CM and PARA - Pregnancy Detection Test and Automation (Day 7) PDF

Preview

Summary

I. Clinical Microscopy and Parasitology Day 7: July 14, 2021Topics:  Pregnancy Test  Automation in Clinical MicroscopyReferences: Video AUBF 6thGen by StrasingerPregnancy Detection Test  HCG Detection test  Urine hCG test are commonly used to determine if someone is pregnant.  Urine pregnancy t...

Description

CLINICAL INTERNSHIP 1 I. Clinical Microscopy and Parasitology

Day 7: July 14, 2021

Topics:  Pregnancy Test  Automation in Clinical Microscopy

References: Video AUBF 6th Gen by Strasinger

  











Pregnancy Detection Test HCG Detection test Urine hCG test are commonly used to determine if someone is pregnant. Urine pregnancy tests qualitatively detect the presence of hCG (human chorionic gonadotropin) in the urine. According to most manufacturers, at-home pregnancy tests are about 99% effective when used as instructed. During the first 8 to 10 weeks of pregnancy, hCG levels normally increase very rapidly. These levels reach their peak at about the 10th week of pregnancy, and then they gradually decline until delivery. Procedures: 1. Take out the pregnancy test from the package 2. Dip the strip into the urine up to the maximum line 3. Hold the strip horizontally and wait about 3 minutes 4. Read the results: Two red lines (Positive); One red line (Negative) Notes: 1. Using your first morning urine when possible. This is the time of day when your hCG levels will be the most concentrated and easily detected. If you do it at another time of day, try and make sure your urine has been in your bladder for at least four hours. 2. Not drinking excessive amounts of fluids before you take a pregnancy test. Many people think this will increase the volume of urine, but it can also dilute (thin out) your hCG levels. 3. Reading the directions that come with the test thoroughly before starting the test, and following every step precisely. Urine and Body Fluids Analysis Automation Urinalysis Automation







Ultimate goal of urinalysis automation is to improve reproducibility and color discrimination while increasing productivity and standardization for reporting urinalysis results. Reflectance Photometry → Spectrophotometric measurement of light reflection that is used in automated reagent strip readers. → Alleviates visual discrimination in urine color → Principle: Light reflection from the test pads decreases in proportion to the intensity of the color produced by the concentration of the test substance. Additional Advantages to Automation → Online computer capability with Laboratory Information System (LIS) interface  Bar coding

   









Manual entry of color, clarity, and microscopic results to be included on the printed report Flagging abnormal results Storing patient and control results Minimal calibration Cleaning and maintenance

Automated Instruments in Urinalysis Semi Automated Instruments → Depends on an operator for specimen mixing, test strip dripping, and microscopic results input Fully Automated Chemistry Analyzer → The tubes of urine are placed on a rack or a carousel and moved automatically through the instrument. Automated Urine Cell Analyzers → Mic, aspirate, dilute, and stain to classify urine sediment particles. Completely Automated Urine Systems → Perform a complete urinalysis that includes the physical, chemical, and microscopic parts of urinalysis

A. Semi-automated Urine Chemistry Analyzers  Test for the chemical components of urine.  Read and interpret the reagent strip results consistently.  Eliminates personnel color bias and timing discrepancies.  Leukocyte, nitrite, protein, blood, glucose, ketone, bilirubin, urobilinogen, pH, specific gravity, color, creatinine, and protein-to-creatinine ratio can be tested depending on the reagent strip used.  Well suited for small and medium volume laboratories  Self calibrating and some instruments perform automatic checks (Auto-checks) to identify strip type and humidity exposure.  The semi-automated instruments requires the operator to: 1. Dip the reagent strip into a well-mixed urine sample 2. Blot the strip to remove excess urine 3. Place the strip onto the reagent strip platform 4. Press the analyte/enter button 5. Results are printed out, and abnormal results are flagged automatically Table A-2

Urinalysis Automation

Equipment Manufacturer Semi-automated Chemistry Instruments Clinitek Advantus Siemens Healthcare Diagnostic, Inc. Clinitek Status Siemens Healthcare Diagnostics, Inc. Urisys 1800 system Roche Diagnostics COBAS u411 Roche Diagnostics DiaScreen 50 U. S. ARKRAY iChem 100 Iris Diagnostics

CLINICAL INTERNSHIP 1 I. Clinical Microscopy and Parasitology

Day 7: July 14, 2021

Topics:  Pregnancy Test  Automation in Clinical Microscopy

References: Video AUBF 6th Gen by Strasinger 

B. Fully Automated Urine Chemistry Analyzers  Designed for a high-volume urinalysis laboratory with user walk-away capability.  Instruments have the ability to load many samples on a carousel or rack at one time with the capability to insert STAT specimen during the run. → The start or analyze button is pressed to begin testing and the specimen automatically moves through the instrument. The specimen is identified. → A sample probe aspirates an exact amount of urine sample and dispenses it directly onto the reagent strip. → The reagent strip advances automatically to the reflectance photometer to measure the color change of each reagent pad. → The strip then advances automatically to the disposal area. → Tests are measured by the dry pad test using reflectance photometry to detect color change, and taking readings at the appropriate time and wavelength for each specific test.  Analytes measured vary by the instrument and may include leukocytes, ketones, protein, glucose, nitrite, blood, urobilinogen, pH, bilirubin, color, clarity, creatinine, and protein-low  Color is measured by either refractance photometry or spectrophotometry  Specific gravity is measured by refractive index  Clarity is a measurement of transmitted or scattered light  The instruments use integrated bar-coded sample identification and allow abnormal ranges to be selected so that samples that require microscopic examination or confirmatory testing can be identified and flagged Table A-2







Routine specimen processing such as centrifugation can affect accuracy because rare elements such as casts or cells may be lost during handling. Results are not quantitative because they must be reported in ranges or averages. Manual microscopy is not cost effective because of the labor and time required to process and analyze the specimen, which ultimately reduces turnaround times for results. Two Automated Urine Cell Analyzers (United States)  Sysmex UF 1000i  iQ 200 from Iris Diagnostics

Sysmex UF-1000i  Uses laser based flow cytometry that measures forward light scatter, side scatter, fluorescence staining characteristics, and adaptive cluster analysis to identify stained urine sediment particles  To perform automated microscopy → 4mL of uncentrifuged urine is aspirated into the instrument which is divided into two channels (each has specific stain)  urine particle analysis  bacteria staining and detection 1. Urine particle analysis → Stained urine sample passes through the flow cell → Particles are identified by measuring the height and width of the fluorescent and light scatter signals (presented in scattergrams and histograms 2. Bacterial Channel → Diluent stabilizes the pH → Stain is specific to the RNA in a bacterial cell → The width of the fluorescent signal measures cellular inclusions → Width of forward light scatter measures the length of cells

Urinalysis Automation

Equipment Manufacturer Fully Automated Chemistry Instruments Clinitek Atlas Siemens Healthcare Diagnostic, Inc. Urisys 2400 system Roche Diagnostics Aution Max AXU . S. ARKRAY 4030 IChem Velocity Iris Diagnostics



C. Automated Microscopy / Automated Urine Cell Analyzers  Provides efficient standardized results in less than 1 minute as compared with approximately 6 minutes using the manual method.  In a routine urinalysis, a test strip determines the chemical analytes, and the formed elements are determined by microscopy.  Manual microscopy is not easily standardized because of the high variation among operators even in the same institution.





 



Resulting values are presented in quantitative cells per microliter and cells per high –or low- powered field Main particles enumerated are RBCs, WBCs, Epithelial cells, hyaline casts and bacteria Results are displayed as scattergrams Flagged particles include pathologic casts, crystals, small round cells, sperm, mucus, and yeast like cells (confirmed manually) Can store up to 10,000 patient results. The UF-1000i can be used independently or integrated with an automated urine chemistry strip reader to create a complete urinalysis system.

iQ 200  -Uses digital imaging and Auto Particle Recognition (APR)  Automatically analyze and preclassify urine particles in uncentrifuged urine based on size, shape, texture and contrast into 12 categories (RBCs, WBCc, WBC clumps, hyaline casts, unclassified casts, squamous epithelial

CLINICAL INTERNSHIP 1 I. Clinical Microscopy and Parasitology

Day 7: July 14, 2021

Topics:  Pregnancy Test  Automation in Clinical Microscopy

References: Video AUBF 6th Gen by Strasinger

  





cells, Nonsquamous epithelial cells, bacteria, yeast, crystals, mucus and sperm. Can also be used for body fluid cell counts Analyzer mixes the sample Aspirates approximately 1mL of urine to a planar flow cell (500 digital photomicroscopic images are taken per sample) Strobe light passes through the collimator to illuminate the specimen -specimen is surrounded by a lamina Digital video camera takes 500 pictures as the specimen passes through the flow cell

Table A-2 Equipment

Urinalysis Automation Manufacturer Automated Microscopy UF-1000i Urine Cell Sysmex Corporation Analyzer iQ 200 Automated Iris Diagnostics Urine Microscopy Iris Diagnostics Urine Analyzer (iQ 200 Sprint) D. Automated Urinalysis Systems / Completely Automated Urine Systems  Combination of automated urine chemistry analyzers and automated urine cell analyzers  The systems can independently perform both physical and chemical testing, microscopy analysis, and a combination of both.  Complete urinalysis report can be sent directly to the LIS or printed out.  The Clinitek Atlas (Siemens Healthcare Diagnostics, Deerfield, IL), an automated urine chemistry analyzer, and the Sysmex UF-1000i (Sysmex Corporation, Mundelein, IL), an automated urine cell analyzer, have been integrated to develop the CLINITEK AUWi System (Siemens), which performs a completely automated urinalysis.

iChem VELOCITY  Where the sample is mixed and aspirated  Physical and chemical analysis iQ 200  Microscopy testing Table A-2 Urinalysis Automation Equipment Manufacturer Automated Urinalysis Systems / Completely Automated Urine Systems iRICELL Urinalysis Systems Iris Diagnostics (iRICELL 3000plus, s, iRICELL 2000plus, iRICELL 3000pro, iRICELL 2000pro, iRICELL 1500) CLINITEK AUWI System



Siemens Healthcare Diagnostics, Inc.

Body Fluid Analysis Automation Hematology analyzers used for body fluids cell counts → ADVIA2120i (Simens) → Sysmex XE 5000 (Sysmex) → Beckman Coulter LH780 → Unicel DxH800 (Beckman Coulter, Inc.)

A. ADVIA21 20i (Simens)  Uses flow cytometry, light scatter and absorbance to count red and white blood cells, and perform WBC differential.  For the Cerebrospinal fluid, CSF specimen is preteated with CSF reagent to fix and spherize the cells → Stable for 4 minutes. To 4 hours at 18 degree celcius to 30 degree Celsius  Automated RBC, WBC, polymorphonuclear and mononuclear and differential results are available within 1 minute of sample aspiration.  Provides rapid automated diagnostic test for fetal lung maturity by counting lamellar bodies in amniotic fluid.

CLINITEK AUWi System (Siemens)  This is an integration of Clinitek Atlas (Siemens) and Sysmex UF-1000i (Sysmex)  Performs a complete automated urinalysis  Requires minimum of 5mL of urine  Results are automatically verified (sent to LIS or printed)

B. Sysmex XE 5000 (Sysmex)  Newest generation hematology analyzer  Includes dedicated body fluid mode  Body fluids can be analyzed without sample preparation or pretreatment.  Sheath flow impedance used to count RBCs  Side scatter and fluorescence intensity to count WBC  Recommended that only non malignant fluid will be analyzed.

ATLAS analyzer  Where the specimen is identified, mixed, aspirated, and tested for physical and chemical components  UF-1000i  Microscopic analysis

Table A-2 Equipment

iRICELL Automated Urinalysis System (Iris Diagnostics)  Consist of the iChem VELOCITY urine chemistry analyzer and iQ 200  Requires minimum of 4mL of urine  Results are transmitted to the LIS of printed

Sysmex XE-5000 using Body Fluids mode

Sysmex Corporation

iQ 200 using Body Fluids Software

Iris Diagnostics

Urinalysis Automation Manufacturer Body Fluid Analyzers ADVIA2120i with Body Fluids Siemens Healthcare Software Diagnostics, Inc.

CLINICAL INTERNSHIP 1 I. Clinical Microscopy and Parasitology

Day 7: July 14, 2021

Topics:  Pregnancy Test  Automation in Clinical Microscopy

References: Video AUBF 6th Gen by Strasinger



Table A-1

Manufactu rer ARKRAY, Inc Iris Diagnostics Roche Diagnostics Siemens Healthcare Diagnostics , Inc.

Measurement Technology Methods in Automated Urinalysis Urine Measurement Technology Color Clarity Specific Gravity Photometry Light Scatter Refractive Index Light Light Refractive transmission/l transmission/l index ight scatter ight scatter Reflectance Turbidity Refractom photometry etry Reflectance Light Refractive photometry transmission/l index ight scatter

ARKRAY AUTION HYBRID AU-4050 Urinalysis Product Overview       















Proven technology for urine chemistry and sediment analysis (in one small package) Enhance workflow efficiency Accurate results time after time Process up to 200 chemistry samples in an hour Delivers rapid results in 2 minutes and 15 seconds An Ideal fit for any size laboratory Compact fully automated and integrated urine analyzer that consolidates to industry proven technologies to perform both urine chemistry and sediment analysis in one small package. This total walk away system minimizes labor intensive manual steps and frees operator time for other valuable activities. The easy-to-use analyzer features one-step loading of trusted ocean dry pad urine chemistry test strips with no calibration required. During analysis the chemistry module aspirates the sample and precisely dispenses urine on each pad for measurement. The module measures nine chemistry’s: → Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrites, and Leukocytes For improved accuracy the color compensation pad accounts for normal urine colors and abnormal color detection notifies users of false positive reactions. It also performs specific gravity and color, turbidity measurements. The sample rack then advances based on user defined criteria to the flow cytometry module, here a probe mixes the sample and aspirates into two separate chambers. → Sediment chamber is heated to 35°C to remove any amorphous urates.  The urine sample is mixed with diluent and fluorescent stain to accurately detect and enumerate formed elements in the sample.

→









It can accurately detect and enumerate red blood cells (RBCs), white blood cells (WBCs), epithelial cells, and casts  The analyzer also flags six additional elements for review Bacteria Chamber mixes the urine sample with diluent and nucleic acid stain and is heated to 42°C to suppress nonspecific staining.  This coupled with the anti carryover rinse offers uncompromised bacteria discrimination

The combination of urine chemistry and sediment analysis technologies generates standardized and accurate results in one consolidated report providing operator confidence time after time. Instrument parameters can be used to create effective reflux culture criteria to minimize time and costs associated with reviewing contaminated or negative urine cultures. The high capacity system can meet the busiest laboratories workload demands by processing up to 200 chemistry samples an hour and delivering rapid results in as little as 2 minutes and 15 seconds. The hybrid analyzers compact size makes it an ideal fit to meet space constraints of laboratories of all sizes and volumes

Disclaimer: ARKRAY recommends utilizing proper protective equipment and attire critical for laboratory safety when running samples....