Paradoxical behaviour of lyophilised commercial control materials for CK and CK-MB assays after reconstitution at either 4°C or 24°C

Lippi, Giuseppe; Brentegani, Claudio; Cocco, Claudio; Cascio, Claudia Lo; Guidi, Gian Cesare

doi:10.1016/s0009-8981(97)06522-4

Clinica Chimica Acta

1997

DOI: 10.1016/s0009-8981(97)06522-4

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Paradoxical behaviour of lyophilised commercial control materials for CK and CK-MB assays after reconstitution at either 4°C or 24°C

Giuseppe Lippi

Claudio Brentegani

Claudio Cocco

et al.

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Cited by 3 publications

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“…& Different interpretations of positivity for mixing studies (e.g., Rosner index, percent corrections, correction into the normal range) requires reconstitution before use. Use of incorrect diluents, insufficient reconstitution volume, or inadequate adherence to manufacturer's recommendations may result in incorrect control values 21. Aside from commercially supplied QC material, it has been suggested that an additional level of QC for LA testing can be obtained by pooling the plasma from known positive LA samples, and then freezing in aliquots before future use 22.…”

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confidence: 99%

Measurement of Lupus Anticoagulants: An Update on Quality in Laboratory Testing

Adams

2013

Semin Thromb Hemost

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Lupus anticoagulants (LAs) are antiphospholipid antibodies that interfere with in vitro phospholipid-dependent clotting tests, but are associated in vivo with significant clinical manifestations such as recurrent pregnancy loss and venous and arterial thrombosis. Although their detection is important for the diagnosis of thrombotic disorders such as the antiphospholipid syndrome, laboratory identification has historically been fraught with many issues. These have included variability in the sensitivity of assays and reagents; high false-negative and false-positive detection rates; a lack of consensus for the use of mixing tests; and, to some extent, lack of compliance with guidelines published by the Lupus Anticoagulant/Antiphospholipid Antibody Scientific Standardization Committee of the International Society on Thrombosis and Haemostasis (ISTH). Since the most recently updated guidelines in 2009, external quality assurance (EQA) programs have conducted surveys to provide a "snapshot" of laboratory practices related to the investigation of LA and to identify problems and monitor improvements in testing for LA. This article will review the impact of the most recently updated ISTH guidelines for LA testing and discuss the findings of recent EQA surveys.

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confidence: 99%

Measurement of Lupus Anticoagulants: An Update on Quality in Laboratory Testing

Adams

2013

Semin Thromb Hemost

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Estimating the intra- and inter-individual imprecision of manual pipetting

Lippi

Lima-Oliveira

Brocco

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Impact of water temperature on reconstitution of quality controls for routine hemostasis testing

et al. 2020

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BackgroundThis study aimed to investigate whether the temperature of distilled water used for reconstituting lyophilized routine internal quality control (IQC) material may influence the process of validation of analytical sessions of routine hemostasis testing.MethodsRoutine hemostasis testing was performed for 10 consecutive days using two levels of IQC materials dissolved using distilled water at three different temperatures (2–4°C, 22–24°C and 36–38°C). The tests assayed comprised prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FBG), antithrombin (AT), protein C (PC), protein S (PS) and D-dimer (D-Dimer HS 500), using the same ACL TOP 700 hemostasis instrument.ResultsOverall, 50% (i.e. 7/14) IQC measurements displayed statistically significant bias when lyophilized material was dissolved with distilled water at 3–5°C compared to 22–24°C, and in two instances (level I for both PT and D-dimer) the bias was higher than the quality specifications. Concerning lyophilized material dissolved with distilled water at 36–38°C, 21% (3/14) IQC values displayed a statistically significant bias compared to 22–24°C, and in one instance (level 2 for PT) the bias was higher than the quality specifications.ConclusionsThe results of this study show that water temperature, as used to dissolve lyophilized IQC material, may represent an important pre-analytical variable in routine hemostasis testing, especially cold temperatures. Laboratory professionals are encouraged to standardize water temperature, preferably between 22 and 24°C, before reconstituting lyophilized IQC materials used to validate routine hemostasis testing.

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Paradoxical behaviour of lyophilised commercial control materials for CK and CK-MB assays after reconstitution at either 4°C or 24°C

Cited by 3 publications

References 11 publications

Measurement of Lupus Anticoagulants: An Update on Quality in Laboratory Testing

Measurement of Lupus Anticoagulants: An Update on Quality in Laboratory Testing

Estimating the intra- and inter-individual imprecision of manual pipetting

Impact of water temperature on reconstitution of quality controls for routine hemostasis testing

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