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HemoTypeSC™

HemoTypeSC™ is a rapid test kit for the determination of haemoglobin type in whole blood. This is a competitive lateral flow assay incorporating monoclonal antibodies for detection of haemoglobin A, haemoglobin S, and haemoglobin C.

HemoTypeSC™ provides point-of-care determination of haemoglobin phenotypes HbAA (normal), HbSS and HbSC (sickle cell disease), HbCC (haemoglobin C disease), and HbAS and HbAC (carrier or trait). HemoTypeSC™ does not detect other haemoglobin variants (such as Hb D or E) – these variants will give the same result as Hb A.

HemoTypeSC™ does not detect – and results are not affected by – fetal haemoglobin, and is therefore suitable for newborn screening.

Sickle cell disease (SCD) is a genetic condition that is present at birth. It is inherited when a child receives two sickle cell genes – one from each parent.

1 Steele et al.: Am J Hematol. 2018 Oct 5. doi: 10.1002/ajh.25305.
2 Quinn et al.: Br J Hematol. 2016 Nov; 175(4):724-73
Technical specifications
Intended use

HemoTypeSCTM is a rapid test kit for the determination of haemoglobin (Hb) type in whole blood

Assay principle 

Competitive lateral flow assay

Antibody type

Monoclonal

Sample preparation

Whole blood

Sample type

EDTA, finger prick. heel stick, dried blood spots

Sample volume

1.5ul

Storage & stability

Unopened: 15-40oC for 2 years

Opened: 30 days

Type of result

Qualitative

Separate Liquid Buffer

Required

No

Limit of Detection for

Haemoglobins A, S, and C

<2%, <2%, & <2%, respectively.

Time to result

5-10 minutes

Interference by fetal haemoglobin

No

Suitable for newborn screening

Yes

Test procedure

2-step procedure 

Requirement for an instrument

No

Sensitivity (for all phenotypes)

≥98% in field conditions2,3,4

Specificity

≥98% in field conditions2,3,4

Overall diagnostic accuracy

>98% in field conditions3

Internal controls

Internal control

Pack size

50 tests including 50 blood sampling devices and 3 dropper pipettes

3 Mukherjee M, Colah R et al. Multicentre Evaluation of HemoTypeSC as  a Point-of-Care Sickle Cell Disease Rapid Diagnostic test or New-borns and  Adults Across India. Am J Clin Pathol. 2019; 1-6.
4 Nakanja R et al. HemoTypeSC demonstrated >99% field accuracy in a sickle cell disease screening initiative in children of south-eastern Uganda. Am J Hematol. 2019; 1-3
Contact

Sysmex Europe GmbH

Bornbarch 1

22848 Norderstedt

Germany

+49 (40) 527 26 0

+49 (40) 527 26 100

Training

Access the training course "HemoTypeSC™ – A Rapid Point-of-Care Test for Haemoglobins That Cause Sickle Cell Disease" on the Sysmex Academy portal here.

Documents

Product documents

Regulatory Documents

Regulatory documents, such as Instructions for Use, can be accessed with a valid My Sysmex login:

Go to My Sysmex

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