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Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India.

Abstract

OBJECTIVES

Sickle cell anemia is the commonest genetic disorder in India, and the frequency of the sickle cell gene is very high in the remote tribal areas where facilities are generally limited. Therefore, a rapid and affordable point-of-care test for sickle cell disease is needed.

METHODS

The diagnostic accuracy of HemoTypeSC was evaluated against automated high-performance liquid chromatography (HPLC) as the gold standard for its efficacy in a newborn screening program.

RESULTS

A total of 1,559 individuals (980 newborns and 579 adults) from four participating centers were analyzed by both methods. HemoTypeSC correctly identified 209 of 211 total hemoglobin (Hb) SS cases, for a 99.1%/99.9% total HbSS sensitivity/specificity. Overall, HemoTypeSC exhibited sensitivity and specificity of 98.1% and 99.1% for all possible phenotypes (HbAA, HbAS, and HbSS) detected. HPLC is relatively expensive and not available in most laboratories in remote tribal areas.

CONCLUSIONS

We conclude that the rapid, point-of-care testing device HemoTypeSC test is suitable for population and newborn screening for the HbS phenotype.

Authors+Show Affiliations

ICMR-National Institute of Immunohaematology, Maharashtra, India. Haemoglobinopathies Satellite Center (ICMR-NIIH), Maharashtra, India.ICMR-National Institute of Immunohaematology, Maharashtra, India.ICMR-National Institute of Immunohaematology, Maharashtra, India.Haemoglobinopathies Satellite Center (ICMR-NIIH), Maharashtra, India.Indira Gandhi Government Medical College, Maharashtra, India.SEWA Rural, Gujarat, India.SEWA Rural, Gujarat, India.Valasad Raktadan Kendra, Gujarat, India.Valasad Raktadan Kendra, Gujarat, India.Silver Lake Research Corporation, Azusa, CA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31433854

Citation

Mukherjee, Malay B., et al. "Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India." American Journal of Clinical Pathology, 2019.
Mukherjee MB, Colah RB, Mehta PR, et al. Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India. Am J Clin Pathol. 2019.
Mukherjee, M. B., Colah, R. B., Mehta, P. R., Shinde, N., Jain, D., Desai, S., ... Serrao, E. (2019). Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India. American Journal of Clinical Pathology, doi:10.1093/ajcp/aqz108.
Mukherjee MB, et al. Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India. Am J Clin Pathol. 2019 Aug 1; PubMed PMID: 31433854.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease Rapid Diagnostic Test for Newborns and Adults Across India. AU - Mukherjee,Malay B, AU - Colah,Roshan B, AU - Mehta,Pallavi R, AU - Shinde,Nikhil, AU - Jain,Dipty, AU - Desai,Shrey, AU - Dave,Kapilkumar, AU - Italia,Yazdi, AU - Raicha,Bhavesh, AU - Serrao,Erik, Y1 - 2019/08/01/ PY - 2019/8/22/entrez KW - HemoTypeSC KW - India KW - Newborn KW - Point of care KW - Sickle cell disease JF - American journal of clinical pathology JO - Am. J. Clin. Pathol. N2 - OBJECTIVES: Sickle cell anemia is the commonest genetic disorder in India, and the frequency of the sickle cell gene is very high in the remote tribal areas where facilities are generally limited. Therefore, a rapid and affordable point-of-care test for sickle cell disease is needed. METHODS: The diagnostic accuracy of HemoTypeSC was evaluated against automated high-performance liquid chromatography (HPLC) as the gold standard for its efficacy in a newborn screening program. RESULTS: A total of 1,559 individuals (980 newborns and 579 adults) from four participating centers were analyzed by both methods. HemoTypeSC correctly identified 209 of 211 total hemoglobin (Hb) SS cases, for a 99.1%/99.9% total HbSS sensitivity/specificity. Overall, HemoTypeSC exhibited sensitivity and specificity of 98.1% and 99.1% for all possible phenotypes (HbAA, HbAS, and HbSS) detected. HPLC is relatively expensive and not available in most laboratories in remote tribal areas. CONCLUSIONS: We conclude that the rapid, point-of-care testing device HemoTypeSC test is suitable for population and newborn screening for the HbS phenotype. SN - 1943-7722 UR - https://www.unboundmedicine.com/medline/citation/31433854/Multicenter_Evaluation_of_HemoTypeSC_as_a_Point-of-Care_Sickle_Cell_Disease_Rapid_Diagnostic_Test_for_Newborns_and_Adults_Across_India L2 - https://academic.oup.com/ajcp/article-lookup/doi/10.1093/ajcp/aqz108 DB - PRIME DP - Unbound Medicine ER -