The Scientist Names PreciseType Among the Top 10 Innovations in 2014. Click here to read The Scientist article.

Finding Better Matched Blood for Patients            Click here to read the Wall Street Journal article.

The first and only FDA-approved in-vitro diagnostic (IVD) for molecular typing of red blood cell antigens

PreciseType™ HEA test is a multiplexed molecular assay that generates detailed molecular information from patient and donor samples, rapidly detecting genotypes for accurate prediction of phenotypes:

• Tests for a wide range of genetic variants affecting red blood cell antigen expression¹
  • Automated array imaging
  • Computerized data management
• Identifies the most relevant 35 red blood cell antigens from 11 blood groups

• Detects 24 gene mutations and one polymorphism associated with hemoglobinopathies (Sickle-cell Hemoglobin is not intended for the diagnosis of sickle cell disease)

Test of Record—no confirmation with antisera required

PreciseType^TM HEA Test results require no confirmation with antisera—which may save time and reduce costs compared with experimental products that have not been FDA approved such as Research Use Only (RUO) molecular tests.

Highly repeatable and reproducible results

PreciseType^TM HEA test provides clinicians with an exceptional new tool to assist in determining donor-patient compatibility. In a multi-site, multi-operator study assessing reproducibility and repeatability using a fully characterized panel of 11 human genomic DNA samples tested over five (5) days, PreciseType^TM results were 100% repeatable and reproducible.¹

With a high level of reliability, PreciseType^TM HEA test may just be the tool needed to enhance patient care.

The PreciseType^TM HEA Test Kit

PreciseType^TM HEA Test Kit provides 96 tests in two formats:

• 8-chip slides (12)
• 96-chip microplate (1)

• PCR, post-PCR, signal-development reagents, and a negative control
• Barcoded BeadChip slides/microplate and a disk with the chip-specific bead-map key for post-assay analysis

Proven Performance...Robust and Efficient

Serologic testing has long been an essential tool, but complex patient work-ups are labor-intensive:

• Building a complete donor profile can take several days^2,3
• Allocating time to complex workups and retaining an adequate red blood cell inventory can overwhelm precious resources⁴

As a result, only a small number of donors are typed for a few antigens, and antigen-negative and rare donor registries are limited.⁵

A complement to serologic testing

PreciseType^TM HEA test generates detailed genotypic and phenotypic patient profiles—a critical component of the medical health record—which allows donor centers to overcome many of today’s limitations by:

• Simplifying the identification of rare antigens
• Enables routine characterization of donor units for the most relevant antigens
• Determining true antigen make-up of recently transfused patients
• Remaining unaffected by autoantibodies or differences in reagent reactivity

Perhaps most important, as a Test of Record, PreciseType^TM HEA Test results require no confirmation with antisera—which may save time and reduce costs compared with experimental, Research Use Only (RUO) molecular tests that do require confirmation.

Streamline donor management

PreciseType^TM HEA test will help to streamline donor management by providing a range of important benefits to donor centers:

• Identifying and maximizing use of red blood cell units containing rare antigens
• Providing phenotype-matched products for special patient populations
• Enabling efficient delivery of antigen-negative products for patients with alloantibodies
• Facilitating customized blood drives and targeted donor recruitment

By storing extended antigen data for later retrieval, many centers may be able to reduce the need for repeat testing, substantially enhancing workflow and processes.

Raising the Standard of Care: Advantages of Molecular Technology

Knowledge is power 

Multiply-transfused patients are at increased risk of developing hemolytic reactions and alloimmunization — a serious problem with lifelong consequences.⁴ The risk is also elevated for multiparous women, who are more likely to develop antibodies from contact with fetal blood.^6–8

Test results can be applied to a number of clinical situations

PreciseType^TM HEA test generates detailed molecular information from patient and donor samples, rapidly detecting genotypes for accurate prediction of phenotypes. By providing more detailed and specific information regarding clinically relevant antigens faster than is possible with serology, PreciseType^TM HEA test results can be applied to a number of clinical situations, and it may enhance patient care in certain situations, including⁴:

• Recently transfused patients
• Patients with autoantibodies
• Chronically transfused patients
• Patients with:
• SCD
• Thalassemia
• Autoimmune hemolytic anemia
• Prenatal testing:
  • Genotype fetal DNA to predict risk for HDFN

For some users, data from PreciseType™ HEA Tests will also enable the creation of a detailed database containing antibody and molecular antigen typing information.

For additional information on pay or coverage, please call 855.466.8267 or contact your local Molecular and Specialty Diagnostics Business Manager.

With health conditions that require frequent transfusions, patients and their families depend on a close match between donors and recipients. Compatibility helps to ensure that transfusion reactions and other, potentially serious, problems can be avoided.

PreciseType^TM HEA provides doctors with highly detailed, genetic information about blood so they can make better matches between donors and recipients. Information from this test helps prevent mismatches that can cause potentially life-threatening reactions.

To find out how molecular antigen testing – which uses the genetic information from whole blood to increase the probability of transfusion compatibility – can provide benefits in a variety of medical conditions and situations, click here.

References

1. PreciseType^TM HEA Test Package Insert.
2. Westhoff CM. Molecular testing for transfusion medicine. Curr Opin Hematol. 2006;13:471–475.
3. Kochman SA. Role of the Food and Drug Administration in the use of molecular techniques in immunohematology. Transfusion. 2007;47(1 Suppl):3S–9S.
4. Hillyer CD, Shaz BH, Winkler AM, Reid M. Integrating molecular technologies for red blood cell typing and compatibility testing into blood centers and transfusion services. Transfus Med Rev. 2008;22:117–132.
5. Karpasitou K, Drago F, Crespiatico L et al. Blood group genotyping for Jk(a)/Jk(b), Fy(a)/Fy(b), S/s, K/k, Kp(a)/Kp(b), Js(a)/Js(b), Co(a)/Co(b), and Lu(a)/Lu(b) with microarray beads. Transfusion. 2008;48:505–512.
6. Blumberg N, Peck K, Ross K, Avila E. Immune response to chronic red blood cell transfusion. Vox Sanguinis. 1983;44:212–217.
7. Shirey RS, Boyd JS, Parwani AV, Tanz WS, Ness PM, King KE. Prophylactic antigen-matched donor blood for patients with warm autoantibodies: an algorithm for transfusion management. Transfusion. 2002;42:1435–1441.
8. Issitt PD, Combs MR, Bumgarner DJ, Allen J, Kirkland A, Melroy-Carawan H. Studies of antibodies in the sera of patients who have made red cell autoantibodies. Transfusion. 1996;36:481–486.