Accreditation No: ML 001. Armed Forces Institute of Pathology (AFIP), Rawalpindi, Pakistan.

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1 Issue : 02/05/12 Accreditation No: Awarded to Armed Forces Institute of Pathology (AFIP), Rawalpindi, Pakistan. The scope of accreditation is in accordance with the standard specifications outlined in the following page(s) of this document. The accredited scope shall be visible and legible in areas such as customer service, sample-receiving section etc and shall not mislead its users. The accreditation was first time granted on by Pakistan National Accreditation Council. The laboratory complies with the requirements of ISO 15189:2012. The accreditation requires regular surveillance, and is valid until The decision of accreditation made by Pakistan National Accreditation Council implies that the organization has been found to fulfill the requirements for accreditation within the scope. The organization however, itself is responsible for the results of performed measurements/tests. PAKISTAN TIO ACCREDITATION COUNCI General Page 1 of 11

2 Issue : 02/05/12 Medical aboratory. Accreditation Scope of Armed Forces Institute of Pathology (AFIP), Rawalpindi, Pakistan. Permanent laboratory premises X Field of Medical Testing aboratory: Sample Type/ Matrix Chemical Pathology Types of test/ Properties measured Range of measurement Minimum detection limit Uncertainty of Measurement (where ) MU (±) Standard specification/ Techniques/ equipment used 1. Plasma Glucose Glucose Hexokinase/ Modular P Serum Urea Urea Urease with GDG / Serum Creatinine Creatinine µmol/l 8.8 µmol/l Jaffe Kinetic / Serum Alanine Aminotransf erase AT U/l 0.5 U/ Enz Kinetic / Serum Bilirubin Bilirubin µmol/l 2 µmol/l Vanadate oxidation / 1800

3 Issue : 02/05/12 6. Serum Albumin Albumin g/l 2 g/l Bromocresol Green / Serum Alkaline Phosphatase AP U/l 0.67 µ Kat/l AMP/ Serum Protein Protein g/l 2 g/l 4.7% Biuret Reaction/ Modular P Serum Calcium Calcium % Arzenao III / Modular P Serum actate Dehydrogena se 11. Serum Gamma Glutamyl Transferase DH Gamma Glutamyl Transferase U/ 6 U/ 3 U/ 9.2% 9.2% Modular P 800 gamma glut- 3-carb-4 nitraonilide / serum sodium sodium mmol/ ISE/ Cobass serum potassium Potassium mmol/ ISE/ Cobass serum cholesterol Cholesterol % Oxidase/ Modular P 800

4 Issue : 02/05/12 15.Serum HD cholesterol HD % Direct HD Roch 3rd gen / Serum magnesium magnesium % Xylidyl Blue/ serum phosphate Phosphate % Phosphomoly date UV/ Serum triglycerides Triglycerides µmol/l 5.6% ipase/gpo- PAP/ Modular P Serum uric acid 20.Serum aspartate aminotransf erase 21.serum creatine kinase Uric acid Aspartate Amino Transferase Creatine Kinase µmol/l U/ U/ 11.9 µmol/l 4 U/ 7 U/l 5.6% 5.6% 5.6% Uricase perox/ 1800 Tris buffer no P5P,IFCC/ Modular P 800 CK-C/ Serum Glycosylate d Haemoglobi n HbA1C % 2.9% 5.6% Immunoturbid ity / 1800 Endocrinology FT4 T3 T4 Triidothyroni ne pmol/ nmol/ 1.3 pmol/ 0.15nmol/ ±3.22% ±0.68%

5 Issue : 02/05/12 TSH FSH H Prolactin Progesteron e Testosteron e Estradiol Ferritin Cortisol Growth Hormone PTH Thyroid stimulating hormone Follicular stimulating homone ueitiizing homone Prolactin Progesterone Testosterone Estradiol Ferritin Cortisol Growth Hormone PTH miu/ miu/ml miu/ml mi U/ nmol/ nmol/ pmol/ ng/ml nmol/l ng/ml pg/ml 0.008mIU / 0.3mIU/m l 0.07mIU/ ml 6.4mIU/ 0.67nmol/ 0.35nmol/ mol/ 0.5ng/ml 5.5nmol/l 0.01 ng/ml 3 pg/ml ±1.92% ±3.5% ±3.3% ±7.42% ±3.7% ±1.32% ±15.48% ±10.22% ±9.24% ±92.24 ±3.19

6 Issue : 02/05/12 Tumor marker Serum AFP BhCG Folic acid AFP BhCG Folic acid IU /ml miu/ml nmol/l 1.08 miu/ml 2 nmol/l 0.79 IU/ml ± 6.2% ± 12.5% ± 4.3% Immulite 2000 CA 125 CA IU/ml 2 ng/ml ± 4.3% CEA CEA ng/ml 0.5 ng/ml ± 3.2% Immulite 2000 PSA PSA ng/ml 0.01nmol/ ± 1.1% Vitamin D Vitamin D nmol/ 10 nmol/l ± 9.9%

7 Issue : 02/05/12 Toxicology & TDM Serum 1.Valproic Acid 2.Carbamaz epine 3.Phenytoin 4.Digoxin ug/ml ug/ml ug/ml ng/ml 2.0 ug/ml 0.2 ug/ml 0.5 ug/ml 0.1 ng/ml ± 6% ± 8.5 % ± 6.2 % ± 8.6% Immulite 1000 Solid phase competitive chemilumines cent enzyme immunoassay (Valproic Acid, Carbamazepin e, Phenytoin & Digoxin) IMMUNOOGY Serum 1. Anti nuclear antibodies 2. Anti double stranded D antibodies Negative Po sitive Negative Po sitive Indirect immunofluore scence Indirect immunofluore scence RA factor (serum) Positive/Nega tive Ref range: ess than 8 IU/ml (Negative) 8 IU/ml atex agglutination CRP (serum) ess than 6 mg/l Ref range: ess than 6 mg/l 6 mg/l - 1.atex agglutination 2. scence

8 Issue : 02/05/12 Anti glomerular basement membrane (GBM) antibodies Positive/Nega tive Positive/Nega tive Cut off According to EISA kit in use Compared to positive control According to EISA kit in use Indirect immunofluore scence EISA Monoclonal paraprotein Present/Absen t Immunfixatio n Immunoelectr ophoresis Histopathology Tissue biopsy material H & E Staining Periodic Acid Schiff (PAS) stain - 1- Trimming Path Hood (Bio Optica) 2- Tissue Tek VIP-5 Processor Tissue Tek VIP-5 Processor Tissue Tek Embedding Console System-1

9 Issue : 02/05/12 MICROBIOO GY 1. Urine Protein Glucose Trace to 10g/ Mmol/ 0.2 mg/dl 5.5 mmol/ Cyberow Reader 720 Urobilinogen umol/ 16umol/ Bilirubin + to PH Nitrite 5-9 Neg to Pos 5 ab kit 2. Serum 3. Serum 4. Bacterial cultures Ketones RPR TPHA Gram Stain mmol/ Pos/Neg 0.5mmol/ OMEGA Gram stain Bacteriuri Strip 5. Urine C/S Pregnancy IU/ ICFU 200 IU/ ab kit Stool Occult blood Parasite/ova /cyst detection STANBIO ABS USA

10 Issue : 02/05/12 Serum H. pylori Antibody OMEGA Bacterial cultures Throat culture Disk Diffusion Genital culture Fungal Culture KOH slides VIROOG Y 1. Serum Sample 2. Serum Sample HBAs Ag Anti HCV Standard Company kit used Standard Company kit used 3. Serum Sample Anti HIV Standard Company kit used

11 Issue : 02/05/12 Haematolo gy EDTA Blood Tri sodium citrate blood Hb Hct RBC count WBC count Platelet Count PT APTT 1-25g/dl 10-60% X10 12 /1 1-99x10 9 / x10 9 / s s 1g/dl 10% 0.30x10 9 / 1 1.0x10 9 /1 10x10 9 /1 10 s 25 s ± 1% ± 3.5% 0.30x10 9 /1 ±0.2x10 9 /1 ±10x109 /1 + 5% + 5% System Kx21 Photometric measurement of Hb by Sodium lowrile sulphate (SS) method. (Stromatolyze r WH) Impediecne method; (Direct Current) DC method. Stago Equipment/ Manual EDT A Blood Tests based on PT & APTT: Factors assays Mixing studies Hb studies HbA HbF HbA2 % >50% correction 1-100% 1-100% 1-8% 1% 5-10% Cellulose acetate electophoresis