Laboratory validation and field usability assessment of a point-of-care test for serum bilirubin levels in neonates in a tropical setting

Thielemans, Laurence; Hashmi, Ahmar; Priscilla, Dah Dah; Paw, Moo Kho; Pimolsorntong, Tekel; Ngerseng, Thatsanun; Overmeire, Bart Van; Proux, Stéphane; Nosten, François; McGready, Rose; Carrara, Verena I.; Bancone, Germana

doi:10.12688/wellcomeopenres.14767.2

Cited by 4 publications

(11 citation statements)

References 33 publications

(39 reference statements)

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“…The studies reported a total of 3122 paired measurements. Of the 10 included studies, 8 studied the Bilistick (Bilimetrix srl), a POC test for total bilirubin quantification in 25 μL of whole blood . The Bilistick consists of a handheld reflectance reader and test strips, which are composed of a blood-plasma filter and nitrocellulose membrane.…”

Section: Resultsmentioning

confidence: 99%

“…The reported percentage of failed quantifications of the Bilistick varied between 1.5% and 48.6% across studies, with a median of 8.75% (IQR, 5.02%-24.07%) . Common error messages were high hematocrit (>65%) and hemolysis.…”

Section: Resultsmentioning

confidence: 99%

“…After removing duplicates, titles and abstracts were screened for 879 records. Twenty-four records were selected for full-text assessment, of which 10 were included in qualitative and quantitative analyses (Figure 1).…”

Section: Resultsmentioning

confidence: 99%

“…Table 1 lists the study characteristics of the 10 included studies (representing 3122 neonates), of which 9 used a cross-sectional design and 1 a prospective cohort design; guidelines for phototherapy used by some studies are also presented. Five studies were performed in Southeast Asia, 3 in Africa, 1 in Europe and Africa, and 1 in Africa and Southeast Asia . Studies were published between 2012 and 2022.…”

Section: Resultsmentioning

confidence: 99%

“…Although viewed as the reference standard, several studies reported rather high interlaboratory variability and inaccuracy of LBB levels measured in value-assigned commutable specimens as well as in patient samples, signaling inaccuracy and imprecision . The substantial inconsistencies encountered when quantifying bilirubin on different commonly used multianalysis instruments underline the timelessness of Mather’s statement that “bilirubin determinations are perhaps the most notoriously unreliable of any in clinical chemistry.” (p350) The inaccuracy and high variability of POC bilirubin test results may, at least in part, originate from hemolysis or be affected by the relatively high hemoglobin concentration in the newborn . To this end, the Bilistick displays a warning message in case of too much hemolysis.…”

Section: Discussionmentioning

confidence: 99%

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Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates

et al. 2023

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ImportanceQuantification of bilirubin in blood is essential for early diagnosis and timely treatment of neonatal hyperbilirubinemia. Handheld point-of-care (POC) devices may overcome the current issues with conventional laboratory-based bilirubin (LBB) quantification.ObjectiveTo systematically evaluate the reported diagnostic accuracy of POC devices compared with LBB quantification.Data SourcesA systematic literature search was conducted in 6 electronic databases (Ovid MEDLINE, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, CINAHL, and Google Scholar) up to December 5, 2022.Study SelectionStudies were included in this systematic review and meta-analysis if they had a prospective cohort, retrospective cohort, or cross-sectional design and reported on the comparison between POC device(s) and LBB quantification in neonates aged 0 to 28 days. Point-of-care devices needed the following characteristics: portable, handheld, and able to provide a result within 30 minutes. This study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline.Data Extraction and SynthesisData extraction was performed by 2 independent reviewers into a prespecified, customized form. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Meta-analysis was performed of multiple Bland-Altman studies using the Tipton and Shuster method for the main outcome.Main Outcomes and MeasuresThe main outcome was mean difference and limits of agreement in bilirubin levels between POC device and LBB quantification. Secondary outcomes were (1) turnaround time (TAT), (2) blood volumes, and (3) percentage of failed quantifications.ResultsTen studies met the inclusion criteria (9 cross-sectional studies and 1 prospective cohort study), representing 3122 neonates. Three studies were considered to have a high risk of bias. The Bilistick was evaluated as the index test in 8 studies and the BiliSpec in 2. A total of 3122 paired measurements showed a pooled mean difference in total bilirubin levels of −14 μmol/L, with pooled 95% CBs of −106 to 78 μmol/L. For the Bilistick, the pooled mean difference was −17 μmol/L (95% CBs, −114 to 80 μmol/L). Point-of-care devices were faster in returning results compared with LBB quantification, whereas blood volume needed was less. The Bilistick was more likely to have a failed quantification compared with LBB.Conclusions and RelevanceDespite the advantages that handheld POC devices offer, these findings suggest that the imprecision for measurement of neonatal bilirubin needs improvement to tailor neonatal jaundice management.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates

et al. 2023

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Diagnostic Properties of a Portable Point-of-Care Method to Measure Bilirubin and a Transcutaneous Bilirubinometer

et al. 2021

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Background: Recently, the Bilistick®, a point-of-care instrument to measure bilirubin levels, has been developed. It is fast and cheaper than transcutaneous bilirubin (TCB)-measuring devices, but data on diagnostic properties are scarce. Objective: This study aimed to compare the performance of the Bilistick® (BM-BS 1.0 – FW version 2.0.1) and the JM-105 bilirubinometer for measuring bilirubin. Method: This is a prospective study in infants born after ≥32 weeks’ gestation, and/or a birth weight of ≥1,500 g, and a postnatal age ≤14 days in Surabaya, Indonesia. Bilirubin was measured with the Bilistick® System (BM-BS 1.0 – FW version 2.0.1), transcutaneously (TCB) with the JM-105 bilirubinometer, and in serum (TSB) with a routine laboratory technique. Mean differences and 95% limits of agreement (LOA) and correlations were calculated. Result: We enrolled 149 neonates and 126 had paired measurements of Bilistick® bilirubin, TCB, and TSB. Bilistick® failed in 16 (10.7%) infants. Mean Bilistick® bilirubin-TSB difference was −11 µmol/L (95% LOA: −101 to 79 µmol/L) and r = 0.738 (p < 0.001). Mean TCB-TSB difference was 26 μmol/L (95% LOA: −33 to 88) and r = 0.785 (p < 0.001). The sensitivity, specificity, PPV, and NPV for Bilistick® bilirubin for a TSB above treatment thresholds were 0.74, 0.84, 0.67, and 0.88, respectively, and for TCB 0.92, 0.64, 0.54, and 0.95, respectively. Conclusion: The Bilistick® System (BM-BS 1.0 – FW version 2.0.1) underestimates TSB, whereas TCB overestimates TSB in jaundiced Indonesian infants. Further improvement of Bilistick®’s diagnostic accuracy with less false-negative readings is essential to increase its use.

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Design and field evaluation of a lateral flow cassette device for point-of-care bilirubin measurement

Shapiro,

Mtenthaonga,

Mjumira

et al. 2023

PLOS Glob Public Health

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Neonatal jaundice is an important cause of morbidity and mortality worldwide, and neonates born in low and middle-income countries bear a disproportionate burden. We previously developed a low-cost, point-of-care system to measure total serum bilirubin (TSB) in neonates. This device was effective at detecting and monitoring jaundice; however, the disposable strips were difficult to produce at scale. Here, we report a new lateral flow cassette design, called BiliDx, that was produced at scale using traditional manufacturing techniques. We evaluated the performance of BiliDx at sites in Nigeria and Malawi. The lateral flow strip consists of plasma separation membranes, nitrocellulose, and a plastic cassette. We evaluated the performance of the strips and reader at two hospitals located in Nigeria and Malawi compared to reference standard TSB. We also assessed performance for samples with high direct bilirubin (DB) and high hematocrit (HCT). We collected 1,144 samples from 758 neonates (TSB ranged from 0.2 to 45.9 mg/dL). The mean bias of BiliDx measurements in the validation set was +0.75 mg/dL, and 95% limits of agreement were -2.57 to 4.07 mg/dL. The mean bias and limits of agreement were comparable for samples with HCT < 60% and HCT ≥ 60%, and for samples with low and intermediate DB levels; the samples with high DB levels had wider 95% limits of agreement (-4.50 to +3.03 mg/dL). Error grid analysis shows that 96.9% of samples measured with BiliDx would have resulted in the same clinical decision as the reference standard. This performance is comparable to previous results that used a handmade two-dimensional strip. Additionally, error grid analysis shows that all 20 samples with high DB levels would have resulted in the same clinical decision as the reference standard. This evaluation supports the use of BiliDx lateral flow cassettes to provide accurate point-of-care measurements in low-resource settings.

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Laboratory validation and field usability assessment of a point-of-care test for serum bilirubin levels in neonates in a tropical setting

Cited by 4 publications

References 33 publications

Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates

Diagnostic Accuracy of Portable, Handheld Point-of-Care Tests vs Laboratory-Based Bilirubin Quantification in Neonates

Diagnostic Properties of a Portable Point-of-Care Method to Measure Bilirubin and a Transcutaneous Bilirubinometer

Design and field evaluation of a lateral flow cassette device for point-of-care bilirubin measurement

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