert, the interpretation of vidas estradiol results should take into account the following points: in case of methods comparison, the storage/transport condition is a critical point: ¿sample stability samples can be stored at +2°c/+8°c in stoppered tubes for up to 3 days.If longer storage is required, freeze the sera or plasma at -19°c/-31°c for up to 4 months.Avoid successive freezing and thawing.There is no gold standard except id-gcms so we cannot compare quantitatively different techniques without detailed clinical information.Chapter result and interpretation ¿the vidas® estradiol ii assay is calibrated against the id-gcms (isotope dilution - gas chromatography mass spectrometry) technique".Any concentration values of estradiol obtained should be used for diagnosis in association with additional information gathered by the physician (patient questioning, current drug therapy, ultrasound scan, clinical observations, other examinations, etc).Range of expected values it is recommended that each laboratory establish its own reference interval from a rigorously selected population.The results could be impacted depending on the patient treatment.In cases of estrogen therapy, and particularly that of hormone replacement therapy (menopause), overestimated results may be obtained.Limitations of the method do not use the vidas® estradiol ii assay to measure estradiol levels in patients undergoing fulvestrant therapy.In conclusion, without all the information mentioned above, the clinical discrepancies between the both methods, ie vidas and siemens cannot be determined.Root cause analysis and conclusion according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on the retain kit vidas estradiol ii ref (b)(4) lot 1008872270 using internal samples.The vidas customer¿s results were reproduced.It was not possible to identify a potential obvious root cause.This is due to the fact: the clinical discrepancies between the both methods, ie vidas and siemens cannot be determined.There is no information regarding a detailed clinical context (cycle stage, medication).According to the investigation above vidas estradiol ii lot 1008872270 is still within expected performance.
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