external quality assurance catalog 2020

EXTERNAL QUALITY ASSURANCECATALOG 2020

www.rhenium-medical.co.il

Chemistry & Endocrinology

Immunology

Leucocyte Immunophenotyping

Haematology

Microbiology

Histocompatibility & Immunogenetics

Pathology

Andrology

Key Notes

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Rhenium Medical Ltd. www.rhenium-medical.co.il 20 Hasatat St. P.O.B 180, Modi'in, 7171101, Israel, T 972-8-9558847 T 972-8-9558865 [email protected]

Rhenium Medical4


Programme name Catalog Number Number Of Distributions

Number Of Samples Per Distribution

Material Distributed

Clinical Chemistry CC1GEN1A 12 3 Human serum

Included Analytes

Sodium Potassium Chloride Bicarbonate Urea Creatinine

Urate Glucose Lactate Calcium Adjusted Calcium Phosphate

Bilirubin D-3-hydroxybutyrate Iron UIBC TIBC Total protein

Albumin Lithium Magnesium Copper Magnesium Copper

Zinc Osmolality AST [ASAT] ALT [ALAT] LD CK

ALP [Alk Phos] Amylase GGT Lipase

Lipid Investigations CC1LIP1A 12 3 Human serum

Included Analytes

Total cholesterol Triglyceride HDL cholesterol non-HDL cholesterol LDL cholesterol Apo B

Apo A1 Lp(a) Homocysteine

Specific Proteins CC1PROTA 12 3 Human serum

Included Analytes

IgG IgA IgM C3 C4 Alpha-1-antitrypsin

Haptoglobin Transferrin Caeruloplasmin Transthyretin Alpha-2-macroglobulin

Immunochemical Albumin

Sweat Test CC1SWT1A 12 3 Sterile H2O

Included Analytes

Sweat Chloride Chloride interpretation Sweat Conductivity Conductivity interpretation

Sweat Sodium

Cholinesterase Investigation CC1CHE1A 6 3 Human serum

Included Analytes

Butyrylcholinesterase activity Dibucaine number Fluoride number RO2-0683 number Scoline number

Chloride number Interpretative comment

1

1

1

1

1

External Quality Assurance Catalog 2020 5




Glycated Hemoglobins CC1GHB2A 12 3

Human whole blood anticoagulated with EDTA or Human whole blood (anticoagulated) supplied as separate cells and plasma

Included Analytes HbA1c [IFCC] HbA1c [DCCT]

Pediatric Bilirubin CC1PBILA 12 3 Human serum

Included Analytes

Bilirubinometers Total bilirubin Conjugated bilirubin

Urinary Cathecolamine CC1CAT1A 12 5 Human urine

Included Analytes

Metadrenaline Normetadrenaline 3-methroxytyramine VMA [HMMA] HVA Noradrenaline

Adrenaline Dopamine 5HIAA

Urine Dipstick Testing CC1DSTCA 12 2 Human urine

Included Analytes

Bilirubin non-haem Blood Glucose Keytones Leucocytes Nitrite

pH Protein Specific Gravity Urobilinogen Ascorbic Acid

Intrinsic Factor H24IFABA 4 4 Human serum

Included Analytes

Intrinsic Factor Ab IF Ab interpretation

Haematinics H24THREA 12 3 Human serum / Whole Blood

Included Analytes

B12 Folate Ferritin Red Cell Folate

1

1

1

1

1

1

Hematinics Additional System H24THRBA 12 3 Human serum / Whole Blood

Included Analytes

B12 Folate Ferritin Red Cell Folate

1

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Urine Chemistries CC1URINA 12 3 Human urine

Included Analytes

Urinary Albumin Urinary Amylase Urinary Calcium Urinary Chloride Urinary Creatinine Urinary Glucose

Urinary Magnesium Urinary Phosphate Urinary Potassium Urinary (Total) Protein Urinary Sodium

Urinary Urate Urinary Urea Urinary Osmolality ACR PCR non-dipstick pH

Vitamin Assays CC1VITAA 12 3 Human serum

Included Analytes

Vitamin A Vitamin E Beta carotene Alpha carotene Beta cryptoxanthin Lutein + Zeaxanthin

Lycopene Zeaxanthin

LIH INDEX CC1HIL1A 12 4 Human serum

Included Analytes

Analyte ‘X’ Analyte ‘X’ Interpretation Haemolysis Index Haemolysis Category Icterus Index

Icterus Category Lipaemia Index Lipaemia Category

Holotranscobalamin (HOLO TC) H24HOLOA 12 3 Human serum

Included Analytes

MMA Holo TC Holo TC interpretation

Faecal Haemoglobin CC1FAECA 6 3 Artificial faeces

Included Analytes

FOB card - window 1 FOB card - window 2 FIT card - strip 1 FIT card - strip 2 FIT result (buffer) FIT result (stool)

FIT dipstick result FOB in-house Overall interpretation (non-FIT) Overall interpretation (FIT)

1

1

1

1

1

Quantitative Phenylalanine CC1PHENA 12 3 Human serum

Included Analytes

Phenylalanine Tyrosine Leucine Isoleucine Valine

1





Newborn Screening CC1NBS1A 12 3 Card

Included Analytes

Initial TSH Initial TSH Interpretation Final TSH CHT interpretation Initial IRT

Initial IRT interpretation Final IRT CF interpretation Initial Phe

Initial Phe interpretation Final Phe Tyr PKU interpretation Initial C8

Initial C8 interpretation Final C8 C10 C8/C10 ratio

MCADD interpretation C5 C5DC Leu Met

Antibiotic Assay CC1ATBUK 12 3 Human serum

Included Analytes

Amikacin Gentamicin Teicoplanin Tobramycin Vancomycin

Salicylate & Paracetamol CC1SAPAA 12 3Human serum/Human Serum Albumin

Included Analytes

Salicylate Paracetamol

Antifungal Panel CC1FUN1A 6 3 Human serum

Included Analytes

Flucytosine Itraconazole Hydroxyitraconazole Posaconazole Voriconazole

1

1

1

1

Faecal Pancreatic Elastase Pilot CC1PANCR 12 3 Human faeces

Included Analytes

Faecal Pancreatic Elastase

Birmingham Quality Health Checks CC1PANCR 6 3 Human Serum

Included Analytes

Total cholesterol HDL cholesterol Triglyceride LDL cholesterol Non-HDL cholesterol TC/HDL ratio

Glucose

1

1

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Colorectal Cancer Screening CC1COLOR 6 3 Artificial faeces

Included Analytes

FOB Tab 1 Rectangle 1 FOB Tab 1 Rectangle 2 FOB Tab 2 Rectangle 1 FOB Tab 2 Rectangle 2 FOB Tab 3 Rectangle 1 FOB Tab 3 Rectangle 2

Stool 1 Window 1 Stool 1 Window 2 Stool 2 Window 1 Stool 2 Window 2 Stool 3 Window 1 Stool 3 Window 2

Patient Card

Faecal Markers of Inflammation CC1FMOA1 12 3 Human faeces

Included Analytes

Calprotectin POCT Calprotectin Calprotectin interpretation Lactoferrin

Lactoferrin interpretation Lactoferrin free text interpretation S100-A12

Porphyrins Urine CC1PORPU 6 2 Lyophilised Urine

Included Analytes

Urine Total Porphyrin Quantitative Porphobilinogen Qualitative Porphobilinogen Urine ALA

Urine Porphyrin Components

Aluminium in Water/Dialysis Fluid CC3ALDIA 12 2 Water\dialysis

Included Analytes

Aluminium

Serum Zinc & Copper CC3CUZNA 12 2 Bovine serum

Included Analytes

Zinc Copper

Urine Zinc & Copper CC3TEURA 12 2 Human urine

Included Analytes

Zinc Copper

2

2

2

1

1

1






Urine Aluminium CC2ALSE 12 2 Human urine

Included Analytes

Aluminium

Lead & Cadmium in Blood CC1LEADB 12 3 Equine whole blood

Included Analytes

Lead Cadmium Chromium Cobalt

Trace Elements in Serum CC1TESER 12 2 Human Serum

Included Analytes

Zinc Copper Aluminium Selenium Chromium Cobalt

Trace Elements in Urine CC1TESUR 12 2 Human Urine

Included Analytes

Mercury Cadmium Copper Iron Zinc Chromium

Cobalt Arsenic Lead Manganese Nickel Thallium

Selenium

Vitamin K1 H25VITK1 3 3Unmodified, depleted and spiked serum and ethanolic standards

Included Analytes

Vitamin K1 (phylloquinone)

Vitamin K1-2,3-epoxide H25VIT23 3 2 Spiked serum and ethanolic samples

Included Analytes

Vitamin K1-2,3-epoxide

2

2

2

2

17

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Troponin CC1TROPA 12 3Lyophilised human serum matrix with analyte additions

Included Analytes

Troponin

Troponin, CKMB, Myoglobin, BNP CC1TCMBA 12 3Lyophilised human serum matrix with analyte additions

Included Analytes

Troponin CKMB Myoglobin BNP

BNP or NT-ProBNP CC1BNPA 12 3Lyophilised human serum matrix with analyte additions

Included Analytes

BNP or NT-ProBNP

Troponin BNP Or NT Pro BNP CC1TRBNA 12 3Lyophilised human serum matrix with analyte additions

Included Analytes

Troponin BNP Or NT Pro BNP

Steroid Hormones - 1 Analyte CC1ST01A 12 3 Human serum

Included Analytes

Cortisol Urinary Free Cortisol 17OH-Progesterone Progesterone Oestradiol [E2]

Oestradiol [high-level] Testosterone [female] Testosterone [male]

Free Testosterone SHBG Androstenedione DHA sulphate Aldosterone


Included Analytes




3

3

3

3

1

1







Included Analytes





Included Analytes





Included Analytes





Included Analytes





Included Analytes




1

1

1

1

1

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Included Analytes





Included Analytes





Included Analytes





Included Analytes





Included Analytes




1

1

1

1

1






Thyroid Related Hormones CC1THY1A 12 5 Human serum

Included Analytes

TSH Free T4 Free T3 Total T4 Total T3

Erythropoietin H24EP01A 12 3 Human serum

Included Analytes

Serum Erythropoietin

Thyroglobulin & ANTI-TG CC1TYROA 12 3 Human serum

Included Analytes

Thyroglobulin TgAb - numeric result TgAb - interpretation

GFR Estimations [eGFR] CC1EGFR1 12 3 Human serum

Included Analytes

Serum creatinine eGFR (CKD) eGFR CKD-EPI SCr Cystatin C eGFR CKD-EPI Cys

Insulin, C-Peptide, Gastrin, IGF-1 CC1FOURA 8 3 Lyophilised human serum

Included Analytes

Insulin C-Peptide Gastrin IGF-1

Insulin, C-Peptide, Gastrin CC1THREA 8 3 Lyophilised human serum

Included Analytes

Insulin C-Peptide Gastrin

4

4

1

1

1

1

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IGF-1 CC1IGF1A 8 3 Lyophilised human serum

Included Analytes

IGF-1

NTD & Downs Screening 1+2 Trimester CC1AD12A 12 3(NTD) + 3(Down’s) Liquid human serum

Included Analytes

hCGß hCGß MoMs PAPP-A PAPP-A MoMs hCGß MoMs AFP

AFP MoMs hCG / hCGß hCG / hCGß MoMs Unconjugated oestriol (uE3) Inhibin A

Inhibin A MoMs Pregnancy associated plasma protein A (PAPP-A)

Downs Screening in the First Trimester CC1MSFTA 12 3 Liquid human serum

Included Analytes

Free B-subunit of hCG and PAPP-A

NTD & Downs Screening in the Second Trimester CC1DOWNA 12 3 (NTD)+3 (Down’s) Liquid human

serum

Included Analytes

AFP Intact hCG Free B-subunit of hCG Unconjugated oestriol Inhibin A

AFP,hCG,CEA CC1AHCEA 12 5 Liquid human serum

Included Analytes

AFP hCG CEA

FSH, LH, Growth hormone & prolactin CC1FLGPA 12 5(FSH, LH, Prolactin) + 4(Growth Hormone)

Liquid human serum

Included Analytes

FSH LH Growth hormone Prolactin

5

5

5

5

5

4



PTH CC1PTH1A 6 4 Lyophilised human serum

Included Analytes

PTH

AMH - Anti Mullerian Hormone CC1AMH1A 12 5 Liquid human serum

Included Analytes

AMH

hCG CC1HCG1A 12 5 Liquid human serum

Included Analytes

hCG

Calcitonin CC1CTONA 6 3 Lyophilised human serum

Included Analytes

Calcitonin

PTH, ACTH, CALCITONIN CC1PACTA 6 4(PTH) + 3(ACTH) + 3(Calcitonin)

Lyophilised human serum

Included Analytes

PTH ACTH CALCITONIN

ACTH CC1ACTHA 6 3 Lyophilised human serum

Included Analytes

ACTH

CEA CC1CEA1A 12 5 Liquid human serum

Included Analytes

CEA

5

5

5

5

5

5

5




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AFP CC1AFP1A 12 5 Liquid human serum

Included Analytes

AFP

FSH, LH, prolactin CC1FLPRA 12 5 Liquid human serum

Included Analytes

FSH LH Prolactin

Placental growth factor (PlGF) CC1PIGF1 12 3 Liquid human serum

Included Analytes

1st trimester Down’s syndrome (dried blood spots) CC1DRIED 12 5 Dried blood spots

Included Analytes

hCGβ hCGβ MoMs PAPP-A PAPP-A MoMs

Risk of Down’s syndrome (at sampling or at term, biochemistry ± nuchal translucency)

5

5

5

5

25-OH Vitamin D DD1HVTDA 4 5 Serum

Included Analytes

25-OH Vitamin D

1,25 Di-OH Vitamin D DD1DVTDA 4 5 Serum

Included Analytes

1,25 Di-OH Vitamin D

16

16


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Immunology




Free PSA C15PSAFA 12 2 Human serum

Included Analytes

free PSA complexed PSA

Nuclear antibodies (ANA/DNA) M15ANAAA 6 2 Human serum

Included Analytes

ANA dsDNA

Nuclear antibodies (ANA/DNA/ENA) M15ENAAA 6 2 Human serum

Included Analytes

ANA DNA ENA

Phospholipid antibodies M15CALAA 6 2 Human serum

Included Analytes

cardiolipin antibodies (IgG and IgM) B2Glycoprotein (IgG and IgM) phosphatidylserine

Coeliac Disease antibodies M15CD1A 6 1 Human serum

Included Analytes

Gliadin Endomysium Tissue Transglutaminase

CRP M15CRP1A 12 2 Human serum

Included Analytes

C-Reactive protein

C1 Esterase inhibitor and functional complement M15C1INA 4 4 Human serum

Included Analytes

Hereditary angioedema Complement activation

6

6

6

6

6

6

6





Cryoglobulin M15CRYOG 4 1 Virtual case study

Included Analytes

CRYOGLOBULIN

CSF Proteins and Biochemistry M15CSFAA 6 2 Artificial cerebrospinal fluid

Included Analytes

Total protein Albumin IgG Glucose Lactate

Breast markers (CA15-3) C15BREMA 6 2 Human serum

Included Analytes

CA15-3

Gut markers (CA19-9) C15GUTMA 6 2 Human serum

Included Analytes

CA19-9

Ovarian markers (CA125) C15C125A 6 2 Human serum

Included Analytes

CA125

Neuron Specific Enolase (NSE) C15LUNMA 6 2 Human serum

Included Analytes

Neuron Specific Enolase

Total PSA C15PSA1A 12 2 Human serum

Included Analytes

Total PSA

6

6

6

6

6

6

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B2 Microglobulin M15B2M1A 6 2 Human serum

Included Analytes

Serum Beta2 microglobulin in the monitoring of B-cell Malignancy

CRP Ultrasensitive M15CRPUA 12 2 Human serum

Included Analytes

CRP Ultrasensitive

Liver Disease Antibodies M15LKM1A 6 1 Human serum

Included Analytes

LKM AMA SMA

ANCA/GBM antibodies M15NECAA 6 2 Human serum

Included Analytes

Neutrophil Cytoplasmic Glomerular Basement Membrane (p-ANCA/c-ANCA Proteinase 3

Myeloperoxidase

Thyroid peroxidase antibody M15THABA 6 1 Human serum

Included Analytes

TPO

Diabetic Markers M15DIABA 6 2 Human serum

Included Analytes

Islet cell (ICA) Glutamic Acid Decaboxylase (GAD) Protein Tyrosine Phosphatase (IA2)

Protein Tyrosine Phosphatase (IA2) Insulin antibody (IA) Zinc Transporter 8 Antibody (ZnT8)

Diabetic Marker Autoantibody Screen




6

6

6

6

6

6

Immunology


Anaemia related antibodies M15GPCQA 6 2 Human serum

Included Analytes

Anaemia related antibodies

Monoclonal Protein Identification M15MONPA 6 2 Human serum and urine

Included Analytes

Total serum protein Albumin IgG IgA IgM

free light chains (Kappa, Lambda and ratio) urine total protein Monoclonal Component Quantitation

Rheumatoid Factor M15RHF1A 6 1 Human serum

Included Analytes

RF

Acetylcholine Receptor antibody M15ACRAA 4 3 Human serum

Included Analytes

ACR

Allergen Component Testing M15ALCO 6 2 Human serum

Included Analytes

Venom Egg Nuts Latex Birch Milk

Bone Metabolism MarkersMarkers-suspended M15BONEA 6 6 (2 x serum, 2 x

plasma, 2 x urine)Human serum and urine

Included Analytes

BSAP P1NP CTx (DPD Free and ratio Urine N-Telopeptide




6

6

6

6

6

6

Rhenium Medical22

Antibodies to Citrullinated Proteins M15CPABA 6 1 Human serum

Included Analytes

CP

IgG subclasses M15GSUBA 6 2 Human serum

Included Analytes

Total IgG IgG1 IgG2 IgG3 IgG4

CSF Oligoclonal bands M15CSFOA 6 2Human cerebrospinal fluid and serum sample

Included Analytes

CSF IgG Oligoclonal Bands

Bullous Dermatosis antibodies M15SKNA 6 1 Human serum

Included Analytes

Dermatosis Basement Membrane and Desmosome Antibodies

Total IgE M16IGE1A 6 2 Human serum

Included Analytes

TOTAL IgE

CSF Haem Pigments M15CSFHA 6 2 Normal or pathological CSF

Included Analytes

Haem Pigments




6

6

6

6

6

6

Immunology


Paraneoplastic antibodies M15PARAA 6 2 Human serum

Included Analytes

ANNA-1 (Hu) ANNA-2 (Ri) PCA-1 (Yo) CRMP5 (CV2) Amphiphysin, Ma-2 (Ta)

neurological GAD

Allergen Specific IgE Scheme M16ASIEA 6 2 Human serum

Included Analytes

D1 Dermatophagoides pteronyssinus E1 Cat epithelium E5 Dog dander F1 Egg white F2 Cow’s milk

F13 Peanut F17 Hazel nut G6 Timothy grass I1 Bee venom I3 Wasp venom K82 Latex

M3 Aspergillus fumigatus M6 Alternaria alternata T3 Birch W6 Mugwort

Ganglioside Antibody Markers M15GANGI 6 2 Human serum

Included Analytes

IgG IgM IgG/IgM GM1 GM2 GD1a

GD1b GQ1b

Interferon Gamma Release Assays (Mycobacterium tuberculosis) M15INTER 6 2 Human serum

Included Analytes

IGRA TB

Antibody to Fungal & Related Antigens M15FUNG1 6 2 Human serum

Included Analytes

Aspergillus fumigatus Candida albicans Pigeon Serum Pigeon Feathers igeon Droppings

Pigeon Mix Budgerigar Serum Budgerigar Feathers Budgerigar Droppings Budgerigar Mix

Micropolyspora faeni




6

6

6

6

6

Rhenium Medical24

Immunology

Specific Microbial Antibodies M15MICAN 6 2 Human serum

Included Analytes

Haemophilus Influenzae (HiB) Pneumococcus Tetanus and Pneumococcal Serotype

Tryptase M16TRYPA 6 2 Human serum

Included Analytes

Tryptase

Alpha 1 Antitrypsin Phenotype Identification M15ANTIT 4 2 Human serum

Included Analytes

Alpha 1 Antitrypsin PI Phenotyping

CSF ßeta 2 Transferrin & ßeta Trace Protein M15CSFB2 6 2 Human serum

Included Analytes

CSF ß2 Transferrin ß Trace Protein




6

6

6

6

Rhenium Medical26





BCR-ABL QUANTITATION H23BCRQA 3 Variable Lyophilised samples

Included Analytes

BCR-ABL Quantitation for the monitoring of Chronic Myeloid Leukaemia

CD34 Stem Cell H23ICDSA 6 2

Stabilised whole blood obtained from patients with leukaemia

Included Analytes

CD34+ stem cell enumeration

Immunofluresence Leukemia H23IFLUA 6 1

Stabilised whole blood obtained from patients with leukaemia

Included Analytes

Part 1: Assess a laboratory's ability to immunophenotype a leukaemia sample using flow cytometry and immunocytochemistry (where applicable) and allows participants to analyse the samples using antibodies against antigens of their choice as well as includ-ing mandatory core antigensPart 2: Designed to assess a laboratory's ability to diagnose leukaemia using a full spectrum of laboratory tests. This includes digital morphological images and other appropriate pathology tests

JAK2 (V617F) H23JAK2A 3 2 Lyophilised samples

Included Analytes

JAK2 V617F

MRD-ALL H23MRDEA 4 3Stabilised blood containing leukaemic cells

Included Analytes

MRD-ALL

MRD-AML H23MRDAL 4 3 Stabilised whole blood

Included Analytes

MRD-AML

7

7

7

7

7

7





MRD-CLL H23MRDCL 4 3 Stabilised whole blood

Included Analytes

MRD-CLL

FLT3 Mutation Status H23FLT3A 3 2Lyophilised cell-lines or patient derived material

Included Analytes

FLT-3 Internal Tandem Duplications (ITD)

mutation in the tyrosine kinase domain (KTD) leading to a D835V amino acid substitution

BRAF V600E Mutation for Hairy Cell Leukaemia H23BRMHA 3 2 Lyophilised

cell-lines

Included Analytes

BRAF V600E

NPM1 Mutation Status (NPM1) H23NPM1A 3 2Lyophilised cell-lines or patient derived material

Included Analytes

NPM1

IgH/TCR Clonality H23IGHCA 3 2 Lyophilised cell-lines

Included Analytes

CA19-9

Immune Monitoring H23IMONA 6 2 Stabilised whole blood

Included Analytes

CD3+ CD3+/CD4+ CD3+/CD8+ CD19+ CD16+/56+

7

7

7

7

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Rhenium Medical28





BCR-ABL+AML Translocations H23BCAMA 3 2 Lyophilised cell-lines

Included Analytes

t(9;22) BCR-ABL1 Major and Minor breakpoints t(8;21) (AML1-ETO or RUNX1-RUNX1T1)

t(15;17) (PML-RARα)

Post-SCT Chimerism Monitoring H23CHMSA 5 4 Fresh peripheral blood

Included Analytes

Chimerism

Low Level Leukocyte H23ILOWA 9 6 Whole blood and three platelet

Included Analytes

alculate the absolute count (cells/μL) of leucocytes in leucodepleted blood

Paroxysmal Nocturnal Haemoglobinuria (PNH) H23PNHIA 6 2

Material derived from consenting patients

Included Analytes

Percentage of PNH erythrocytes (total, type II and type III)

Total clone size as a percentage for both PNH granulocytes and PNH monocytes

BCR-ABL1 Kinase Domain Mutations H23BCKDA 2 3 Lyophilised cell-lines

Included Analytes

BCR-ABL1 Kinase Domain

c-KIT D816V Mutation Status H23CKTDA 3 2 Lyophilised cell-lines

Included Analytes

D816V -Systemic Mastocytosis

7

7

7

7

7

7





Pediatric Acute Leukaemia Translocations H23PACLA 2 2 Lyophilised

cell-lines

Included Analytes

t(12;21) (TEL-AML1 /ETV6-RUNX1) t(4;11) (MLL-AF4) t(1;19) (E2A-PBX1 or TCF3-PBX1)

NGS - Acute Myeloid Leukaemia Gene Panels H23NGSML 1 2 Acute Myeloid

Leukaemia samples

Included Analytes

Myeloid Leukaemia

Immune Monitoring Alternative Technologies H23IMOAT 6 2 Stabilised whole

blood

Included Analytes

Immune Monitoring via Coulter Aquios system CD3+ CD3+/CD4+ CD3+/CD8+

CD19 CD16+/56+

7

7

7

Rhenium Medical30

Haematology




Automated Differential Leucocyte Count H22ADLCA 6 2Material distributed is specific to the instrument type

Included Analytes

Neutrophils Lymphocytes Monocytes Eosinophils Basophils

Full Blood Count H22FBC2A 12 2 Partially fixed human whole blood

Included Analytes 8

8

Blood & Parasites Film H22FILMA

8 (Morphology), 4(Parasite), 4(Manual

differential)

2(Morphology), 2(parasite),

1(differential ) Stained films

Included Analytes

Blood Film Morphology Blood Parasite Identification Manual Differential Luecocyte Count

G6PD H22G6PDA 6 2 Whole blood

Included Analytes

Red Cell G6PD screening tests Red Cell G6PD quantitative assays

ESR H22ESR1A 4 2Commercially produced ESR material

Included Analytes

ESR

Point of Care Testing HB H22PCHBA 12 2 Whole blood

Included Analytes

Haemoglobin

8

8

8

8

Full Blood Count-Addional Instrument Eqc H22FBCAD 12 2 Partially fixed

human whole blood

Included Analytes 8

Hb RBC PCV MCV MCH MCHC WBC Platelets

Hb RBC PCV MCV MCH MCHC WBC Platelets





Whole Blood Reticulocyte Count H22RETIA 6 2 Whole blood material

Included Analytes

Reticulocyte

Cytochemistry H22CYTOC 4 2 Slides

Included Analytes

Iron stain (Perls’ stain) Sudan Black B (SBB) or Myeloperoxidase (MPO)

Red Cell Genotyping Pilot H20GENOA 4 2 x

Included Analytes

Digital Morphology H22DIGMA 8 1 Virtual case study

Included Analytes

Abnormal Hemoglobins H22ABHBA 6 3 Human whole blood

Included Analytes

Sickle screen tests Hb fraction identification Quantitation of HbA2, HbF and HbS as appropriate

Interpretative comments

DNA Diagnostics for Hemoglobinopathies H22DNAHA 3 2 DNA in solution

Included Analytes

Genetic mutations of the alpha and beta globin genes

8

8

8

8

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Haematology

Rapid Diagnostic Testing for Malaria (RDT) H22RDTMA 4 2 Haemolysate with

malarial antigen

Included Analytes

malarial antigen

Feto-Maternal Haemorrhage H27FMH1A 4 3Cord cells in CPD or EDTA mixed with adult cells in CPD

Included Analytes

Feto-maternal Haemorrhage Anti-D prophylaxis

Plasma Viscosity H22VISCO 12 2 Plasma

Included Analytes Plasma Viscosity

Newborn Sickle Screening H22NSSC1 12 3Dried blood spot newborn screening cards

Included Analytes

sickle haemoglobin and other clinically significant variant haemoglobins

Level 1 Blood Coagulation H25COA1A 6 3

Human, plasmapheresed/seperated, lyophilised plasma

Included Analytes

Prothrombin Time Quick’s one stage method Capillary reagent method

PT/diagnostic (PTD) tivated Partial Thromboplastin Time (APTT) Thrombin Time (TT)

Heparin Dosage Assessment (HDA) Heparin assay Fibrinogen Estimation D-dimer

Lupus anticoagulant

Level 1 Blood coagulation additional instrument H25CO1BA 6 3


Included Analytes

Prothrombin Time Quick’s one stage method Capillary reagent method

PT/diagnostic (PTD) tivated Partial Thromboplastin Time (APTT) Thrombin Time (TT)Heparin Dosage Assessment (HDA) Heparin assay Fibrinogen Estimation D-dimer

Lupus anticoagulant

8

8

8

9

9

8


Level 2 Blood Coagulation H25COA2A 3-6 5-10


Included Analytes

Factors II, V, VII, VIII, IX, X, XI, XII Factor XIII screen/assay Quantitative factor VIII inhibitor

Von Willebrand Factor antigen and VWF Antithrombin antigen and activity assays Protein C Protein SProtein S activity Plasminogen Assay APC resistance

Blood Coagulation Level 2 Supplementary H25SUPPL Variable Variable

Kindly contact Rhenium Medical for details

Included Analytes FVIII FVIII Inhibitor HIT Post Infusion Monitoring

Level 2 Blood coagulation additional instrument H25CO2BA 6 3

Human,plasma pheresed/seperated, lyophilised plasma




Included Analytes

Factors II, V, VII, VIII, IX, X, XI, XII Factor XIII screen/assay Quantitative factor VIII inhibitor

Von Willebrand Factor antigen and VWF Antithrombin antigen and activity assays Protein C Protein SProtein S activity Plasminogen Assay APC resistance

Factor V Leiden / Molecular Genetics of Thrombophilia H25FACVA 3 Variable

Citrated whole blood; lyophilised DNA

Included Analytes

Factor V Leiden P20210A

Blood Coagulation Point of Care H25PACTA please inquire details

please inquire details

please inquire details

Included Analytes

Lupus Anticoagulat Screening program H25LUPUS 2 1

lyophilised plasma from patients with LA and normal plasma

Included Analytes

lyophilised plasma from patients with LA and normal plasma

9

9

9

9

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Rhenium Medical34

Haemophilia Molecular Genetics H25HEMOA 2 Variable Whole blood or lyophilised DNA

Included Analytes Haemophilia Molecular Genetics

TEG / ROTEM H25TEGRA 3 1 x

Included Analytes

ADAMTS13 H25AOAMS 2 1 x

Included Analytes ADAMTS13

Factor XIII assays H25FAC13 2 per year 1 or 2

lyophilised plasma from patients with FXIII deficiency and normal plasma

Included Analytes

Factor XIII assays




Apixaban assays H25APIXA 4 1 x

Included Analytes Apixaban

Dabigratran assays H25DABIG 4 1 x

Included Analytes Dabigratran

Rivaroxaban assays H25RIVAR 4 1 x

Included Analytes Rivaroxaban

Edoxaban assays H25EDOXA 4 1 X

Included Analytes

Plasma Homocysteine H25HOMA 4 1

Human, plasma-pheresed/seperated, lyophilised plasma

Included Analytes Homocysteine

8

8

8

8

8

8

8

8

8

Haematology





Nucleated Red Blood Count H22NRBCA 4 x x

Included Analytes

NRBC

Blood Transfusion Major Exercise H20COMPA 4 9 Human red cells and plasma

Included Analytes

ABO and RhD Grouping Antibody Detection Antibody screening Cross Matching

Blood Transfusion Major & Minor Exercise H20FULLA 10 13 Human red cells

and plasma

Included Analytes

ABO and RhD Grouping Antibody Detection Antibody screening Cross Matching

ABO titration H20TITRA 4 5 Plasma and red cells

Included Analytes ABO titration

Red Cell Genotyping H20REDGE 4 2 Whole blood

Included Analytes

Red Cell Genotyping

Holotranscobalamin H25HOLOT 12 3Serum derived from single patient donations

Included Analytes

Menaquinone-4 H25MENA4 3 2 Spiked serum and ethanolic samples

Included Analytes

MK-4

Menaquinone-7 H25MENA7 3 2 Spiked serum and ethanolic samples

Included Analytes

MK-7

17

17

8

8

9

9

9

9

Rhenium Medical36

Microbiology




General Bacteriology & Antimicrobial susceptibility M17BACTA 12 3 Freeze dried

mixtures of bacteria

Included Analytes

General Bacteriology & Antimicrobial Suspectability

Clostridium difficile M17CDIFA 4 2 Freeze dried mixtures of bacteria

Included Analytes

C. difficile

Blood & Faecal Parasitology M17FPBPA 8 2\3

Formalinised faecal suspensions, methonal fixed faecal smears, fixed urine specimens, formalised cyst fluid

Included Analytes

presence of parasites HIV antibody/antigen

Mycology M17MYCOA 4 4 Freeze dried fungi anda yeasts

Included Analytes

pathogenic fungi Chlamydia infection Chlamydia infection

Community Medicine M17COMMA 4 4 Freeze dried mixtures of bacteria

Included Analytes

Isolation of pathogens from simulated clinical material

Malaria Rapid M17MARAA 2 2 Haemolysate with malarial antigen

Included Analytes

P. falciparum or other malaria species antigens Nucleic acid from all malaria species

11

11

12

11

11

12





Mycobacteria Culture M17MBCUA 3 4 Freeze dried simulated sputum

Included Analytes

Detection of mycobacteria by culture HCV RNA

Parasite Serology M17PARSA 4 6 Human serum

Included Analytes

Schistosoma Amoeba Hydatid Toxocara Strongyloides T. cruzi

Faecal Parasitology M17FPARA 8 2\3

Formalinised faecal suspensions, methonal fixed faecal smears, fixed urine specimens, formalised cyst fluid

Included Analytes

ova cysts larvae Rubella

MRSA Screen M17MRSAA 4 2 Human serum

Included Analytes

Detection of MRSA by culture and/or molecular methods

Hepatitis C serology M17HEPCA 3 6 Human serum

Included Analytes

HCV antibody HCV antigen Flavivirus

Hepatitis B serology M17HEPBA 3 6 Human serum

Included Analytes

HBsAg HB markers (anti-HBc, HBeAg, anti-HBe)

11

12

12

11

11

11

Rhenium Medical38




Microbiology

Hepatitis E Serology M17HEPES 3 4 liquid human serum

Included Analytes

Hepatitis E HIV1/2 antibody/antigen screening

Cryptococcal antigen detection M17CRYPT 3 2human serum, simulated CSF or BAL

Included Analytes

Cryptococcal containing samples

HIV Serology M17HIV1A 3 6 Human serum

Included Analytes

HIV 1 and/or 2 antigen/antibody confirmation

Syphilis Serology M17SYPHA 2 6 Human serum

Included Analytes

treponemal antibodies

Toxoplasma Serology M17TOXOA 4 3 Human serum

Included Analytes

Toxoplasma IgM typing and rifampicin resistance testing) of mycobacteria

Diagnostic serology Hepatitis screen M17HEPSA 2 3 Human serum

Included Analytes

HAV IgM EBV IgM and IgG

Immunity Screen M17IMSCA 2 6 Human serum

Included Analytes

IgG antibodies to hepatitis A IgG antibodies to cytomegalovirus IgG antibodies to varicella zoster virus

HBV DNA quantification

11

11

11

11

11

11

11





Measles & Mumps IgG serology M17MSLGA 2 4 Human serum

Included Analytes

Measles & Mumps

Rubella IgG Serology M17RUBGA 2 6 Human serum

Included Analytes

Rubella IgG

Viral gastroenteritis M17GASTR 2 4 Freeze dried human faeces

Included Analytes

Norovirus Rotavirus Adenovirus

Blood donor Screen M17BLDSC 6 3 Liquid human serum

Included Analytes

HBV surface antigen HBc antibody HCV antigen/antibody HIV antigen/antibody

HTLV I/II antibody Treponemal antibody

Fungal Biomarkers M17GALAC 3 3 Spore suspension

Included Analytes

galactomannan

HIV Point of care SM17HIVPO 4 2 Liquid human serum

Included Analytes

HIV

Genital Pathogens M17GENPA 3 2simulated freeze dried genital clinical specimens

Included Analytes

11

11

11

11

11

11

11

Rhenium Medical40

Viral gastroenteritis M17GASTR 2 4 Freeze dried faeces

Included Analytes

Norovirus Rotavirus Adenovirus 40, 41

Blood Born Viruses M17BBVA 6 3 Human serum

Included Analytes

HBV HCV HIV

Antifungal Susceptibility M17ANTIF 3 2 Spore suspensions

Included Analytes

antifungal susceptibilities in yeasts and filamentous fungi

Molecular Detection of Chlamydia trachomatis & Neisseria gonorrhoea M17CHLAA 3 4

Simulated liquid urine and vaginal swab

Included Analytes

Chlamydia trachomatis Neisseria Gonorrhoea

Malaria (Molecular) M17MARMO 4 4 Lyophilised blood

Included Analytes

Malaria species

Molecular Detection of Mycobacteria M17MYCOM 3 2Freeze dried mixtures of mycobacteria and normal bacterial flora

Included Analytes

Direct Mycobacteria Post Culture Mycobacteria Rifampicin Susceptibility

11

11

11

11

11

11




Microbiology


Hepatitis C (HCV) RNA detection M17HCRDA 3 2 Freeze dried human plasma

Included Analytes

HCV RNA qualitative detection HCV RNA quantification HCV RNA genotyping

Hepatitis B DNA Quantification M17HBQA 2 4 Freeze dried human serum

Included Analytes

HBV DNA quantification

C. trachomatis and N. gonorrhoeae M17TRAGO 3 2 Simulated liquid urine and vaginal swab

Included Analytes

C. trachomatis and N. gonorrhoeae

CMV DNA quantification M17CMVDN 3 2 Freeze dried human plasma

Included Analytes

CMV

EBV DNA quantification M17EBVDN 3 4 Freeze dried human plasma

Included Analytes

EBV

HIV-1 RNA quantification M17HIVRN 3 2 Freeze dried human plasma

Included Analytes

HIV

Molecular detection and resistance testing of Mycobacteria M17RESIS 3 2

Freeze dried simulated sputum and Genotyping results

Included Analytes

Mycobacteria Rifampicin

11

11

11

11

11

11

11




Rhenium Medical42

Molecular detection of HPV M17HPVMU 3 4Endocervical liquid based cytology specimens

Included Analytes

HPV high risk genotypes

Molecular detection of respiratory viruses M17RESPR 3 4

Freeze dried simulated nasopharyngeal aspirate

Included Analytes

Influenza viruses Adenoviruses Respiratory syncytial viruses Rhinoviruses Bocavirus

Enteroviruses Metapneumovirus Parechoviruses Coronaviruses Parainfluenza viruses

Molecular detection of viruses in CSF M17VICSF 2 6Freeze dried simulated cerebrospinal fluid

Included Analytes

HSV-1 DNA HSV-2 DNA VZV DNA Enteroviruses RNA

Hepatitis E RNA Detection M17HEPEM 3 2 Liquid human serum

Included Analytes

HEV RNA

11

11

11

11




Microbiology

Rhenium Medical44




HLA Phenotyping M15HLAPH 5 2

Anticoagulated whole blood diluted in tissue culture medium

Included Analytes

HLA-A HLA-C HLA-B HLA-DR HLA-DQ

HLA-B27 Testing M15HLAB2 5 2


Included Analytes

HLA-B27/B2708/B*27

HLA Antibody Specificity Analysis M15HLASA 2 6


Included Analytes

HLA Antibodies

HLA DNA Typing 1ND Field Resolution M15HLADN 2 5 Anticoagulated whole blood

Included Analytes

DNA HLA HLA-A HLA-B HLA-C HLA-DRB1

HLA-DRB3 HLA-DRB4 HLA-DRB5 DQA1 HLA-DQB1 HLA-DPA1

HLA-Antibody Detection M15HLAAN 2 10Serum samples preserved with sodium azide

Included Analytes

HLA Antibodies

HLA and Disease Typing for HLA-DR/DQ/DP M15HLADI 2 3 DNA preparations

Included Analytes

HLA-DR/DQ/DP


13

13

13

13

13

13





HFE genotype and Hereditary Haemo-chromatosis M15HFE1A 2 2 Clinical scenarios

Included Analytes

h63d (hist63asp) mutation c282y (cys282tyr) mutation c282y (cys282tyr) mutation

Cytotoxic Crossmatching M15CYTOT 5 2 blood + 4 serum

Anticoagulated whole blood diluted in tissue culture medium + serum samples preserved with sodium azide

Included Analytes

Peripheral blood lymphocytes (PBL) and/or T-cells and/or B-cells with and/or without dithiothreitol (DTT) treatment of sera

Crossmatching by Flow Cytometry M15CROSS 5 2 blood + 4 serum

Anticoagulated whole blood diluted in tissue culture medium + serum samples preserved with sodium azide

Included Analytes

Positive/negative activity, crossmatch status

HLA DNA Typing 2ND Field Resolution M15HLAD2 2 5 Anticoagulated whole blood

Included Analytes

DNA HLA HLA-A HLA-B HLA-DRB1 HLA-DRB4

HLA-DRB5 HLA-DQA1 HLA-DQB1 HLA-DPA1 HLA-DRB3 HLA-C

hla-dpb1

ABO DNA Grouping M15ABODN 2 5 Anticoagulated whole blood

Included Analytes

ABO Allele


13

13

13

13

13

Rhenium Medical46





HLA-B57:01 Typing M13HLA57 2 5 Blood samples

Included Analytes

HLA-B*57:01

HLA & Disease Typing for HLA-DR/DQ/DP only M15HLADR 2 5 DNA

Included Analytes

HLA-DR/DQ/DP

KIR Genotyping M15KIRGE 2 5

Included Analytes

Killer-cell immunoglobulin-like receptor genotypes

HPA (Human Platelet Antigen’s) Genotyping M15HPAGE 2 5 Blood samples

Included Analytes

HPA-1 HPA-2 HPA-3 HPA-4 HPA- 5 HPA- 6

HPA- 15

13

13

13

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Rhenium Medical48




Pathology

Cellular Pathology Technique - Neuropathology CC5CPTNU 6 4

Formalin fixed, paraffin sections of (mostly) human tissue

Included Analytes

H&E stained sections

Special stained sections including: swollen axons, myelin, glial fibres, glial fibres, senile plaques, neurofibrillary tangles, nissl. Nb

Cellular Pathology Techniques CC5CPT1Q 6 4


Included Analytes

(H&E) stained sections Special stained

Muscle Histochemistry CC5MHIS1 6 4


Included Analytes

H&E NADH Cytochrome Oxidase Gomori Trichrome

Non Gynecological Diagnostic Cytology CC5NGYNE 4 2-4

Non cytology preparations submitted from participants

Included Analytes

Non gynecological cytology

Renal Biopsy Pathology CC5RENA1 6 4


Included Analytes

H&E Methenamine silver Periodic acid-Scniff EVG

14

14

14

14

14





Transmission Electron Microscopy (TEM) CC5ELECTR 6 N\A Digital image

Included Analytes

Enal biopsies Muscle biopsies Nerve biopsies Respiratory cilia Skin and epithelia samples

Bone Marrow Trephine (BMT) CC5BONEM Cellular elements of the blood

Included Analytes

BMT

Mohs’ Procedure CC5MOH1Q 6 2

H&E stained sections, and / or Tol blue stained sections

Included Analytes

surgical Haematoxylin and Eosin (H&E) stained sections Toluidine Blue (Tol blue) stained sections

General Pathology CC5GEN1A 4 2 Slides

Included Analytes

General Pathology

Breast Pathology (Hormonal Receptors) CC5BREST 4 1 Slides

Included Analytes

Breast Pathology

Breast Pathology (HER-2/neu) CC5HER2 4 2 Slides

Included Analytes

HER-2

14

14

14

14

14

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Rhenium Medical50

Pathology




Lymphoid Pathology CC5LYMPH 4 2 Slides

Included Analytes

Lymphoid

Cytopathology CC5CYTOP 4 2 Slides

Included Analytes

Cytospin preparations or cell block sections

Alimentary Tract Pathology – GIST CC5TRACT 4 2 Slides

Included Analytes

CD117 DOG-1 or CD34 or SMA or Desmin or S100

Alimentary Tract Pathology – Lynch syndrome CC5TRALY 4 2 Slides

Included Analytes

MLH1 & PMS2 OR MSH2 & MSH6

Gastric HER2 CC5HERG 4 2 Slides

Included Analytes

Her2

ALK IHC CC5ALKIH 4 2 Cell lines and tissue samples

Included Analytes

Alk expression

PD-L1 CC5PDL1A 4 2 Cell lines and tissue samples

Included Analytes

PD-L1

14

14

14

14

14

14

14





Gastric HER2 IHC CC5HERI1 4 2 Slides

Included Analytes

Gastric HER2

Breast HER2 ISH (Interpretive & Technical) CC5HEISH 4 2 Slides

Included Analytes

Breast HER2 ISH

Non-Small Cell Lung carcinoma (NSCLC) ALK IHC CC5CARCI 4 2 Slides

Included Analytes

14

14

14

Rhenium Medical52




Andrology

Semen Analysis & Morphology C25SPAMA 4 4

Liquid semen (fixed in 10% formalin)\Online link-Web based in collaboration with Gamete Expert

Included Analytes

Sperm Motility (MOT) Online Sperm Morphology Online Sperm Motility

Sperm Concentration (CON) Sperm Concentration (CON) Sperm Morphology (MOR)

Embryo Morphology C25EMBRA 4 4

Online link-Web based in collaboration with Gamete Expert

Included Analytes

Embryo Morphology

15

15

Rhenium Medical54

Programme name Lab Number password Identity Web site Remarks

Rhenium Medical Ltd. www.rhenium-medical.co.il 20 Hasatat St. P.O.B 180, Modi'in, 7171101, Israel, T 972-8-9558847 T 972-8-9558865 [email protected]

CLINICAL CHEMISTRY www.birminghamquality.org.ukTRACE ELEMENTS www.surreyeqas.org.ukCARDIAC MARKERS www.ukneqas-cm.org.ukGUILDFORD PEPTIDE HORMONES www.surreyeqas.org.ukEDINBURGH PEPTIDE HORMONES www.edqas.orgIMMUNOLOGY, IMMUNOCHEMISTRY & ALLERGY (IIA) www.immqas.org.ukLEUCOCYTE IMMUNOPHENOTYPING www.ukneqasli.co.ukHAEMATOLOGY www.ukneqash.orgBLOOD COAGULATION www.ukneqasbc.orgBLOOD TRANSFUSION LABORATORY PRACTICE www.ukneqasbtlp.orgMICROBIOLOGY www.ukneqasmicro.org.ukPARASITOLOGY www.ukneqasmicro.org.uk/parasitologyHISTOCOMPATIBILITY & IMMUNOGENETICS www.ukneqashandi.org.ukCELLULAR PATHOLOGY TECHNIQUE (CPT) www.ukneqascpt.org.ukREPRODUCTIVE SCIENCE www.mft.nhs.ukDEQAS www.deqas.comKEQAS www.keqas.com

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Rhenium Medical Ltd. 20 Hasatat St. P.O.B 180Modi'in, 7177701, Israel T 972-8-9558847 F 972-8-9558865 [email protected]

external quality assurance catalog 2020

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