PMID- 31433854

OWN - NLM
STAT- Publisher
LR - 20190821
IS - 1943-7722 (Electronic)
IS - 0002-9173 (Linking)
DP - 2019 Aug 1
TI - Multicenter Evaluation of HemoTypeSC as a Point-of-Care Sickle Cell Disease
Rapid
Diagnostic Test for Newborns and Adults Across India.
LID - aqz108 [pii]
LID - 10.1093/ajcp/aqz108 [doi]
AB - 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.
CI - (c) American Society for Clinical Pathology, 2019. All rights reserved. For
permissions, please e-mail: journals.permissions@oup.com.
FAU - Mukherjee, Malay B
AU - Mukherjee MB
AD - ICMR-National Institute of Immunohaematology, Maharashtra, India.
AD - Haemoglobinopathies Satellite Center (ICMR-NIIH), Maharashtra, India.
FAU - Colah, Roshan B
AU - Colah RB
AD - ICMR-National Institute of Immunohaematology, Maharashtra, India.
FAU - Mehta, Pallavi R
AU - Mehta PR
AD - ICMR-National Institute of Immunohaematology, Maharashtra, India.
FAU - Shinde, Nikhil
AU - Shinde N
AD - Haemoglobinopathies Satellite Center (ICMR-NIIH), Maharashtra, India.
FAU - Jain, Dipty
AU - Jain D
AD - Indira Gandhi Government Medical College, Maharashtra, India.
FAU - Desai, Shrey
AU - Desai S
AD - SEWA Rural, Gujarat, India.
FAU - Dave, Kapilkumar
AU - Dave K
AD - SEWA Rural, Gujarat, India.
FAU - Italia, Yazdi
AU - Italia Y
AD - Valasad Raktadan Kendra, Gujarat, India.
FAU - Raicha, Bhavesh
AU - Raicha B
AD - Valasad Raktadan Kendra, Gujarat, India.
FAU - Serrao, Erik
AU - Serrao E
AD - Silver Lake Research Corporation, Azusa, CA.
LA - eng
PT - Journal Article
DEP - 20190801
PL - England
TA - Am J Clin Pathol
JT - American journal of clinical pathology
JID - 0370470
SB - AIM
SB - IM
OTO - NOTNLM
OT - HemoTypeSC
OT - India
OT - Newborn
OT - Point of care
OT - Sickle cell disease
EDAT- 2019/08/23 06:00
MHDA- 2019/08/23 06:00
CRDT- 2019/08/22 06:00
PHST- 2019/08/22 06:00 [entrez]
PHST- 2019/08/23 06:00 [pubmed]
PHST- 2019/08/23 06:00 [medline]
AID - 5552705 [pii]
AID - 10.1093/ajcp/aqz108 [doi]
PST - aheadofprint
SO - Am J Clin Pathol. 2019 Aug 1. pii: 5552705. doi: 10.1093/ajcp/aqz108.