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Full Scope of Accreditation
CRYSTAL DIAGNOSTIC PVT. LTD.
Certificate No: NAF/SCH/MLB/2025/01
Accreditation Standard: ISO 15189:2022
Initial Date of Accreditation: 2025/05/22
Expiry Date: 2027/05/21
Legal Entity Name: CRYSTAL DIAGNOSTIC PVT. LTD.
Physical Address: Crystal Complex, Sinamangal-09, Kathmandu, Nepal
Contact: Tel: +977-9802301020 | Email: info@crystaldiagnosticlab.com | Website: https://crystaldiagnosticlab.com
Accredited Scope: Clinical Biochemistry
| Sl. No. | Materials or Products tested | Component, parameter or characteristic tested / Specific Test Performed | Test Method Specification against which tests are performed and/or the techniques/equipment used | Range of testing/Limit of detection | Unit |
|---|---|---|---|---|---|
| 1 | Serum | Albumin | (BCG) | 2-6 | g/dl |
| 2 | Serum | Alkaline Phosphatase (ALP) | IFCC AMP buffer | 5-1500 | U/L |
| 3 | Serum | Alanine Aminotransferase (ALT) | IFCC with Pyridoxal Phosphate | 3-500 | U/L |
| 4 | Serum | Aspartate Aminotransferase (AST) | IFCC with Pyridoxal Phosphate | 3-1000 | U/L |
| 5 | Serum | Total Bilirubin | DPD | 0-30 | mg/dl |
| 6 | Serum | Direct Bilirubin | DPD | 0-10 | mg/dl |
| 7 | Serum | Calcium | Arsenazo III | 4-20 | mg/dl |
| 8 | Serum | Cholesterol | CHO-POD | 4-20 | mg/dl |
| 9 | Serum | Creatinine | Jaffe IDMS Traceable | 0-25 | mg/dl |
| 10 | Serum | GGT | IFCC | 5-1200 | U/L |
| 11 | Serum | Glucose | HK G6P-DH | 11-810 | mg/dl |
| 12 | Serum | LDH | IFCC | 25-399 | mg/dl |
| 13 | Serum | Iron | TPTZ | 11-1000 | ug/dl |
| 14 | Serum | UIBC | Nitroso-PSAP | 56-229 | ug/dl |
| 15 | Serum | Triglyceride | GPO-POD | 9-1000 | mg/dl |
| 16 | Serum | Total Protein | Biuret | 3-12 | g/dl |
| 17 | Serum | Urea | GLDH | 5-300 | mg/dl |
| 18 | Serum | Uric Acid | Uricase PAP | 1-30 | mg/dl |
| 19 | Serum | Magnesium | Xylidyl Blue | 0-8 | mg/dl |
| 20 | Serum | Phosphorus | Molybdate | 1-20 | mg/dl |
| 21 | Serum | Lipase | Colorimetric | 3-600 | U/L |
| 22 | Serum | Amylase | IFCC-EPS | 10-2000 | U/L |
| 23 | Serum | CK(NAC) | IFCC | 10-2000 | U/L |
| 24 | Serum | HDL-C | Enzymatic Immunoinhibition | 2-180 | mg/dl |
| 25 | Serum | LDL-C | Enzymatic Selective Protection | 10-399 | mg/dl |
| 26 | Serum | Sodium | ISE-Indirect | 20-250 | mmol/L |
| 27 | Serum | Potassium | ISE-Indirect | 0.2-40 | mmol/L |
| 28 | Serum | FT3 | CLIA | 0.2-50.0 | pg/ml |
| 29 | Serum | FT4 | CLIA | 0.2-50.0 | ng/dl |
| 30 | Serum | TSH | CLIA | 0.001-100.0 | ulU/ml |
| 31 | Serum | VIT-B12 | CLIA | 12.50-2000.0 | ng/ml |
| 32 | Serum | VIT-D | CLIA | 0.05-150.0 | pg/ml |
| 33 | Whole Blood | HBA1C | HPLC | 3.9-18.8 | % |
Accredited Scope: Haematology and Immunohematology
| Sl. No. | Materials or Products tested | Component, parameter or characteristic tested / Specific Test Performed | Test Method Specification against which tests are performed and/or the techniques/equipment used | Range of testing/Limit of detection | Unit |
|---|---|---|---|---|---|
| 1 | Whole Blood | RBC | Electrical Impedence | 0.20 to 8.00 | 10^6/UL |
| 2 | Whole Blood | HBG | Photometry CMG | 0.20 to 25.00 | g/dL |
| 3 | Whole Blood | HCT | Calculated | 0.0 to 85.0 | % |
| 4 | Whole Blood | MCV | Derived from RBC Histogram | 50.0 to 150.0 | fL |
| 5 | Whole Blood | MCH | Calculated | 0.0 to 99.9 | pg |
| 6 | Whole Blood | MCHC | Calculated | 0.0 to 99.9 | g/dL |
| 7 | Whole Blood | RDW-CV | Derived from RBC Histogram | 10.0 to 40.0 | % |
| 8 | Whole Blood | RDW-SD | Derived from RBC Histogram | 15.0 to 150.0 | fL |
| 9 | Whole Blood | PLT | Electrical Impedence | 7.0 to 2000.0 | 10^3/UL |
| 10 | Whole Blood | MPV | Derived from PLT Histogram | 5.00 to 25.00 | fL |
| 11 | Whole Blood | WBC-D | Electrical Impedence | 0.20 to 100.00 | 10^3/ul |
| 12 | Whole Blood | LYMP% | Optical/Impedence | 0.00 to 100.00 | % |
| 13 | Whole Blood | ΜΟΝΟ% | Optical/Impedence | 0.00 to 100.00 | % |
| 14 | Whole Blood | NEU% | Optical/Impedence | 0.00 to 100.00 | % |
| 15 | Whole Blood | EOS% | Optical/Impedence | 0.00 to 100.00 | % |
| 16 | Whole Blood | BASO% | Optical/Impedence | 0.00 to 100.00 | % |
| 17 | Whole Blood | Lymph# | Calculated | 0.00 to 100.00 | 10^3/ul |
| 18 | Whole Blood | ΜΟΝΟ# | Calculated | 0.00 to 100.00 | 10^3/ul |
| 19 | Whole Blood | NEUT# | Calculated | 0.00 to 100.00 | 10^3/ul |
| 20 | Whole Blood | EOS# | Calculated | 0.00 to 100.00 | 10^3/ul |
| 21 | Whole Blood | BASO# | Calculated | 0.00 to 100.00 | 10^3/ul |
Accredited Scope: Microbiology and Serology
| Sl. No. | Materials or Products tested | Component, parameter or characteristic tested / Specific Test Performed | Test Method Specification against which tests are performed and/or the techniques/equipment used | Range of testing/Limit of detection | Unit |
|---|---|---|---|---|---|
| 1 | Serum | ASO Test (Qualitative) | Latex Agglutination | N/A | N/A |
| 2 | Serum | CRP Test (Qualitative) | Latex Agglutination | N/A | N/A |
| 3 | Serum | RAF Test (Qualitative) | Latex Agglutination | N/A | N/A |
| 4 | Serum | RPR Test (Qualitative) | Flocculation | N/A | N/A |
| 5 | Serum | TPHA Test (Qualitative) | Hemagglutination | N/A | N/A |
| 6 | Serum | FDP Test (Qualitative) | Latex Agglutination | N/A | N/A |
| 7 | Serum | WIDAL Test (Qualitative) | Latex Agglutination | N/A | N/A |
| 8 | Serum | ENA PROFILE | Immunoblot method | N/A | N/A |
| 9 | Serum | ANA PROFILE | Immunoblot method | N/A | N/A |
| 10 | Serum | C-ANCA/P-ANCA/GBM | Immunoblot method | N/A | N/A |
| 11 | Stool | Occult Blood Test | Guaiac Method | N/A | N/A |
For the most current details, please refer to the official certificate and annexure issued by NAF.