Evaluation of an immunochromatographic strip test for alpha‐thalassaemia screening

Bunkall, Carolyn; Ghallyan, Nikhil; Elliott, Catherine; Water, Neil Van de; Chan, George

doi:10.1111/ijlh.12905

Cited by 6 publications

(13 citation statements)

References 12 publications

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“…Regarding sample stability, our results are in agreement with Bunkall et al who demonstrated that there was no difference between ICT results at 24 hours and 7 days. The age of the false‐positive results was not statistically different to that of the true negatives, suggesting that false positives cannot be attributed to sample age.…”

Section: Discussionsupporting

confidence: 93%

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Evaluation of an immunochromatographic test for alpha thalassaemia screening in a multi‐ethnic population

Nelson

Motum

Emeto

2019

Int J Lab Hematology

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Introduction The standard screening method for alpha thalassaemia is the examination of HbH preparation. It is labour intensive and poorly standardized. The development of a rapid strip immunochromatographic test (ICT) for haemoglobin Barts offers a fast, user friendly and cost‐effective alternative screening tool. Method A total of 180 subjects with results of the thalassaemia screen and genetic testing were included. Results of the ICT and HbH preparation were correlated with genetic results to determine the performance characteristics of the tests and the effect of mean sample age on results. Results Of 180 subjects, 111 carried alpha thalassaemia mutations and 69 participants had normal genetic results. The ICT had a sensitivity of 63.06% for all alpha gene mutations and 100% for both heterozygous alpha0 and HbH disease, with a specificity of 91.30%. Examination of HbH preparation had a sensitivity of 34.23% overall, detecting 89% of heterozygous alpha0 and 100% of HbH disease with a specificity of 98.55%. Sample age did not affect overall results. Conclusions The ICT is a sensitive screening method for significant alpha mutations and detects the majority of homozygous alpha+ and nondeletional mutations. It demonstrates greater correlation with genetic testing than HbH preparation and could replace HbH preparation in the screening algorithm for alpha thalassaemia.

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Section: Discussionsupporting

confidence: 93%

“…Limitations of the ICT include the potential for false‐positive results with elevated HbF and in neonates. Bunkall et al demonstrated that it could be used from 6 months of age, but until this time genetic studies would be required to diagnose an alpha gene abnormality.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of an immunochromatographic test for alpha thalassaemia screening in a multi‐ethnic population

Nelson

Motum

Emeto

2019

Int J Lab Hematology

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“…However, using the i+LAB α THAL IC strip test, 3 α 0 -thalassemia (-- SEA ) samples showed a negative result. As Hb Bart’s has also been demonstrated as a marker for α 0 -thalassemia traits [21, 25–27], the negative samples in this study may be false negatives. It is worth noting that these 3 samples showed a very faint band in the T line zone but were designed as negative.…”

Section: Discussionmentioning

confidence: 87%

“…In this study, the IC ζ strip test for detecting ζ-globin chains was validated in parallel with the commercialized IC strip test for detecting Hb Bart’s (i+LAB α THAL IC strip test [21, 25–27].…”

Section: Resultsmentioning

confidence: 99%

“…The minute amounts of Hb Bart’s and ζ-globin chains in red blood cells (RBCs) are especially observable in α 0 -thalassemia subjects, including those with α 0 -thalassemia (-- SEA ) [19–24]. Using a monoclonal antibody (mAb) generated in our lab, we previously developed an immunochromatographic (IC) strip test for detecting Hb Bart’s in RBC hemolysates [21, 25–27]. In this study, using a panel of our generated anti-ζ-globin chain mAbs [28], we established another IC strip test that can detect ζ-globin chains in RBC lysates.…”

Section: Introductionmentioning

confidence: 99%

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Impact of the detection of ζ-globin chains and hemoglobin Bart’s using immunochromatographic strip tests for α0-thalassemia (--SEA) differential diagnosis

et al. 2019

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α0-Thalassemia is an inherited hematological disorder caused by the deletion of α-globin genes. The Southeast Asian deletion (--SEA) is the most common type of α0-thalassemia observed in Southeast Asian countries. Regarding WHO health policy, an effective α0-thalassemia screening strategy is needed to control new severe α-thalassemia cases. In this study, a monoclonal antibody panel was used to develop immunochromatographic (IC) strip tests for detecting the Hb Bart’s and ζ-globin chain. Among 195 samples, all α0-thalassemia traits (78 α0-thalassemia (--SEA) and 4 α0-thalassemia (--THAI)) had low MCV or MCH values. The sensitivity, specificity, PPV and NPV of the IC strip tests for ζ-globin and Hb Bart’s for screening α0-thalassemia (--SEA) within the low MCV or MCH samples were 100%, 65.2%, 90.7%, 100% and 96.2%, 47.8%, 86.6%, 78.6%, respectively. All 4 α0-thalassemia (--THAI) traits were negative for ζ-globin chains but positive for Hb Bart’s using the IC strip tests. These results led to a α0-thalassemia screening being proposed in which blood samples are first evaluated by MCV, MCH and Hb typing. Samples with high MCV and MCH values are excluded for the presence of the α0-thalassemia gene. Samples with low MCV or MCH values are assayed using the developed IC strip tests, where only samples testing positive are further assayed for α0-thalassemia by PCR. Patients with Hb H, EA Bart’s or EF Bart’s diseases do not need to use this IC strip assay. Thus, in this study, a simple and cost effective α0-thalassemia point of care test was developed.

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α, β, δ and γ thalassaemias and related conditions

2020

Haemoglobinopathy Diagnosis

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Evaluation of an immunochromatographic strip test for alpha‐thalassaemia screening

Abstract: The ICT is simple to perform, with higher sensitivity than HbH-i, and gives the result in a short time and at a lower cost. This can be used by clinical laboratories to replace HbH-i for α-thalassaemia detection.

Cited by 6 publications

References 12 publications

Evaluation of an immunochromatographic test for alpha thalassaemia screening in a multi‐ethnic population

Evaluation of an immunochromatographic test for alpha thalassaemia screening in a multi‐ethnic population

Impact of the detection of ζ-globin chains and hemoglobin Bart’s using immunochromatographic strip tests for α0-thalassemia (--SEA) differential diagnosis

α, β, δ and γ thalassaemias and related conditions

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