Influence of Practicable Virus Inactivation Procedures on Tests for Frequently Measured Analytes in Plasma

Hersberger, Martin; Nusbaumer, Charly; Scholer, André; Knöpfli, Verena; Eckardstein, Arnold von

doi:10.1373/clinchem.2004.031666

Cited by 21 publications

(18 citation statements)

References 6 publications

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“…In another study of plasma analytes, heat inactivation decreased the measured concentrations of analytes to 70 to 80% of the noninactivated controls, whereas Triton X-100 had a minimal effect, with concentrations of 91 to 107% of the controls (11). These data support our finding that P. falciparum nucleic acid copy number varied similarly with inactivation procedures.…”

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confidence: 83%

“…The available data on the effects of filoviral inactivation procedures on the performance characteristics of malaria diagnostic assays are limited and variable (10,11). We sought to evaluate the performance characteristics of both RDT and quantitative realtime PCR for detecting P. falciparum malaria following Triton X-100 and heat inactivation compared to those using the standard operating procedure.…”

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confidence: 99%

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Evaluation of Ebola Virus Inactivation Procedures for Plasmodium falciparum Malaria Diagnostics

et al. 2015

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c Plasmodium falciparum malaria is highly endemic in the three most affected countries in the current epidemic of Ebola virus disease (EVD) in West Africa. As EVD and malaria are clinically indistinguishable, both remain part of the differential diagnosis of ill travelers from returning from areas of EVD transmission. We compared the performances of a rapid diagnostic test (Binax-NOW) and real-time PCR with P. falciparum-positive specimens before and after heat and Triton X-100 inactivation, and we documented no loss of sensitivity.T he current outbreak of Ebola virus disease (EVD) in West Africa is the largest on record (1), and guidance has emerged in hospital and outpatient settings around screening for EVD in ill travelers who have returned from areas of EVD transmission (2, 3). Plasmodium falciparum malaria is highly endemic in the three most affected countries, Sierra Leone, Liberia, and Guinea, which contribute Ͼ3 million cases annually to the global burden of malaria (4). Malaria can cause severe morbidity and mortality if diagnosis and/or treatment are delayed (5); yet, hospital laboratories are often ill-prepared to handle specimens from an individual suspected to have a filoviral infection (6). Laboratory safety must be balanced against the timely exclusion of malaria in ill travelers who have returned from EVD-affected regions in order to avoid adverse outcomes in patients. The Centers for Disease Control and Prevention (CDC) has recommended the addition of Triton X-100 and heat inactivation at 56°C prior to testing specimens from patients suspected to have filoviral infection, in addition to performing enhanced safety procedures, such as using personal protective equipment (PPE) and a certified class II biosafety cabinet (BSC) (7,8). The inactivation of blood prior to the preparation of malaria thin smears is unnecessary, as filoviruses are inherently susceptible to methanol (7, 9), the solvent in which malaria thin smears are fixed prior to staining. However, rapid diagnostic tests (RDT) for malaria are widely and routinely used in hematology and microbiology laboratories and have no corresponding fixation step. Similarly, the extraction of nucleic acid for molecular diagnostic assays is presumed to inactivate filoviruses, although data on this are lacking.The available data on the effects of filoviral inactivation procedures on the performance characteristics of malaria diagnostic assays are limited and variable (10, 11). We sought to evaluate the performance characteristics of both RDT and quantitative realtime PCR for detecting P. falciparum malaria following Triton X-100 and heat inactivation compared to those using the standard operating procedure. We documented no loss of sensitivity for either assay when performing filoviral inactivation procedures.Thirty-one P. falciparum-containing whole blood EDTA specimens, with parasitemia levels ranging from Ͻ0.1% to 6.6% and confirmed by microscopy and RDT (BinaxNOW Malaria, Alere, ME), were included, along with 10 negative-control EDTA specimens. Nin...

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Evaluation of Ebola Virus Inactivation Procedures for Plasmodium falciparum Malaria Diagnostics

et al. 2015

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“…Hersberger [19] described the influence of Triton X-100 on several clinical chemistry and coagulation tests. The addition of 0.1% Triton X-100 practically did not interfere with the test results obtained on the untreated samples for clinical chemistry parameters.…”

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Diagnostic performances of clinical laboratory tests using Triton X-100 to reduce the biohazard associated with routine testing of Ebola virus-infected patients

Tempestilli

Pucci

Notari

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…13 However, the report only stated the change in percentage, with no information provided for diagnostic utility (eg the correlation of the post-heat inactivation procedure result with the result obtained without the inactivation procedure, which would indicate retention of diagnostic information). 13,14 Therefore, this study aimed to provide a statistical delineation of the heat inactivation procedure effects on more common general chemistry analytes using the AU5822 (Beckman Coulter Inc, Pasadena [CA], US) and troponin I using the Access 2 Immunoassay System (Beckman Coulter Inc).…”

Section: Implications For Clinical Practice or Policymentioning

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Effects of a plasma heating procedure for inactivating Ebola virus on common chemical pathology tests

chong¹,

Ng²,

Chen³

et al. 2015

Hong Kong Med J

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Objectives:The recent declaration of Ebola virus disease as epidemic by the World Health Organization indicates urgency for affected countries and their laboratories to evaluate and provide treatment to patients potentially infected by the Ebola virus. A heat inactivation procedure involving treating specimens at 60°C for 60 minutes has been suggested for inactivation of the Ebola virus. This study aimed at evaluating the effect of plasma heating on common biochemical tests. Design: Comparative experimental study.Setting: A regional chemical pathology laboratory in Hong Kong.Methods: Forty consecutive plasma specimens for general chemistry analytes on Beckman Coulter AU5822 and another 40 plasma specimens for troponin I analysis on Access 2 Immunoassay System were obtained, anonymised, and divided into two aliquots. One aliquot was analysed directly and the other was analysed after heating at 60°C for 60 minutes.Results: A total of 20 chemical pathology tests were evaluated. Nine tests (sodium, potassium, chloride, urea, creatinine, total calcium, phosphate, total protein, and glucose) were not significantly affected by the heat inactivation procedure and remained clinically interpretable. Results for magnesium (15% mean increase), albumin (41% mean increase), bilirubin (8% mean decrease), amylase (27% mean decrease), and troponin I (76% mean decrease) were still interpretable using regression estimation with Effects of a plasma heating procedure for inactivating Ebola virus on common chemical pathology testsNew knowledge added by this study • Heat inactivation results in no significant change in electrolytes, glucose, and renal function tests, but causes a significant bias for many analytes in routine biochemistry tests. Implications for clinical practice or policy• For the analytical methodologies tested, nine tests (sodium, potassium, chloride, urea, creatinine, total calcium, phosphate, total protein, and glucose) were not significantly affected.• Magnesium, albumin, bilirubin, amylase, and troponin I were still interpretable using regression estimation with a linear proportional bias.• However, alanine transaminase, aspartate transaminase, alkaline phosphatase, gamma-glutamyltransferase, creatine kinase, and lactate dehydrogenase were inactivated to a significant degree with rejected normality and are not useful clinically.• When a patient suspected of having Ebola virus disease cannot be managed in a facility with comprehensive containment facilities, a heat inactivation procedure can be applied to allow analysis of the specimens with acceptable risk, when used in concert with appropriate precautions, and still yield some clinically useful results.

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Influence of Practicable Virus Inactivation Procedures on Tests for Frequently Measured Analytes in Plasma

Cited by 21 publications

References 6 publications

Evaluation of Ebola Virus Inactivation Procedures for Plasmodium falciparum Malaria Diagnostics

Evaluation of Ebola Virus Inactivation Procedures for Plasmodium falciparum Malaria Diagnostics

Diagnostic performances of clinical laboratory tests using Triton X-100 to reduce the biohazard associated with routine testing of Ebola virus-infected patients

Effects of a plasma heating procedure for inactivating Ebola virus on common chemical pathology tests

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