Lab Management-Lesson 12-Current Trends in the Laboratory PDF

MT TERM LAB MAN LECTURE \ CASTAÑARES 03 LESSON 12 – CURRENT TRENDS IN THE LABORATORY TOPIC OUTLINE...

MT TERM LAB MAN LECTURE \ CASTAÑARES 03 LESSON 12 – CURRENT TRENDS IN THE LABORATORY TOPIC OUTLINE MICROCHIP I. Automation Researchers have developed a tiny microchip that is a. Pre-analytical stage embedded in the plastic of the test tube and used to store b. Analytical stage all relevant information such as when and where a c. Post-analytic stage sample is from, as well as the patient’s name. II. Information technology When the test tube is placed into an analyzer, the III. Laboratory measurement or Testing technology equipment can record details on the embedded chip of exactly what went on in the analysis. This would mean that the test tube itself carries the samples’ entire history with LABORATORY TECHNNOLOGY no need for technicians to write up a laborious report. Laboratory technology is often at the forefront of medical advances innovation in laboratory technology SPECIMEN PREPARATION which includes both new tests and advances in equipment The clotting of blood in specimen collection tubes and their and testing techniques has made testing more efficient subsequent centrifugation as well as the transfer of serum and automated. to secondary tubes require a long time to complete. THREE MAJOR TECHNOLOGICAL INNOVATIONS: The use of whole blood in the assay system shortens the o Automation specimen preparation time. ▪ Pre-analytic stage Automated or semi-automated ion-selective electrodes ▪ Analytic stage have been incorporated into automated systems to ▪ Post-analytic stage provide test results within minutes. This is now commonly o Information technology used for assays of electrolytes and other analytes. o Laboratory measurement or Testing technology AUTOMATION ANALYTIC STAGE Laboratory automated processes (just like the manual In most laboratory settings, the analytic stage of testing is processes) occurs in three stages: more automated and automated technology allows groups of tests called panels or profiles to be run on the PRE-ANALYTIC STAGE same sample. PNEUMATIC TUBE SYSTEM (PTS) Examples: Lipid panel (includes cholesterol and Provides rapid specimen transport and are reliable triglycerides) and dialysis panel (includes BUN and when installed as point-to-point services. creatinine) Pneumatic tubes also known as capsule pipelines or pneumatic tube transport are systems that propel A. CLINICAL CHEMISTRY cylindrical containers through networks of tubes by Automated systems in clinical chemistry can be compressed air or by partial vacuum. differentiated based on two characteristics: volume of They are used for transporting solid objects such as testing performed on the instrument and their ability to blood bags and blood samples in evacuated collection connect to instrument clusters or a larger laboratory tubes. automation system Although it expedites specimen transport, close attention Functionalities of automated systems in clinical chemistry to the design is necessary to prevent hemolysis of the include: specimen. Diverse An analyzer with more than 85 assays that o Avoidance of sudden accelerations and assay Menu cover general chemistries, esoteric or decelerations as well as the use of proper packing specialized tests, special proteins, materials inside the carriers can help to minimize therapeutic drugs and drugs of abuse hemolysis. Multiple An analyzer with a dual function open Methods of system that can perform chemistries and BARCODING Analytical enzyme-linked immunosorbent assays CLSI is developing a new standard for the use of two- Detection (ELISA) and they are also currently dimensional bar codes in clinical and anatomic working towards integrating pathology laboratories. Chemiluminescence immunoassays o Before, we had the traditional one-dimensional bar (CLIA) and ion-selective electrode code. capabilities as well Now, the two-dimensional bar codes available include Onboard QC An analyzer with an internal quality the following: Management assurance system that performs more than o Maxi Code, 40 automatic checks during sample and o Quick Response (QR) Code (since these codes can calibration cycles to verify correct be read quickly by cellphone), performance of sensors, reagents, fluidics o Data Matrix, and electronics. The IQA system reports a o Aztec Code test parameter only when all the 40 Two-dimensional bar codes offer the prospect of encoding performance checks are successful. Other more data in smaller formats and having greater QC systems also include stored control reliability than one-dimensional bar codes. data with options to view and print the With the use of two-dimensional bar codes, there is Levey-Jennings or the QC range plots. unequivocal positive identification of each specimen is LIS Some machines have a file import/export achieved in analyzers with bar code readers. connectivity method that makes data transfer versatile and adaptable to many LIS systems. MADE BY: CLEMENTE | 2D-MT 1  TRANS: CURRENT TRENDS IN THE LABORATORY Based on the reagents, IgG, IgM, and Automated instruments for clinical chemistry in large- IgA can be detected separately or volume laboratories have: combined as total antibody. Improved they can handle more tests per hour The drive-thru testing being conducted in efficiency with a larger capacity for specimens Manila and other areas of NCR like and reagents Pasig are using Enhanced More physical a distinct disadvantage; floor space, Chemiluminescence Immunoassays plant requirements ventilation, water supply, electrical (ECLIA) and the antibody testing and drainage requirements available in the CDUH laboratory is also More complex maintenance procedures using CLIA. B. IMMUNOCHEMISTRY AND IMMUNOLOGY 2. NEUTRALIZING ANTIBODY DETECTION There are many antibody-based detection methods which FDA has not yet authorized the use of neutralization tests includes nephelometry, turbidimetry and a wide range of for SARS-CoV-2. immunoassays which includes ELISAs, FIAs The test determines the functional ability of antibodies (Fluorescence Immunoassays) and CLIAs. to prevent infection of virus in vitro. Involves incubating serum or plasma with live virus Current Methods of Testing for Covid-19- divided into followed by infection and incubation of cells. three: Since this uses live virus, testing will require either BSL-3 or BSL-2 laboratories, depending on what form of the COVID-19 ANTIBODY TESTING SARSCoV-2 virus is used. Serologic tests detect waning or past SARS-CoV-2 virus TYPES OF NEUTRALIZATION TESTS: infection indirectly by measuring the host’s humoral Virus Includes plaque-reduction immune response to the virus. neutralization neutralization test and This is through detection of antibodies produced by the tests (VNT) microneutralization. host over days to weeks after infection with the virus. Use a SARS-CoV-2 virus from a The strength of antibody response depends on: clinical isolate or recombinant o Age, SARS-CoV-2 expressing reporter o Nutritional status, proteins. o Severity of disease, and Requires BSL-3 laboratories and may o certain medications or infections (like HIV) that take up to 5 days to complete suppress the immune system. Pseudovirus Use recombinant pseudoviruses (like In some people with COVID-19, weak, late or absent neutralization vesicular stomatitis virus, VSV) that antibody responses have been reported. tests (pVNT) incorporate the S protein of SARS- According to WHO, studies show that majority of patients CoV-2 develop antibody response only in the second week after Can be performed in BSL-2 onset of symptoms. laboratories depending on the VSV SARS-CoV-2 infections are somewhat unusual because strain used IgM and IgG antibodies arise nearly simultaneously in detecting rapid diagnostic tests for patient care but serum within 2- 3 weeks after illness onset. Usually it is encourages the continuation of work to establish their the IgM that rises first before IgG but in SARS-CoV-2 usefulness in disease surveillance and epidemiologic infections, the two antibody classes arise nearly research. simultaneously. USES OF COVID-19 ANTIBODY TESTING: o Therefore, the detection of IgM without IgG is o Support the development of vaccines uncommon and how long IgM and IgG antibodies o Determine the proportion of a population previously remain detectable following infection is not yet known infected with SARS-CoV-2 and therefore may have since there have been reported cases of reinfection. higher rates of herd immunity ANTIGENIC TARGETS used in Antibody testing: o Assist in determining who may qualify to donate o Spike glycoprotein (S) convalescent plasma. o Nucleocapsid phosphoprotein (N) LIMITATIONS OF COVID-19 ANTIBODY TESTING: o The presence of antibodies cannot be equated with TYPES OF ANTIBODY TESTING an individual’s immunity from SARS-CoV-2 infection. o Some tests may exhibit cross-reactivity with other 1. BINDING ANTIBODY DETECTION coronaviruses and produce false-positives. o Some persons may not develop detectable These tests use purified proteins of SARS-CoV-2, not live antibodies after coronavirus infection. virus, and can be performed in lower biosafety level laboratories. Based on current data, WHO does not recommend the use of antibody Depending on the complexity of assays, these tests can be performed rapidly in a field setting or in a few hours in MOLECULAR DIAGNOSTIC TESTING FOR SARS-COV-2 a laboratory. 2 categories of Binding antibody detection tests: Point-of- Are lateral flow devices that detect IgG RT-PCR DIAGNOSTIC PANEL care tests or IgG and IgM, or total antibody in The COVID-19 RT-PCR Test is a real-time reverse (POCT) serum, plasma, or whole blood. transcription polymerase chain reaction (rRT - PCR) An advantage of some point-of-care test and is the gold standard for COVID-19 diagnosis. tests using whole blood is that they can Polymerase Chain Reaction testing can detect even very be performed on blood samples in a sample by duplicating it many times over through a obtained by fingerstick rather than complex laboratory process called amplification. venipuncture. A test sample if is first swabbed and processed to isolate Laboratory Use ELISA or CLIA methods for genetic material. tests antibody detection using blood samples. For the test sample, studies have shown that nasopharyngeal swabs showed higher positive rate than oropharyngeal swabs and that is why currently existing MADE BY: CLEMENTE | 2D-MT 2  TRANS: CURRENT TRENDS IN THE LABORATORY protocols require both types of swabs to be collected to The resulting solution is added to a test strip. If the solution increase sensitivity of the test. contains viral proteins, they travel along the strip and It is used to amplify RNA targets since the SARS-CoV-2 eventually get trapped by a monoclonal antibody which virus is an RNA virus. recognizes a specific segment of the SARS-CoV The RNA template is converted into complementary DNA nucleocapsid protein. by the enzyme reverse transcriptase. The test results can be read by a device that measures The test uses: either the florescence signals (FIA) or lateral flow 3 primer and detect three regions in the SARSCoV-2 immunochromatography type of test. probe sets nucleocapsid (N) gene Advantages: 1 primer and detect human RNase P (RP) in a clinical o The speed of the test, which can provide results in probe set sample minutes The human RNase P is for the o Can generally be produced at a lower cost than PCR detection of human nucleic acids tests and is used as a control for sample ▪ However, antigen tests maybe fast and cheap integrity. but they are not as sensitive as the molecular diagnostic test. This is because antigens Steps: detected are expressed only when the virus is Denaturation separation of two strands in the DNA actively replicating. Therefore, such tests are double helix by raising the only best used to identify acute or early temperature of the mixture infection and how well these antigen tests work also depends on several factors. Annealing the temperature is lowered and the Factors that affect Antigen testing: primers (small pieces of specifically engineered genetic material) are o Time from onset of illness o Concentration of the virus in specimen introduced and bind to the isolated viral genetic material initiating o Quality of the specimen and how it is processed amplification. o Precise formulation of the reagents in the test kits For antigen tests, there may be false positive results Primers mark the target sequence that because they could occur if the antibodies on the test strip will be amplified. also recognize antigens of viruses other than COVID-19 Elongation New strands of DNA are made using such as from human coronaviruses that cause the human or Extension the original strands as templates. cold. A DNA polymerase enzyme (usually With the limited data now available, WHO does not Taq polymerase) joins free DNA currently recommend the use of antigen detecting rapid nucleotides together. diagnostic tests for patient care although research into Taq polymerase is an enzyme their performance and potential diagnostic utility is highly originally isolated from a thermophilic encouraged. bacteria called Thermus aquaticus. The RT-PCR remains to be the gold standard for the diagnosis while the antigen and antibody testing are used The cycle is repeated many times (usually 20-30 times as for epidemiological surveillance. most processes using PCR need large quantities of DNA) and it takes 2-3 hours to get a billion or so copies. C. URINALYSIS The fluorescence intensity is monitored at each PCR cycle since fluorescent markers bound to the copies during PCR Semi-automated urine analyzers can provide automated are released and can be detected when amplification reading of urinalysis test strips in medium to high occurs. throughput settings Positive result - when there is viral genetic material in the Fully automated urinalysis analyzers perform chemical sample so amplification occurs releasing enough analyses, analysis of sediment or cellular elements using fluorescent markers to be detected flow cytometry Negative result - when there is no viral genetic material Some combine both chemical and particle analysis in the sample so amplification will not occur and no modules into a work cell so that particle analysis can be fluorescent markers will be detected. conducted automatically on specimens with abnormal test strip results. CDC INFLUENZA SARS-COV-2 MULTIPLEX ASSAY Instruments for microscopic urine analysis have also been applied to automating body fluid cell counting CDC’s newest laboratory test, currently in production, will detect two types of influenza viruses (A and B) and D. HEMATOLOGY SARS-CoV2 at the same time. With a single test that diagnoses current infection with one Analyzers that perform a complete blood count has been or more of these viruses, this will allow public health automated through the use of: laboratories to continue influenza surveillance while also Coulter Based on changes in electrical testing for SARS-CoV-2. principle impedance produced by non- Information about both viruses will help public health conductive particles suspended in an officials to control the spread of influenza as well as electrolyte solution as they pass COVID-19 in the community. through a small aperture between The US FDA issued an emergency use authorization for electrodes. the use of the CDC Influenza SARS-CoV-2 Multiplex RBCs, white blood cells and platelets Assay on July 2, 2020. are identified by their sizes. Flow Typically count cells often stained with ANTIGEN TESTING cytometry supravital or fluorescent dyes that travel in suspension one by one past a Based on detection of Viral Proteins expressed by the laser light source. SARS-CoV-2 virus in respiratory tract specimens such as Information is derived through nasopharyngeal and nasal swabs. measurement of light scatter when a Patient sample is added to a solution that breaks up the cell is struck by the laser beam (both virus, freeing its proteins for recognition by the test. MADE BY: CLEMENTE | 2D-MT 3  TRANS: CURRENT TRENDS IN THE LABORATORY side-scattered and forward-scattered Serve to reduce repetitive manual lab tasks, allowing for light). greater hands-free data processing and results Light scatter is then used to estimate management. cell shape, cell size, cellular granularity, nuclear lobularity and cell ELECTRONIC HEALTH RECORD (EHR) surface structure. A digital record of health information Digital Automated systems to classify and Streamlined sharing of updated, real-time information microscopic count cell types based on a digital Allows a patient’s medical information to move with them analysis scan of the slide or a representative Access to tools that providers can use for decision making number of regions of interest. These are designed to automate the time-consuming ELECTRONIC MEDICAL RECORD (EMR) manual effort associated with traditional microscopy. A digital version of a chart The system utilizes proven digital image analysis Not designed to be shared outside the individual practice technology to locate and examine cells in blood and other Patient record does not easily travel outside the practice body fluids. Mainly used by providers for diagnosis and treatment This will save time, accelerate turn-around-time, increasing the technologist’s productivity through high AUTOMATED CRITICAL VALUE NOTIFICATION SYSTEM volume labs. (ACVNS) When it identifies clinically significant changes in cardiac E. MICROBIOLOGY troponin (used in the diagnosis of myocardial infarction) Pre-analytical, analytical and post analytical steps that are results, when the software identifies the first increase of automated include: cardiac troponin, it sends an alert message to the o Specimen decapping and recapping laboratory information system. o Petri dish barcode labeling The performing lab professional then calls the patient’s o Plate inoculation and streaking nurse, who informs the attending physician o Gram stain preparation The software also sends the results to the physician o Automated incubation through the EMR o High-resolution digital imaging of plates o Colony sampling for biochemical identification AUTOMATED TESTING ALGORITHMS (ATA) o Antibiotic susceptibility testing o Analysis using Matrix-Assisted Laser Desorption ALGORITHM Ionization Time-Of-Flight (MALDI-TOF) Mass is a process/set of rules to be followed by a computer Spectrometry Includes evidence-based order sets for the health ▪ A microorganism colony cultured from a patient system’s Computerized Physician Order Entry (CPOE) sample is placed onto a MALDI “target” plate, software treated with formic acid, embedded within Algorithm for Clostridium difficile testing based on the matrix, and the laser is aimed at the target plate Infectious Diseases Society of America guidelines to begin sample collection. o In most cases, C. difficile is contracted in the ▪ The detected molecules are not identified from healthcare setting and is connected to antibiotic the resultant spectrum but rather from the treatment and it is the common cause of health care unique pattern produced by proteins and other associated diarrhea. biomolecules from the microorganism is then o C. difficile GDH assay is qualitative enzyme-linked matched to a spectrum of a known fluorescent assay technique that detects the C. microorganism from a database (much like difficile antigen, glutamate dehydrogenase (GDH), fingerprints are matched to identify individuals). as a screen for the presence of C. difficile in stool Each spectrum contains peaks unique to specimens from persons suspected of having C. specific genera, specie and strains and the difficile infection. MALDI-TOF machine uses an o If positive, it proceeds to the C. difficile toxin A & B algorithm/computerized process to produce a (CDAB) test. value on the level of confidence in its o This algorithm will rapidly provide the information identification. needed to help you identify and contain the spread of infection and this will help decrease patient POST ANALYTIC STAGE morbidity and mortality rates. Today, the use of the Internet to report results has greatly reduced costs. LABORATORY MEASUREMENT AND TESTING Billing and collection processes may become more TECHNOLOGY automated in the future. Laboratories may automatically obtain and transmit all GENETIC TESTING required documentation through electronic systems. Genetic testing is a type of medical test that identifies changes in chromosomes, genes, or proteins. CLOUD LIMS There are several types of genetic testing: laboratory information management software built exclusively on cloud-based technology or web based. DIAGNOSTIC TESTING It is used to identify or confirm the diagnosis of a disease INFORMATION TECHNOLOGY or condition in a person or a family. Like many other areas of health care delivery, laboratory It gives a yes or no answer in most cases services are experiencing an IT revolution. PREDICTIVE GENETIC TESTING LIS/LIMS This determines the chances that a healthy individual with Ensures not only the privacy and security of patient data, or without a family history of a certain disease might but also the quick retrieval of patient data when diagnosis develop that disease. and early treatment are tantamount to life-saving efforts. MADE BY: CLEMENTE | 2D-MT 4  TRANS: CURRENT TRENDS IN THE LABORATORY This is for those diseases which manifests themselves in Gold nanoparticle bio-barcode assay probe for the adulthood such as some types of cancer, cardiovascular detection of prostate specific antigen after radical diseases and some single-gene disorders prostatectomy for prostate cancer. This is especially useful since the available PSA immunoassays lack sensitivity. PRE-SYMPTOMATIC GENETIC TESTING Promises to affect the clinical laboratory industry through This is used to determine whether persons who have a the development of miniaturized components and devices family history of a disease but no current symptoms, for chemical processing and measuring sensors. have the gene alterations associated with the disease. This technology could prove to be extremely useful in the movement toward developing small, versatile point-of- CARRIER TESTING care tests. This is performed to determine whether a person carries Nanotechnology is already used in tests for tuberculosis one copy of an altered gene for a particular disease. and colon cancer The disease maybe autosomal recessive- a disease is Another potential application is in drug administration present in an individual only if two copies of the outer gene TECHNOLOGY’S EFFECT ON SITE OF SERVICE 1 are inherited and couples who both carry the same autosomal recessive gene have a 1 in 4 or 25% chance POINT-OF-CARE TESTING with each pregnancy to have a child with that disease. New technologies have made POCT devices small and portable with improved specimen collection techniques. PRENATAL DIAGNOSIS The most common is the glucometers which are used for This is used to diagnose a genetic disease or condition in capillary blood sugar levels. a developing fetus and includes maternal serum However, in some cases for POCTs, there may be a trade- screening, ultrasound or sonograms, amniocentesis, off between the convenience of the POCT and the quality chorionic villus sampling, and percutaneous umbilical of the laboratory test result. blood sampling. HOME TESTING PREIMPLANTATION STUDIES Home testing is decentralized and physicians may not These are used following In-vitro Fertilization (IVF) to receive the test results unless they are provided manually diagnose a genetic disease or condition in an embryo by patients or entered into shared Internet-based data- before it is implanted into a mother’s uterus monitoring systems. The most common examples are pregnancy testing kits. NEWBORN SCREENING These home testing products are relatively inexpensive, This is performed in newborns in state public health over-the-counter diagnostic and monitoring kits and devices programs to detect certain genetic diseases for which early diagnosis and treatment are available EFFECT ON CLINICAL LABORATORY STAFF PHARMACOGENOMICS REQUIREMENTS Pharmacogenomics analyzes how the genetic makeup The growth in automation and robotics is decreasing the of an individual affects his/her response to drugs. need for nontechnical staff in the laboratory and reducing A lot of deaths occur every year because medicines are the need for labor would have profound effects on the cost made and sold on a standardized basis even though of performing testing since labor constitutes approximately people vary substantially in the way they respond to these 60% of the total cost of laboratory services. compounds. Labor cost savings may be offset somewhat by a need Some people may respond to normal doses, others to for additional IT staff to monitor and maintain the lower or higher doses while some respond to alternative automated systems medication. Pharmacogenomics aims to develop rational means to SUMMARY: optimize drug therapy, with respect to the patients' Clinical laboratories are in the midst of a technological genotype, to ensure maximum efficiency with minimal revolution that is likely to continue during the twenty-first adverse effects. century. New technology is positively associated with Pharmacogenomics could result in better health increased efficiency, reduction in errors and improved outcomes and long-term cost-saving substantial quality in the delivery of health care services. enough to offset the initial expense, particularly if Automation and shifts in the sites where laboratory screening efforts target subpopulations that are more likely services are delivered will result in major shifts in to be susceptible to the genetic characteristic. laboratory staffing needs (trends appear to indicate that much routine testing in the future could be delivered NANOTECHNOLOGY through POCT and home-based testing) The science of building miniature devices out of very Demand for skilled IT professionals, experts to monitor small particles such as individual atoms, molecules, and service robotic equipment, and allied health viruses, or cells professionals is likely to grow. A lab-on-a-chip (LOC) is the miniaturization of analytical Overall decreases in labor costs, however, will likely lead devices that integrate several laboratory operations such to decreases in the cost per test. as PCR and DNA sequencing into a single chip on a very small scale (only a few mm to a few cm2 ). It can handle extremely small fluid volumes down to picolitres. It has REFERENCES been successfully used in the detection of analytes such Notes from the discussion and PPT by Lorreine Denise as electrolytes. Example is the iSTAT which is a rapid W. Castañares, MSMT analyzer that rapidly analyzes very low volumes of blood and it contains arrays of electrodes deposited on silicon cartridges to form a biosensor. When a few drops of blood enter the cartridge via capillary action, they are chemically treated before an analysis and after which a handheld electromechanical device measures the concentration of electrolytes and other analytes in the blood sample. 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