Basic Requirements for NABL Accreditation of Biochemistry Laboratory

 

BIOCHEMISTRY LABORATORY

NABL ACCREDITATION BASIC REQUIREMENTS

(Small Sized Laboratory, Less than 100 Patients Per day)

 

1.     Designate/Appointment of Lab Director, Quality Manager, Technical Manager.

2.  Quality Manager should obtain internal Auditor Certification for standard ISO 15189:2012.

3.  Appointment of Authorized Signatory for signing of patient test reports (MD Biochemistry/MD Pathology/ PhD Biochemistry)

4.  Minimum three DMLT / B.Sc (Lifescience - Biochemistry/Biotechnology/Microbiology) qualified staff with experience in biochemistry sample testing & reporting.

5.  Daily minimum 2 Levels of IQC Material Testing before patient sample testing. Records to be maintained.

6.  Deep Freezer (-20 degree Celsius) for storage of reconstituted IQC Materials.

7.  Before submission of NABL Application, At least Two cycles of EQAS participation reports required for the scope of  tests applied. Suggested EQAS program in india are  CMC (Vellore)/RML EQAS/Metropolis EQAS Plus Program/Biorad EQAS/Randox- RIQAS etc.,). https://mindemits.blogspot.com/2021/01/pt-eqa-providers-medical-testing-in.html

8.     Fully Automated Analyser with necessary backup analyser (or) MoU with nearby NABL Accredited lab (with scope of Biochemistry) in case of breakdown/reagent un-availability. Automated Analyser required IQ/OQ/PQ & Calibration Certificate.

9.   Separate Refrigerator for storage of patient samples for 24 hours. 

10.  For All scope of tests required test method verification (at yearly basis) – Precision (Within Day & Between Day) /Accuracy Comparison /Carry-over testing.

11.  Reporting the critical alert results and record the results in critical alert record.

12.  One round of Internal Audit (as per ISO 15189:2012 & NABL 112) & Management Review should be conducted before submitting NABL Application.

13.  Monitor the room temperature & humidity by using Digital Thermo hygrometer.

14.  Reagent Grade Distilled Water for Automated Analyser/QC Reconstitution

    15.  Separate Area for Sample Collection Facility (with privacy & proper arm rest chair for phlebotomy) & Patient Waiting Area.

16.  Equipment Calibration frequency :

• Centrifuges - Every 12 months with NABL Accredited Calibration lab.  
• Micropipettes – Initial manufacturer certificate and calibration checks for every 12 months with NABL Accredited Calibration Service Provider
• Temperature monitoring devices – Every 12 months with NABL Accredited Calibration Service Provider.
• Refrigerator/Freezers - Every 12 months with NABL Accredited Calibration Service Provider
• Automated Analyser – Every 12 months/ Recommended by manufacturer.

17.   Documents/SOPs Requirement.

• Quality Manual (as per ISO 15189:2012) 
• Quality System Procedures (as per ISO 15189:2012) 
• Primary Sample Collection Manual (with addressing Blood sample collection procedure for Biochemistry) 
• Lab Safety Manual 
• Test SOPs for the NABL scope of Accreditation (as per clause 5.5 of ISO 15189:2012) 
• Risk Assessment Report (on annual basis) 
• Quality Indicators Report (on Monthly basis) 
• Laboratory Contingency Plan 
• List of Approved Suppliers & Supplier Evaluation (on annual basis)

 

18. Following are key records with update of minimum of 3 to 6 months patient data.

·         Test Request Form

·         Sample Receiving Record / can be captured in LIS.

·         Sample Rejection Record

·         Analyte Calibration Log

·         IQC Record

·         IQC Corrective Action Record

·         EQAS File

·         Critical Results/Alert Reporting Record

·         Repeat Testing Record

·         Advisory Service Record

·         Revised Reports file

·         Reagent Lot Verification

·         Stock Record

·         Equipment Maintenance Log

·         Daily Temperature Log (Room, Refrigerator, Deep Freezer)

·         Process Non-conformance Record

·         Sample Storage & Discard Record

·         Incident / Accident Record

·    Personal Records (Appointment Letter, Job Description, Educational Certificates, Training record, Competency Evaluation, Vaccination) 

                            .        Record of Customer complaints and Feed backs 

PREPARED BY

V.SELVAM, M.Sc

Mobile : 9940014466

Email : selvamqms@gmail.com

This is my digital business card: https://www.dibiz.com/selvammindemits

 

PT / EQA Providers (Medical Testing) - Details and Registration weblinks, Year 2021

 EQA/PT PROVIDERS (MEDICAL TESTING) - DETAILS/REGISTRATION 2021 - Web links :

(INDIA & INTERNATIONAL PROVIDERS IN INDIA)

CMC EQAS (Vellore) - Biochemistry

Disciplines Scope : Clinical Chemistry, Thyroid Hormones, Cortisol, HbA1c, Reproductive Hormones, Biochemical Markers For Downs Screening , Urine Chemistry,  Tumor Markers

NABL Scope  (ISO 17043) : https://nabl-india.org/nabl/file_download.php?filename=4280.doc

http://home.cmcvellore.ac.in/clinqc/aboutRegistration.aspx

ISHTM CMC EQAS (Vellore) - Haemostasis & Transfusion Medicine

Disciplines Scope : Haemostasis (PT, APTT, TT, Factor VII, Factor IX, VWF:AG,VWF:RCO, Fibrinogen),  Transfusion Medicine (Blood Grouping & Typing, Direct Coombs and Indirect Coombs test, Compatibility test, Antibody Screening , Antibody Identification, Transfusion Transmissible Infections Screen Module (serology – HIV, HBV, HCV, Syphilis and malaria –smear), Donor Haemoglobin Screen

https://www.cmceqas.org/registration.php

CMC EQAS - Microbiology & Virology, Vellore

https://iammeqascmc.org/

http://microbiology.iammeqascmc.org/home/enrolment

http://virology.iammeqascmc.org/credential/register

RML Quality Assurance Program (RML-QAP), Lucknow

Disciplines Scope : Clinical Biochemistry, Immunology, Haematology, Urine Routine Analysis, Histopathology, Cytopathology, Serology, HbA1c

NABL Scope  (ISO 17043) : http://13.127.105.244/nabl/file_download.php?filename=5009.doc

http://www.rmlpathology.com/quality-assurance-program

http://www.rmlpathology.com/theme/web/core/rml/images/document/participant-manual.pdf

ISHTM AIIMS EQAS (New Delhi), Haematology (CBC & PS)

NABL Scope  (ISO 17043) : http://13.127.105.244/nabl/file_download.php?filename=6679.doc

https://www.ishtmaiimseqap.com/assets/front/images/instructions.pdf

https://www.ishtmaiimseqap.com/register

NEUBERG ANAND ACADEMY OF LABORATORY MEDICINE – QUALITY ASSESSMENT PROGRAMME (NeuQAP), Banglore

Disciplines Scope : Biochemistry, Special Chemistry , Hematology , Serology, Extended Serology, ACP , Histopathology , Cytogenetics , immunopathology , HbA1c

NABL Scope  (ISO 17043) : https://nabl-india.org/CertificateFile/PTP.php?appid=MTIzMTE=&check=lbanelif&Phase=MA==

https://www.neu-qap.com/LabRegistration.aspx

BIORAD - EQAS, USA

https://www.qcnet.com/

https://classic.qcnet.com/signUp/addUser.asp?lci=en

RANDOX - RIQAS, United Kingdom

http://riqasconnect.randox.com/riqas/Default.asp

http://riqasconnect.randox.com/riqas/documents/en-inst.pdf

PREPARED BY

Mr.V.SELVAM, M.Sc

Mobile : 9940014466

Email : selvamqms@gmail.com

https://www.dibiz.com/selvammindemits

Molecular Testing Lab - Floor Plan Design (Medical Testing Lab for RT-PCR RNA Virus/ COVID-19) and ICMR Approval Requirements for Covid-19 Testing Lab

ICMR (India) was giving approval for RT-PCR Testing labs for Covid 19 Testing based on NABL Accreditation (for Private Labs) and Personnel & Infrastructure requirements.

NABL launched online portal for "NABL Accreditation for medical testing laboratories of RT-PCR RNA Virus/ COVID-19". Accreditation was being provided  within 10 days of sending online application through online assessment (through Zoom app). Lab needs to get NABL Accredited for any one Infectious RNA Virus - RT PCR Tests (Such as HCV, HIV, Dengue).

Hereby provided basic layout without measurement for molecular testing Lab for RT-PCR Testing of RNA Virus. 

Below provided layout can be used as basic reference for designing the molecular testing lab for medical diagnostics.

Note : For TrueNat or Catridge based PCR Methods, PCR Master mix & Template Addition rooms may not required. However contact the manufacturer representatives before start of infrastructure work for PCR Lab.

Note :  ICMR Providing Expedited Approval ( within 7 days) for Covid 19 Testing based on submitting Lab Details and NABL Application copy For TrueNat or CBNAAT PCR Equipment's. Lab should get NABL Accredited and Scope & Accreditation Certificate copy should be submitted to ICMR within 4 weeks from the date of  Provisional Approval for Covid 19 RT PCR Testing.

Refer : https://www.icmr.gov.in/pdf/covid/labs/Letter_regarding_expedited_TrueNat_CBNAAT.pdf

ICMR  Approval Requirements for Setting up a Real Time PCR Testing Facility for Covid -19

Staff , Equipment and Consumables Requirements 

(Excerpts from "ICMR - Application invited from Govt & Private Medical Colleges for setting up Covid-19 testing facility, date 8.4.2020")

   Ref : https://www.icmr.gov.in/pdf/covid/labs/Invitation_from_Govt_Pvt_Medical_College_COVID19_testingfacility.pdf

Staff Requirements :

    A. Availability of following minimum staff: 

          Medical Microbiologists – 1 or more with experience of work in Molecular                                  Virology. 

           

         Technicians – At least 4-6 (2-3/shift) with relevant experience of work in                                      Molecular Virology.

          

          Multi-Task Staff – 1 or more for washing / cleaning 

    B. Desired expertise of the staff: 

          

         Good understanding of laboratory biosafety and biosecurity, trained for                                     handling respiratory samples for viral diagnosis, RNA extraction and real-time                          PCR.

         Experience of work in virology and handling clinical specimens, especially                                respiratory samples. 

Equipment's : 

• Biosafety cabinet (BSC) class 2A or 2B2 (calibrated)
• -20 °C deep freezer with UPS, for storage of reagents (primers/ probes/ positive controls) 
• -80°C deep freezer with UPS, for storage of aliquoted samples/ viral RNA in cryovials 
• 4°C refrigerator (for storage of viral transport medium, and for short term storage of samples and extracted RNA)
• UPS (2 nos., 2KVA each, with 2 hours back-up, for real time PCR instrument and nucleic acid extraction systems – if not available, then to be carried);  and confirm about power backup for the two deep freezers (check about duration of power outages, if any)
• Real-time PCR machine 
• Microcentrifuge / Refrigerated Centrifuge

Consumables :

• For sample collection:  

               a. Personal protective equipment (PPE) 

               b. Viral Transport Medium (VTM) 

               c. Flocked Dacron swabs (2 swabs/ sample collection from 1 patient

• During Processing:  

           a. Biosafety cabinet class IIA/ IIB 

           b. Personal protective equipment:  N95 masks, coveralls (protective                                               against blood and body fluids), nitrile gloves, shoe cover, head cover 

           c. Vortex mixer 

           d. Microcentrifuge (Cold centrifuge)

           e. Cryovials (2 ml)  

           f. Cryobox 

           g.Pipette aid 

           h.Disposable plastic pipettes 

           i. Sprit lamp 

           j. Forceps (if no spirit lamp, then disposable forceps for each sample) 

           k. 70 % ethanol (also required for next stage, i.e., extraction)

           l. 1% sodium hypochlorite (4% stock, to be freshly reconstituted daily to 1% with  water)                     

           m. Discarding jars 

           n. Biomedical waste disposal (BMW) bags (with ties for sealing; preferably                                     autoclavable, if discarding autoclave is available/ used locally) and bins 

           o. Iceboxes with gel packs or regular ice supply in laboratory (from                                                  icemaker) 

           p. Tube rack (15 ml tubes) 

           q. For tube / cryovial labelling - Marker pens, cellotape, or label printouts                                       (printer with label maker)

Nucleic Acid Extraction 

• Manual extraction using kits for Viral RNA extraction: Viral RNA mini kits (Qiagen) or other viral RNA extraction kits for manual extraction  
• 1.7 ml Eppendorf tubes (separate ones also required for next step) 
• Cryovial/ Eppendorf tube rack (separate ones also required for next step) 
• Microcentrifuge (small equipment) 
• Micropipettes- 100-1000ul, 20-200ul (additional separate micropipettes of required volumes also listed for next stage, i.e. real time PCR) 
• Filter barrier tips: 1000ul, 200ul 
• Tissue rolls 
• Hand sanitizers 
• Biohazard labels 

 Real Time PCR

• Real time PCR machine (open system) – calibrated for the fluorophore dyes which are present on the probes .

• Reagents for setting up Real-time

           PCR primers and probes specific for SARS-CoV2 targets 

           PCR master mix reagents (e.g., Thermo Fisher/ Invitrogen AgPath/ Superscript III Platinum real time PCR reagents) with buffer and enzyme                         

• PCR Reagents

             Primers for E gene screening and  

             Probes for E gene screening and RDRP/ ORF 1b targets 

             PCR Buffer and enzyme mix  o Positive contro

•  PCR workstations – 1 for mastermix preparation; 1 for RNA addition 
•  Cryovial racks 
•  PCR tubes/ PCR plates 
•  PCR plate adhesive seals and plate sealer 
•  Micropipettes- 0.5-10ul (2 nos., 1 for PCR master mix and 1 for RNA addition), 2-20ul,20-200ul 
•  Filter barrier tips – 10ul, 20ul, 200ul 
•  Microspin (small equipment) 
•  Plate centrifuge (small equipment) 
•  Electronic micropipette (optional small equipment, but convenient and reduces time duration of testing) 
•  Nuclease free water - for PCR 
•  RNaseP 

NABL Guidelines for Storage of Molecular Testing Specimens :

(NABL 112 Guideline, Issue 4, Issue Date 11.2.2019)

Test/Sample	Minimum Retention  Period & Storage Conditions
DNA	5 Years at -20°C 2 Years at -20°C for infectious disease molecular Testing
Extracted RNA	5 Years at -70°C 2 Years at -70°C for infectious disease molecular Testing

Source Reference :

1. https://www.icmr.gov.in/ctestlab.html

2. https://nabl-india.org/

3. https://apps.who.int/iris/handle/10665/249549

POSTED BY: 

Mr.V.SELVAM, M.Sc (Biochemistry)

Consultant - ISO 9001 & NABL (ISO 15189 & ISO 17025)

MindEmits Consulting Services, 

Chennai, Tamilnadu, India

✆ +91-9940014466

☭  selvam.mindemits@gmail.com

🌐 www.mindemits.in

QC Rejection Rules (Westagard Rules) in Simplified Table

Internal quality control results are monitored by using Levy Jennings Chart (LJ Chart / Control chart) with applicable westgard rules.  Herewith i provided the five basic  westgard rules in simplified table to make decision on Accepting/Rejecting the QC run. 

Laboratory professionals can download the below  table (download link provided) and displayed as poster in respective lab sections for easy reference.

DOWNLOAD THE POSTER  

When a rule is violated :

Warning Rule = use another rules to inspect the control points

Rejection Rule = "Out of Control"

• Stop Testing
• Search for recent events that could have caused changes
• Examine environmental conditions.
• Identify and correct problem
• Repeat  testing on patient samples and controls
• Follow manufacturer’s troubleshooting guide
• Refer to instructions of manufacturers of equipment, reagents or QC / calibrator
• Do not report patient samples until problem is solved and controls indicate  proper performance

Points of QC Failures : 

• Instrument Failure:  
• Check for error messages (printed or displayed). 
• Refer to the troubleshooting section of the instrument manual. 
• Reagent, Quality Control Materials, Calibrators: 
• In correct reconstitution, i.e. wrong or contaminated diluent or use of the wrong volume of diluent. 
• In correct storage, e.g. left at room temperature for excessive amount of time. – Prepare fresh (allow enough time to dissolve) 
• NOTE: Bulk liquid reagents may be contaminated. 
• Human: 
• Reread the method 
• Check whether the correct sample volumes or reagents were used.
•  Make sure that a step in the procedure was not missed. 
• Were the correct parameters entered?

Source Reference :
https://www.westgard.com/mltirule.htm

NABL 112 -Specific Criteria for Accreditation of Medical Laboratories  ( Issue - 4, Issue date -11-Feb-2019 )
https://www.aacb.asn.au/documents/item/3078 (Troubleshooting Failed QC, by Dr Douglas Chesher)

POSTED BY: 

Mr.V.SELVAM, M.Sc (Biochemistry)

Consultant - ISO 9001 & NABL (ISO 15189 & ISO 17025)

MindEmits Consulting Services, 

Chennai, Tamilnadu, India

✆ +91-9940014466

☭  selvam.mindemits@gmail.com

Biorad & Randox - QC Product Comparison Review (Lyophilized Clinical Chemistry Control)

Biorad(USA) & Randox (UK) QC are preferred third party Internal Quality Control (IQC) materials in worldwide. They are major key players in the global IVD quality control market. Herewith provided comparison review of Lyophilized Clinical Chemistry Control Material based on product details & kit literature published in their webportal.

The comparison will be useful for Lab Directors,Clinical Biochemists,Medical Biochemists & Medical laboratory professionals to choose easily their QC materials according to Equipment & Test Scope.

S.No	Particulars	Biorad (USA)	Randox (UK)
1.	Product Name	Lyphochek - Assayed Chemistry Control	Acusera – Assayed Chemistry Premium Plus Control
2.	Product Code	Level 1 : C-310-5 Level 2 : C-315-5 Bilevel MiniPak : 313X	Level 2 : HN1530 Level 3 : HE1532 Level 2 & Level 3 : HS2611
3.	Matrix Type	Human Serum , Lyophilized	Human Serum, Lyophilized
4.	QC Levels	Level 1 (Normal), Level 2 (Abnormal)	Level 2 (Normal), Level 3 (High)
5.	Available Pack Sizes	12 × 5 mL – Level 1 12 × 5 mL – Level 2 02 × 5 mL – Level 1 & Level 2	20× 5 mL – Level 2 20× 5 mL – Level 3 2× 5×5 mL – Level 2 & Level 3
6.	Shelf life	3 Years	4 Years
7.	Reconstituted Stability @ 15ºC	Not Provided	8 hours
8.	Reconstituted Stability @ Refrigeration (2-8 ºC)	7 Days  Except : - T3 (Free), Acid Phosphatase (Total) and Prostatic Acid Phosphatase (PAP) – 3 Days	7 Days  Except: - Bilirubin & Total PSA – 4 days - NEFA – 1 day
9.	Reconstituted Stability @ Frozen (-10 to - 20ºC)	30 Days  Except : - Tobramycin : 20 Days - T3 (Free) : 10 Days	28 Days  Note : After stabilization Total and Prostatic Acid Phosphatase is stable for 2 hours at +15°C to +25°C, 2 days at +2°C to +8°C, and 28 days when frozen once at –18°C to –24°C.
10.	Reconstituting Material	Distilled Water	Distilled Water
11.	QC Target/Range	+/- 3 SD	+/- 2SD
12.	Total No of Analytes	80 Analytes	70 Analytes
S.No	ANALYTES LIST	Biorad (USA) Lyphochek - Assayed Chemistry Control	Randox (UK) Acusera –  Assayed Chemistry Premium Plus Control
1.	Alpha-1-Antitrypsin	✓	✘
2.	Alpha-1-Globulin (Electrophoresis)	✘	✓
3.	Alpha-2-Globulin (Electrophoresis)	✘	✓
4.	Alpha-Hydroxybutyrate Dehydrogenase (αHBDH)	✓	✓
5.	Acetaminophen	✓
6.	Acid Phosphatase (Total)	✓	✓
7.	Acid Phosphatase (Prostatic)	✘	✓
8.	Acid Phosphatase (Non-Prostatic)	✘	✓
9.	Alphafetoprotein (AFP)	✓	✘
10.	Albumin	✓	✓
11.	Albumin (Electrohoresis)	✘	✓
12.	Alkaline Phosphatase (ALP)	✓	✓
13.	ALT/SGPT	✓	✓
14.	Amylase	✓	✓
15.	Amylase (Alpha)	✓	✘
16.	Amylase (Pancreatic)	✓	✓
17.	Apolipoprotein A-1	✓	✓
18.	Apolipoprotein B	✓	✓
19.	AST/SGOT	✓	✓
20.	Beta-1-Globulin (Electrophoresis)	✘	✓
21.	Bile Acids	✘	✓
22.	Bilirubin (Direct)	✓	✓
23.	Bilirubin (Indirect) Bilirubin (Total)	✓	✓
24.	Calcium	✓	✓
25.	Calcium (Ionized)	✓	✘
26.	Carbamazepine	✓	✘
27.	CEA	✓	✘
28.	Ceruloplasmin	✓	✘
29.	Chloride	✓	✓
30.	Cholesterol (HDL)	✓	✓
31.	Cholesterol (LDL)	✓	✘
32.	Cholesterol (Total)	✓	✓
33.	Cholinesterase	✓	✓
34.	CO2	✓	✓
35.	Complement C3	✓	✘
36.	Complement C4	✓*	✘
37.	Copper	✓	✓
38.	Cortisol	✓	✓
39.	Creatine Kinase (CK)	✓	✓
40.	Creatinine	✓	✓
41.	D-3-Hydroxybutyrate	✘	✓
42.	Digoxin	✓	✓
43.	Folate	✘	✓
44.	Gentamicin	✓	✓
45.	GGT	✓	✓
46.	GLDH	✓	✓
47.	Globulin	✓	✘
48.	Gamma-Globulin (Electrophoresis)	✘	✓
49.	Glucose	✓	✓
50.	Haptoglobin	✓	✘
51.	hCG-β Subunit	✓	✘
52.	Immunoglobulin A (IgA)	✓	✓
53.	Immunoglobulin G (IgG)	✓	✓
54.	Immunoglobulin M (IgM)	✓	✓
55.	Iron	✓	✓
56.	Iron (UIBC)	✓	✘
57.	Lactate (Lactic Acid)	✓	✓
58.	LAP-Arylamidase	✓	✓
59.	LDH	✓	✓
60.	Lipase	✓	✓
61.	Lithium	✓	✓
62.	Magnesium	✓	✓
63.	NEFA	✘	✓
64.	Osmolality	✓	✓
65.	Paracetamol	✘	✓
66.	PAP	✓	✘
67.	Phenobarbital	✓	✘
68.	Phenytoin	✓	✘
69.	Phosphorus	✓	✓
70.	Potassium	✓	✓
71.	Protein Electrophoresis	✓	✘
72.	Protein Total	✘	✓
73.	Protein (Total) PSA	✓	✓
74.	Salicylate	✓	✓
75.	Sodium	✓	✓
76.	T3 (Free)	✓	✘
77.	T3 (Total)	✓	✓
78.	T3 Uptake/T-Uptake	✓	✘
79.	T4 (Free)	✓	✓
80.	T4 (Total)	✓	✓
81.	TBG	✓	✘
82.	Theophylline	✓	✓
83.	Tobramycin	✓	✓
84.	Transferrin	✓	✓
85.	Triglycerides	✓	✓
86.	Thyroid Stimulating Hormone (TSH)	✓	✓
87.	TIBC	✘	✓
88.	Urea	✓	✓
89.	Urea Nitrogen	✓	✘
90.	Uric Acid	✓	✓
91.	Valproic Acid	✓	✘
92.	Vancomycin	✓	✘
93.	Vitamin B12	✓	✓
94.	Zinc	✓	✓
		Note :  * No Claim is made for expected value or stability
S.No	INSTRUMENTS LIST	Biorad (USA) Lyphochek -  Assayed Chemistry Control	Randox (UK) Acusera –  Assayed Chemistry Premium Plus Control
1.	ABAXIS-PICCOLO	✓	✘
2.	ABX PENTRA 400	✘	✓
3.	ABBOTT ARCHITECT cSYSTEMS	✓	✓
4.	BECKMAN COULTER ACCESS / 2 / 2i	✓	✘
5.	BECKMAN COULTER AU SYSTEMS	✓	✓
6.	BECKMAN COULTER SYNCRON/UniCel DxC SERIES	✓	✓
7.	BIOSYSTEMS A15	✘	✓
8.	BIOSYSTEMS A25	✘	✓
9.	BIOTECHNICA/WIENER BT & CB SERIES	✘	✓
10.	ELITECH/VITALAB SELECTRA SERIES	✘	✓
11.	ILAB 600 /650 /ARIES/TAURUS	✘	✓
12.	KONELAB 20/30/60/THERMO SCIENTIFIC INDIKO PLUS	✘	✓
13.	MINDRAY BS-200/300/400	✘	✓
14.	ORTHO VITROS SERIES	✓	✓
15.	ROCHE / HITACHI COBAS C SYSTEMS	✓	✓
16.	ROCHE COBAS INTEGRA	✓	✓
17.	RANDOX RX SERIES	✘	✓
18.	SIEMENS ADVIA CENTAUR CP	✓	✘
19.	SIEMENS ADVIA CENTAUR SYSTEMS	✓	✘
20.	SIEMENS ADVIA CHEMISTRY SYSTEMS	✓	✓
21.	SIEMENS ATELLICA CHEMISTRY SYSTEMS	✘	✓
22.	SIEMENS BN SERIES NEPHELOMETERS	✓	✘
23.	SIEMENS DIMENSION SERIES	✓	✓
24.	SIEMENS DIMENSION VISTA SYSTEMS	✓	✓
25.	SIEMENS IMMULITE / IMMULITE 1000	✓	✘
26.	SIEMENS IMMULITE 2000 / 2000 XPi	✓	✘
		Note: Target Values can be obtained from “Method List” for Equipment not listed.	Note: Target Values can be obtained from “Mean of All Instruments” for Equipment not listed.

Source Reference :
https://www.bio-rad.com/
https://www.randox.com/

POSTED BY: 

Mr.V.SELVAM, M.Sc (Biochemistry)

Consultant - ISO 9001 & NABL (ISO 15189 & ISO 17025)

MindEmits Consulting Services, 

Chennai, Tamilnadu, India

✆ +91-9940014466

☭  selvam.mindemits@gmail.com