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Molecular Research and Development

The Molecular Research and Development Section provides support to the Specialised Laboratory Services (SLS) Department, by researching and developing current technologies and keeping abreast with the new advances in technology allows us to achieve the level of excellence and service provided by blood transfusion services worldwide.

A major part of molecular research and development is the evaluation of new reagents/techniques and platforms including next generation sequencing (NGS) suitable for the South African environment.

The formation of a Molecular Hub at both the Constantia Kloof and the new Mount Edgecombe (currently at Pinetown) premises will become a centralized area where molecular based processes will be optimized and developed in a state-of-art facility with multi-skilled cross functional staff. Fully automated, optimized and streamlined workflows will be implemented, research and publications of novel data will be encouraged, post-graduate studies will be supported in this field and collaborations both nationally and internationally will be initiated.

GENOTYPING

SANBS is a leader in offering state of the art genotyping technology for Human Leucocyte Antigen (HLA), Red Blood Cell (RBC) genetic analysis and human platelet antigen (HPA) characterisation. Through continuous development and innovations SANBS introduced red blood cell genotyping of 11 blood group systems in one test for high throughput genotyping and a fully automated real-time red cell genotyping assay for individual red cell genotyping of up to 13 blood groups including RHCE and RHD gene in one assay. The market will continued to be scanned for more cost-effective and cost-efficient procedures.

NEXT GENERATION SEQUENCING (NGS)

A major impact in testing became possible following the introduction of next generation sequencing (NGS) as HLA NGS tests revealed the uniqueness of the South African population and the need to characterize the various ethnic groups within South Africa.

HLA NGS provides high resolution HLA typing to improve the chances of finding more donor-recipient solid organ and bone marrow matches.

WHAT’S NEW?

1. Recent advances in technology allowed for the evaluation of an ABO next generation sequencing assay that followed HLA in highlighting the uniqueness of the South African population. In the pipeline is an evaluation of an RH NGS assay.
2. KIR (Killer-Immunoglobulin-like Receptor) Typing – KIR typing has been implemented in R&D to explore further the KIR-HLA and KIR-HIV associations for the role of KIR in the reduction of graft-vs-Host disease and in HIV disease progression.
3. Centre of Excellence for HLA NGS testing to build technical capacity and experience in interpretation and analysis of next generation sequencing results. This will be run in conjunction with the Translational Research section and offers an opportunity to train and develop people both in South Africa and Africa.

Contact details
Molecular Research and Development laboratory – 031 719 6953/6512

Email: lavendri.govender@sanbs.org.za

Specialised Laboratory Services: Immunohaematology Reference, Red Cell Serology and Reagents Laboratories

Background

The Immunohaematology laboratories of the Specialised Laboratory Services Department provide a range of services, in the form of support testing and reagent production to internal SANBS operations for the provision of safe blood and blood products, as well as to external customers from within the private and provincial sector as required.

These SANAS accredited laboratories, are operational on weekdays from 08h00 to 16h00.  After-hours testing support is available 24/7 from the Reference and Red Cell Serology Laboratories by contacting the dedicated staff member on call.  See below for details.  A Pathologist, who is available for consultation, overseas the laboratories, while the Manager, Immunohaematology, manages the laboratory operations.

A wide range of laboratory tests and techniques are employed, together with state-of-the-art automation and molecular-based assays.  All laboratory staff are fully qualified and registered with the Health Professions Council of South Africa.

The laboratories are supported by a Research and Development unit, which researches the market for developments and new assays within this field, actively validating them for the South African environment.

There are two Red Cell Serology (RCS) Laboratories; one situated in Constantia Kloof, Roodepoort and the other in Mount Edgecombe, KZN.  The Reference and Reagents Laboratories are both also located in Mount Edgecombe.

Contact details:

Pathologist: 011 761 9277

Manager, Immunohaematology: 011 761 9210

Red Cell Serology, Constantia Kloof: 011 761 9208 / 9209 / 9261

Red Cell Serology, Constantia Kloof: on-call: 082 857 1497

Red Cell Serology, Kwa Zulu Nata: 031 7196697 / 6685 /6693

Red Cell Serology, Kwa Zulu Natal: 072 022 6241

Reference Laboratory: 031 719 6544 / 6861 /6965

Reference Laboratory on-call: 072 022 3651

Reagents Laboratory: 031 719 6662 / 6684 /6689

Antenatal testing

Antenatal tests are performed on pregnant women in order to determine if obstetrically significant antibodies are present in their samples. The antenatal programme is aimed at preventing or managing Haemolytic Disease of the Foetus and Newborn (HDFN).

HDFN is a condition arising from incompatibility between a woman’s blood type and that of the foetus she is carrying.  In these cases, the red cell of the foetus possesses red cell antigens, inherited from the father, which are lacking in the mother. The mother’s immune system recognizes these antigens on the foetus’s red blood cells as foreign, and forms specific antibodies to them.  These antibodies may then cross the placenta and attach to the antigens on the foetal red cells. This leads to increased destruction of the foetal red blood cells and the foetus becomes increasingly anaemic.  Intra­uterine death may occur in severe cases.

The antibody most commonly implicated in HDFN is Anti-­D.  Rh negative individuals lack the D antigen on their red cells, and may develop Anti-­D if exposed to Rh positive blood, either through transfusion or pregnancy.

Antenatal testing performed by the Red Cell Serology Laboratories includes Rh type confirmation, as well as screening for, and identification of, irregular red cell antibodies. Monitoring of Irregular red cell antibodies of obstetric significance is performed by means of titration testing, and the results reported to the treating doctor or antenatal clinic.

Screening for and identification of irregular red cell antibodies

In some cases, difficulties may be experienced in obtaining compatible blood for patients at the blood bank.  Incompatibilities may arise in individuals who have been exposed to red cell antigens which are different to their own, either through pregnancy or blood transfusion, leading to the development of irregular red cell antibodies.  These cases are referred to the Red Cell Serology or Reference Laboratories for further investigation and resolution.  Irregular red cell antibody specificities are identified and assistance is provided to the blood banks for obtaining of suitable compatible blood.

Irregular red cell antibodies detected in blood donor samples are also investigated by these laboratories.

Irregular red cell antibody screening and identification is performed on request for external clients, the results of which are requirements in the manufacture processes of pharmaceutical products as well as in the diagnosis of specific medical conditions.

Red cell phenotyping and genotyping

Red cell typing, by manual/automated phenotyping techniques and molecular PCR-based methods is performed.  These tests are used in the sourcing of suitable blood for patients with irregular red cell antibodies, assistance in the resolution of difficult blood banking cases, identification of specific blood types within the blood donor population, in antenatal testing and for external clients on request.

Provision of blood for patients with rare blood types

Some individuals possess very rare blood types.  These rare types do not affect the health of the individual, however, complications may arise when transfusions are required as blood donations of the corresponding rare type are usually required.  A blood type is considered rare if found in ≤1% of the population.  Donors identified to possess rare types are very scarce, and are asked to join the South African Rare Donor Programme.

The Reference Laboratory is the custodian of the South African Rare Donor Programme, which facilitates the provision of blood for patients with rare blood types, both nationally and internationally.  This programme is linked to the International Rare Donor Registry, which coordinates the international provision of rare donations, ensuring that patients with rare types have access to suitable blood from around the world.

When the need for a rare unit is identified, fresh rare donations may be available in stock, or rare donors may be contacted directly and requested to donate a unit.  Blood donors possessing rare blood types are encouraged to remain regular donors for as long as they are able, and their donations, if not immediately required, are stored for up to 10 years in our rare frozen unit repository.  This ensures availability of rare type units when needed.

Transfusion reaction investigations

Occasionally, patients may experience an unexpected or untoward reaction to their transfusion of blood or blood products.  A full investigation is performed on each case reported to SANBS.  All cases are forwarded to the Red Cell Serology Laboratories, which coordinate any further investigations and testing.  The final outcome of these investigations is referred to the SANBS Haemovigilance office, which reports all results as part of the National Haemovigilance Programme.

Test summary

Sample labelling

• Label all samples with two forms of identification.
• Name and surname is mandatory.
• The second form of identification may include:
  • ID number
  • Date of birth
  • Date sample drawn
  • Hospital or clinic number
  • Unique case number
• Incorrectly labelled samples will result in the required testing not being performed.

Sample transport and packaging

Samples for the abovementioned testing must be packaged and transported appropriately:

1. Samples must be kept cool (refrigerated temperature, approximately 2 – 10ºC.
2. Separated plasma/serum samples may be frozen. Please ensure that red cell samples do not freeze.
3. In order to protect both the courier and the sample integrity, place blood samples into a plastic sleeve or sample envelope, thereafter placed into a suitable transport container.

Reagent production

The Reagents Laboratory provides various blood grouping antisera and reagent red cells to the SANBS laboratories and to external customers for the testing of patient and donor samples. Included are the reagents required for automated blood grouping of all blood donations received by SANBS. The reagent red cells include panel and screening cells required for the identification of red cell antibodies in patients and donors. Rapid Rh Typing Kits are prepared for use in the Emergency Blood Banks located throughout the country.

For a full list of our reagents and current prices, please refer to the Product Price List.

https://sanbs.org.za/product-price-list/

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https://sanbs.org.za/wp-content/uploads/2023/02/MSDS-Plasma-Reagents.doc

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reagents.doc

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Dear Reagent Laboratory Customer

Please find below the antisera and red cell reagent dispatch schedule for 2023

Reagents Laboratory frequently asked questions (FAQ)

https://sanbs.org.za/wp-content/uploads/2023/10/External-customers-ordering-Schedule-2024.pdf

Email to: Luandri.Wiese@sanbs.org.za, Nondumiso.Tekete@sanbs.org.za, Pragashni.Govender@sanbs.org.za, Nadhira.Kasopersad@sanbs.org.za, Siphokazi.Sidlayi@sanbs.org.za, Deas.Govender@sanbs.org.za, Support.SLS-ReagentsLaboratory@sanbs.org.za,    or contact: 031-719 6662/6604/6605/6689

Tissue Immunology

Background

SANBS vision is to be “The cornerstone of Health Care in South Africa, through the gift of Life”.  The Tissue Immunology Laboratories align with this vision by performing tissue compatibility testing for transplants and have been doing so since the 1970’s. We remain a key role player in South Africa and Africa, offering testing to facilitate solid organ, stem cell and bone marrow transplants. Additional stakeholder support includes Platelet Immunology and Immunohematology testing. Human platelet antigen and antibody testing is essential in identifying and treating Neonatal Alloimmune Thrombocytopenia (NAIT), Platelet refractoriness (PR) and transfusion reaction investigations.

The Tissue Immunology laboratories are overseen by a Pathologist who is available for consultation and two Senior Biomedical Scientists who manage the laboratory operations.

Please know that the laboratories treat all patient and donor information and data confidential and complies with the POPI (Protection of Personal Information) act.

SANBS has two state-of-the-art Tissue Immunology Laboratories, one in Johannesburg based in Constantia Kloof and the other in Durban based in Pinetown. These laboratories are SANAS accredited and are preparing for EFI (European Federation of Immunology) accreditation. Both laboratories are well equipped to provide an uninterrupted service to our clients on a 24/7/365 basis.  The laboratories are supported by a Research & Development unit, which researches the market for developments and new assays in this field and actively validates these for the South African environment. This support has enabled the placement of the NGS platform approximately 4 years ago.

SANBS assist and has a collaborative relationship with the South African Bone Marrow Registry (SABMR) and the Sunflower Fund (SF). Blood samples are collected from healthy volunteer donors who are then HLA tested by DNA or NGS technology. The test results are released to the SABMR and SF who capture and include the HLA results onto the national donor register. Should you require further information on how to become a bone marrow donor, please contact the

• SABMR on 021 447-8638 or www.sabmr.co.za
• SUNFLOWER FUND on 0800 121082 or www.sunflowerfundregistry.com

HLA Testing

Over the last 30 years, there has been a rapid evolution in HLA technology. The Tissue Immunology laboratories have embraced the advances and are able to offer a wide range of tests to support the transplant community.

The list includes:

• ABO Grouping and antibody titres for monitoring of ABO incompatible transplants.
• Rapid HIV Screening – Gauteng only for cadaver donor testing.
• CDC (T and B cell) and Virtual Cross matching.
• Molecular Class I and II HLA typing on recipients and donors, utilising rSSO technology.
• Next Generation Sequencing testing is available for high resolution HLA typing for all 11 loci for the Bone Marrow registry, privately paying patients as well as the provincial health sector.
• HLA antibody identification (Single Antigen assay) is performed using a Luminex® bead-based multiplexing technology.
• Human platelet antibody identification is performed using Luminex xMAP technology. This assay is used to detect antibodies to HPA-1, HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and to Glycoprotein groups.
• Human platelet genotyping is performed using Luminex xMAP technology. This assay detects HPA 1 – 11 & 15.

Click here to download the Tissue Immunology request form

https://sanbs.org.za/wp-content/uploads/2019/09/FRM-SLS-091.1-Tissue-Immunology-Request-Form.pdf

Click here to view INF-SLS-040

https://sanbs.org.za/wp-content/uploads/2019/09/INF-SLS-040.0-Information-Related-To-Blood-Samples-Int.doc

The turn-around times

• Cadaver donor testing (CDC, Virtual crossmatching and HLA typing) is 6 – 12 hours.
• CDC crossmatches have a 48-hour TAT.
• Non-urgent HLA and Platelet Immunology tests are available within 15 working days. In consultation with the pathologist or laboratory manager, special arrangements can be made.
• High resolution HLA testing is performed twice a month and therefore currently only suitable for elective cases.

Contact details

Tissue Immunology laboratory, Johannesburg:     (011) 761 9227/8 or

_.SLS-TissueImmunologyCK@sanbs.org.za

Tissue Immunology laboratory, Pinetown:             (031) 719-6618/9 or

_.SLS-TissueImmunologyPTN@sanbs.org.za

Please know that the office hours of the Tissue Immunology laboratories are 08h00 to 16h00.

Genetics

Background

The SANBS Genetics laboratory, based in KwaZulu-Natal (KZN), has provided prenatal and postnatal diagnostic services to private and public funded patients in this province since 1964.

The laboratory, which is SANAS accredited, is fully staffed on weekdays from 08h00 to 16h00 and an afterhours consultation service is available 24/7 on a dedicated number, see below for details.

A Pathologist who is available for consultation oversees the Genetics laboratory while the Senior Biomedical Scientist manages the laboratory operations.

The laboratory is supported by a Research & Development unit, which researches the market for developments and new assays in this field and actively validates these for the South African environment.

Genetic counselling can be arranged on request for private patients at the SANBS headquarters in Pinetown, while provincial patients receive counselling at the genetic clinics that are held weekly at certain hospitals.

Genetic Testing:

Cytogenetic studies include both traditional cytogenetic techniques (cell culture and karyotyping) as well as molecular cytogenetics by Quantitative fluorescent PCR (QF-PCR) for rapid detection of the most common aneuploidies (13, 18, 21, X and Y).

The alphafetoprotein level is also routinely tested on amniotic fluid specimens between 13 and 29 weeks gestation to screen for open neural tube defects. This test is outsourced to a SANAS accredited laboratory.

Specimen types received by the laboratory include peripheral and cord blood, amniotic fluid, products of conception, and skin.

Kits which include the relevant collection tubes, request forms and envelope for despatch of the sample to the laboratory, are available on request from the laboratory on the contact details supplied below.

• Request form for peripheral and cord blood chromosome analysis and/or QF-PCR testing (FRM-SLS-136) and
• Request form for amniotic fluid chromosome analysis, alphafetoprotein screening and/or QF-PCR testing (FRM-SLS-139).

Note:

• Laboratory Hours are Monday to Friday, 08h00 to 16h00
• All patient information is treated as confidential and the laboratory complies to the POPI (Protection of Personal Information) act

Contact details:

Landline:  (031) 719-6607/6541

24/7 cell:  082- 894 0752

Group email:  SLS-Cytogenetics@sanbs.org.za

FRM-STS-048.1 Informed Consent for Therapeutic Apheres

FRM-STS-049.1 Request for Therapeutic Apheresis Proced

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The Cellular Therapy Laboratory (CTL) is located at the SANBS head office in Constantia Kloof, Johannesburg. CTL is responsible for processing, cryopreserving, and storing hemopoietic stem cells for bone marrow transplant and the production of Serum Eye Drops from whole blood for patients with a severe ocular surface disease such as dry eye syndrome.

To assist with accurate and reliable CD34 enumeration for hemopoietic stem cell collection and reinfusion, CTL performs CD34 enumeration by flow cytometry. This includes pre-harvest, mid-harvest, end-harvest, and post-thaw CD34 and CD45 enumeration as well as automated trypan blue.

CD3 enumeration is performed for Donor Lymphocyte Infusions.

CTL has routine operational hours of 7 am to 3 pm, Monday to Friday. There is also a 24-hour on-call service for emergency requirements.

Reference intervals and clinical decision values:

Pre-CD34: recommended being ≥20 cells/µl prior to hemopoietic stem cell collection

End harvest CD34: recommended being ≥2 x10⁶/kg (multiple myeloma: recommended to be ≥5 x10⁶/kg)

Post thaw viability: CD45 ≥50%, CD34 ≥70%

For Serum Eye Drops production, sterility testing is performed by the Quality Control Laboratory, and infectious disease marker testing is performed by Donation Testing Laboratory both of which are located at the SANBS head office in Constantia Kloof, Johannesburg.

Lab Head: Bibi Rhode

Lab Director: Tanya Glatt

Contact details: office hours: 011 761 9264; call phone: 064 860 8619; email: CTLTeam@sanbs.org.za

Customers can complete FRM-STS-045 to request stem cell related flow cytometry testing. All transport arrangements are made by the Specialised Therapeutics Service department of SANBS.