Laboratory Correlations and Principles

Quality Control in the laboratory

involve the systematic monitoring of analytic processes in order to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results

Quality Control results

are used to validate whether the instrument is operating within pre-defined specifications, inferring that patient test results are reliable. Once the test system is validated, patient results can then be used for diagnosis, prognosis, or treatment planning.

quality control product

is a patient-like material ideally made from human serum, urine or spinal fluid.

control product

can be a liquid or freeze-dried material and is composed of one or more constituents of known concentration.

5mL

amount of distilled water used to reconstitute lyophilized controls.

30 minutes

how long should you stand the prepared control

500 ul

amount of control samples should be used

15 days

controls are stable for ___ and are thawed only when needed

8 hours

thawed controls are only stable for

Levey

intra-laboratory quality control was established by

precision assessment

intra-laboratory quality control primarily monitors the day-to-day performance of laboratory tests

1. run a minimum of two levels of controls

2. run internal quality controls at least once during each-user defined analytical run length.

good internal quality control practice

CLSI Guidelines C24-A3, Section 6.2.2

guidelines: run a minimum of two levels of controls

CLSI C24-A3, Section 7,7.1 and 7.2

guidelines: Run internal quality controls at least once during each user-defined analytical run length

at least once a day

application of two level QCs when the sample is <50-100/day

at least twice a day

application of two level QCs when the sample s >100 samples/day

establish own QC range

at least 20mmeasurements should be made on “separate” days when the measurement system is known to be stale based on Qc results of existing lots be used to establish laboratory target values for control materials.

Levey-Jennings Chart

a graphical method for displaying control results and evaluating whether a procedure is in-control or out of control

Monitoring

purpose of L-J chart is to evaluate the precision and accuracy of repeated measurements.

Reviewing

purpose of L-J chart is to take necessary action and document

Gaussian distribution

in order to evaluate that the analytical process is in control, the QC will fall in

99.7%

gaussian distribution within +3SD

95.5%

gaussian distribution within +2SD

68.2%

gaussian distribution within +1SD

inter-laboratory quality control

quality control that is established by Belk which monitors and evaluates work made by an external system/institution/organization with specimens that has the content or concentration of which is known or unknown in order to ensure or improve the reliability of laboratory test results

Belk

external quality control was established by

Youden plots

external quality control makes use of

East Avenue Medical Center

NRL for Environmental & Occupational Health

East Avenue Medical Center

NRL for Toxicology

East Avenue Medical Center

NRL for Micronutrient Assay

East Avenue Medical Center

NRL for Industrial and Chemical Emergencies

Lung Center of Philippines

NRL for General Clinical Chemistry

Lung Center of Philippines

NRL for Anatomic Pathology for Pulmonary and Pleural Diseases

National Kidney Transplant Institute

NRL for Hematology

National Kidney and Transplant Institute

NRL for Immunohematology

National Kidney and Transplant Institute

NRL for Urinalysis

National Kidney and Transplant Institute

NRL for Anatomic Pathology for Renal Diseases and other Unassigned Organ Systems

National Kidney and Transplant Institute

NRL for ellular0Based Product Testing

AO No. 2013-0012

“Rules and Regulations Governing Accreditation of Health Facilities Engaging in Human Stem Cell and Cell Based of Cellular Therapies in the Philippines”

Philippine Heart Center

NRL for Anatomic Pathology for Cardiac Diseases

Philippine Heart Center

NRL for Cardiac Markers

Research Institute for Tropical Medicine

NRL for Antimicrobial Resistance

qcnet.com

upon receiving the package for NEQAS, the medical technologist must enroll via interne on what website

last Monday

the cut-off date for the submission of results is very ___ of the month

5th days of the succeeding month

results of the NEQAS are viewed on the ____

peer-based estimate of reliability

SDI of NEQAS is

SDI = (mean of the lab - mean of the group) / SDI of the group

formula for SDI

2.00 or greater

SDI result that requires remedial action

1.5-1.99

SDI result where investigation of tests system is recommended

laboratory workflow/ process workflow

is a set of procedural rules used to manage and coordinate tasks between people and systems in the lab

process flow

ensures that all steps and requirements in a defined process are correctly followed to reduce the time and cost of sample handling, preparation and data collection while ensuring the quality of the sample and any associated data is maintained.

standard operating procedures (SOP)

workflows are often guided by ____ and are most effective when thoughtfully developed to reflect real-world practices in the lab

Siemens Dimensions RxL Max

provides maximum productivity with the capacity to grow through automation connectivity

• ability to run up to 91 methods onboard concurrently

• true integration of chemistry and immunoassay for improved workflow efficiency

Siemens Dimensions Rxl Max

a discrete, random access, microprocessor-controlled integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids.

Dade Behring Inc. Flex and Integrated Multi-sensor Technology

what does the siemens dimensions rxl ma uses as reagents and what is IMT

Enzyme-Linked Fluorescent Antibody

is another type of solid phase enzyme immunoassays, involved in the development o fluorescence instead of a color as in ELISA.

Enzyme-Linked Fluorescent Antibody

uses a fluorogenic substrate instead of a chromogenic substrate

ELISA uses p-nitrophenyl phosphate (PNPP), ELFA uses 4-methylumbeliferyl phosphate (4MUP)

difference of ELISA and ELFA

Enzyme-Linked Fluorescent Antibody

more sensitive than ELISA

MINI VIDAS

is a compact version of the VIDAS system with a built-in computer, keyboard and printer

12 samples

how many can the mini vidas run simultaneously

ELFA and immouno concentration technology

what does the mini vidas use as principle

MINI VIDAS

has no carryover risks, requires a one-point recalibration once every 14 or 28 days depending on the assay and optimizes the cost per sample for batch or single sampke testing.

every 14 or 28 days

required re-calibration of MINI VIDAS

MINI VIDAS

uses a single-dose, ready to use reagent strip system

STRIP

this contains al the reagents required for the reaction when using vidas machine

Solid Phase Receptacle

meaning of SRP

Solid Phase Receptacle

is coated with antibodies , antigens and or phage proteins.

Solid Phase Receptacle

acts as a pipetting and reagent transfer device. at each stage of the reaction, it aspirates the reagents in and out.

• this original concept prevents any inter-reagent or inter-sample contamination

11 markers

mini vidas includes how many markers for the diagnosis of recent infection, monitoring of chronic hepatitis, pre or post vaccination immunity controls and screening during pregnancy.

less than 2 hours

duration of hepa profile in mini vidas

40 minutes

duration of the hepa e tesing in mini vidas

Ferritin, PRO-BNP, Procalcitonin, Trop I, D-dimer, CK-MB

tests available for the mini vidas at RMC

prostate cancer

TPSA

• 2 step sandwich

prostate cancer

FPSA

• 2 step sandwich

colorectal cancer, breast adenocarcinoma, lung adenocarcinoma

CEA

• 2 step sanwich

hepatocarcinoma, non-seminomatous germinal testicular tumor, germinal ovarian tumor

AFP

• sandwich using 2 monoclonal Ab

30 minutes

test time of AFP

breast adenocarcinoma

CA 15.3

• 2 step sandwich

• 2-400 u/ml

adenocarcinoma of the pancreas, esophagus, and bile ducts, ovarian mucinous cancer

CA 19.9

• 2 step sandwich

• 3-500 u/ml

ovarian cancer, endometrial adenocarcinoma

CA 125 II

• 2 step sandwich

• 4-600 u/ml

Arkray ADAMS A1c Lite H-8380V

machine for the HBA1c

ion-exchange high performance liquid chromatography

principle of the Arkray ADAMS A1c Lite H-8380V

Siemens Rapidpoint 500e

ABG analyzer that is designed to meet the challenges of point-of-care settings.

60 seconds

duration of testing siemens rapidpoint 500e

enzyme-linked immunosorbent assay

it is a labeled immunoassay that is considered the gold standard of immunoassays

Enzyme-linked immunosorbent assay

this immunological test is very sensitive and is used to detect and quantify substances, including antibodies, antigens, proteins, glycoproteins, and hormones. The detection of these products is accomplished by complexing antibodies and antigens to produce a measurable result

Enzyme-linked immunosorbent assay

this is used to test HIV infection. pregnancy tests and blood typing among others

polystyrene plates

where is elisa performed and

96

polystyrene plates consists of typically how many wells

• they are coated to bind protein very strongly

primary detection antibody

is a specific antibody that only binds to the protein of interest

secondary detection antibody

is a second enzyme-conjugated antibody that binds a primary antibody that is no enzyme-conjugated

ETI MAX 3000 by DiaSorin

is a fully automated microtiter plate analyzer performing the complete sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes plate transports) as well as the photometric measurement and evaluation.

Siemens ADVIA Centaur XP

machine used in serology

Siemens ADVIA Centaur XP

is a high throughput machine that tests 240 test/hour

• has intuitive software for ease of operation

• STAT port guarantees priority sample at any time

• Data archive reduces administrative tasks

30

Siemens ADVIA Centaur XP has an extensive menu with ___ onboard reagents

Atellica 1500 automated urinalysis analyzer

machine that lets you manage more samples with less staff in a shorter tie, while never compromising on high-quality results

• has a digital microscopy imaging with a dual-focusing mechanism to generate clear images

• combined dry-pad urine chemistry and powerful digital microscopy into a single, streamlined unit

up to 240 samples/hour

atellica 1500 automated urinalysis analyzer has a throughput range of

atellica 1500 automated urinalysis analyzer

streamline the detection of UTIs and early kidney disease for better clinical outcomes