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Ann Biol Clin (Paris). 2018 Aug 1;76(4):416-420. doi: 10.1684/abc.2018.1354.

Sickle SCAN™ (BioMedomics) fulfills analytical conditions for neonatal screening of sickle cell disease.

Author information

1
Service de biochimie générale, Hôpital universitaire Necker-Enfants malades, AP-HP, Paris, France.
2
Unité de dépistage néonatal de la drépanocytose et des hémoglobinopathies, Laboratoire de biochimie hormonologie, Hôpital Robert Debré, AP-HP, Paris, France.
3
Département de biothérapie, Hôpital universitaire Necker-Enfants malades, AP-HP, Paris, France.
4
Département de biothérapie, Hôpital universitaire Necker-Enfants malades, AP-HP, Paris, France, Centre d'investigation clinique, Hôpitaux universitaires Paris-Ouest, AP-HP, Inserm, Paris, France.
5
Fédération parisienne pour le dépistage et la prévention des handicaps de l'enfant, Hôpital universitaire Necker-Enfants malades, AP-HP, Paris, France.
6
BioMedomics Inc., Durham, North Carolina, USA.
7
Eurocord/Monacord, Hôpital Saint-Louis, AP-HP, Paris et Centre scientifique de Monaco, Monaco, France.
8
Département de génétique, Institute Imagine, Paris, France.

Abstract

Sickle SCAN™ is a rapid, qualitative, point-of-care lateral flow immunoassay for the identification of AS, AC, SS/Sβ0thal, SC and CC/Cβ0thal phenotype. We evaluated this test under the conditions encountered in the French newborn screening (NBS) program for sickle cell disease: a total of 104 dried blood spots (DBSs) were tested with an HPLC reference method and then with the Sickle SCAN™ device. Sickle SCAN™ identified the hemoglobin (Hb) phenotype correctly on 96% of cases. In the four non-concordant cases, the antibody anti-HbS cross-reacted with HbE (n=2), HbD (n=1) or HbX (n=1). There were no false negative. In order to test Sickle SCAN™'s sensitivity to low levels of HbA and HbS in the presence of high HbF levels, we selected another 21 DBS cards with low percentages of HbA (0.6-4.2%) and HbS (2.0-6.9%). HbA and HbS were always detected when present at levels of more than 1% and 2%, respectively. Sickle SCAN™ appears to be an accurate point-of-care method for the identification of newborns with SCD trait. The device meets the criteria for sickle cell disease NBS programs in endemic countries with poor access to laboratory equipment.

KEYWORDS:

hemoglobin S; newborn screening; point-of-care; sickle cell disease

PMID:
29976532
DOI:
10.1684/abc.2018.1354
[Indexed for MEDLINE]

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