POCT

Why choose REALY?

Professional Team

REALY has a development department dedicated to the development of IVD reagents. Our technical staff is responsible for process development, process improvement, and formulation development.

Quality Assurance

We have CE certificates, ISO 13485 quality system certification, Manufacture License, and Marketing Authorization in the country of origin. We are also preparing the FDA and other certificates.

Strict Quality Control

Maintain strict quality control during the process. Our product safety is checked through extensive testing, sampling and verification procedures to meet final product specifications.

Sales to The World

We participate in medical exhibitions in many countries such as Medlab, Medica, and AACC every year. The sales network has covered more than 80 countries and regions, distributing high-quality products at very competitive prices.

What is POCT ?

Point-of-care testing (POCT), also called near-patient testing or bedside testing, is defined as medical diagnostic testing at or near the point of care—that is, at the time and place of patient care.

POCT is often accomplished through the use of transportable, portable, and handheld instruments (e.g., blood glucose meter, nerve conduction study device) and test kits (e.g., CRP, HBA1C, Homocystein, HIV salivary assay, etc.). Small bench analyzers or fixed equipment can also be used when a handheld device is not available—the goal is to collect the specimen and obtain the results in a very short period of time at or near the location of the patient so that the treatment plan can be adjusted as necessary before the patient leaves.

Automatic Chemiluminescence Immunoassay System MiNi-CLIA RL-C2000

Features of POCT

POCT should be simple to use.
Reagents and consumables should have durable resistance during storage and use.
POCT results should align with established laboratory methods.
POCT should ensure safety during testing.

Important Benefits of Point-of-Care Testing

POCT is Faster Than Laboratory Testing
The capability to conduct tests and receive instant results near the patient is the main advantage of point-of-care testing. The test results only take a few minutes to obtain, making it significantly faster than laboratory testing.

POCT Can be Done Anywhere and Anytime
One of the main highlights of point-of-care testing is that it can be done anywhere. Because of its portability, point-of-care testing can detect infectious diseases in remote or resource-limited areas that do not have access to large laboratories in the city.

POCT Can be Performed by Any Healthcare Practitioner
The latest point-of-care devices are now more compact and easier to use; even staff who are not expertly trained in clinical laboratory services can use them.

POCT is Beneficial in Emergency Situations
Point-of-care can help alleviate the overcrowding in the emergency room by reducing the time it takes to treat patients. It can also be used to focus on the prevention, early detection, and monitoring chronic conditions.

POCT is Cheaper Than Laboratory Testing
Point-of-care testing devices are generally smaller and could be brought anywhere. They are also inexpensive compared to the usual diagnostic equipment used by laboratories.

Types of Point of Care Testing

Types of POCT: Inflammation

Instant testing for whole-process C-reactive protein (hsCRP+conventional CRP)
Instant testing for procalcitonin (PCT).

Types of POCT: Cardiac

Instant testing for N-terminal pro-brain natriuretic peptide (NT-proBNP)
Instant testing for cardiac troponin I (cTnl), myoglobin (MYO), and creatine kinase isoenzyme (CK-MB).

Type of instant detection: Tumor

Alpha-fetoprotein (AFP) instant detection
Prostate-specific antigen (PSA) instant detection.

Types of POCT Devices

Small Handheld POCT Devices

There are a variety of small POCT devices on the market, ranging from simple blood glucose meters to, for blood gas analysis, sophisticated small cassette devices. These devices are truly portable and are often used by the patient themselves or by a healthcare professional near the patient, such as at the bedside, in a clinic, or in the patient's home.

Larger Benchtop POCT Devices

These devices are similar in design to some of the instruments used in central laboratories. They are usually variations of devices used in traditional laboratories. They have high throughput and high accuracy. These point of care testing devices can be moved to outpatient clinics, hospitals and community health departments to provide services such as diagnostic testing and care.

Available POCT Devices

Blood gases and electrolytes analyzers

Coagulation

Blood Chemistries, ex. Glucose, cholesterol, uric acid

Drug abuse

Pregnancy screening

Cardiac markers

Hemoglobin and Hematocrit

When to Use Point of Care (POC) Tests?

Although the option of point-of-care testing is widely available for many health parameters ranging from pregnancy to drug abuse, point-of-care (POC) testing has proved to be particularly useful for the followings:

The consistent screening of people with chronic diseases.

Rapid screening of highly infectious diseases.

Emergency situations where immediate decision making is decisive.

Remote, resource-limited, or disaster-ridden settings.

Application of POCT

POCT for Hematology

Prothrombin time analyzers, for evaluating blood clots.
APTT testing, for hemostatic assessment.
D-dimer testing, to rule out pulmonary embolism or DVT.
Viscoelastic assays, for trauma and obstetrics.
Activated clotting time testing, for monitoring heparin levels.
Malarial antigen testing, for screening for malaria.

POCT for Clinical Trials and Research

Identifying participants with anemia.
Identifying participants with blood disorders.
Screening for infections.
Monitoring patients’ reactions to clinical trial drugs (companion diagnostics).

Where Can POCT be Used?

01/

Home use, self-testing

02/

Pharmacy

03/

Paramedical support, ambulance

04/

Nursing home or aged care centre

05/

General medical practice, primary care (US terminology: POL, Physicians office laboratory)

06/

Rural (remote) hospital or health clinic

07/

Critical care facility in major hospital (ED, ICU, CCU, etc)

08/

Hospital ward or hospital clinic

09/

Sports clinic

10/

Workplace drug screening.

Kit Contents of POCT

Each Kit Contains:
Antibody test card in a sealed pouch with desiccant
Sample diluent
User manual: 1 piece/box.

A Test Card Contains:
A plastic shell and a reagent strip which is composed of a sample pad, a colloidal gold pad, nitrocellulose membrane with two test lines (these two lines are coated with anti-human IgM and IgG antibody respectively), the control line, absorbent paper and liner.

Sample Diluent Composition:
Phosphate buffered saline, proteins, detergent, preservative, stabilizer.

General POCT Testing Procedures

A Sample is Obtained for Analysis

This could be a drop of blood for blood glucose concentration via a glucometer or urine for beta-hCG. Various requirements regarding the patient's state, the specimen's state, and the preparation needed for accurate testing exist.

The Sample is Applied to the POCT Device

Immediately before this step, a reagent may facilitate accurate testing. This allows for the distribution of the antigen throughout the solution and increases test accuracy. In some types of POCT, the sample can be directly applied to the device, which typically includes a disposable cartridge for analyzing the analyte. This disposable cartridge can be disposed of after use, reducing the risk of cross-contamination.

Read Test Result

Once the test is performed, the result is obtained and can be directly transferred to the patient's electronic medical records (EMR) if the POCT device is integrated or interfaced with the EMR system.

Storage and Use of POC Testing Kits

Test kits can be stored at room temperature, as long as the temperature never exceeds 30° C. The temperature must be tracked daily and range between 2-30° C.
The temperature gauge used at the site should record the high and low temperature each day as well as the current temperature. This temperature must be tracked daily. A template for an environmental monitoring log is provided for this purpose.
If a temperature outside 2-30°C is recorded, quality control testing of all stored kit lots must be done, before further client testing can continue.

Our certificate

We have passed various certificates such as CE and ISO, and the products we provide have quality assurance.

Common Problems of POCT

Q: What is a POCT lab test?

A: Point-of-Care Testing (POCT) is clinical laboratory testing conducted close to the site of patient care where care or treatment is provided.[1] POCT provides rapid turnaround of test results with the potential to generate a result quickly so that appropriate treatment can be implemented, leading to improved clinical or economic outcomes compared to laboratory testing.

Q: What is the most common POCT test?

A: The most common POCT tests include blood glucose monitoring, home pregnancy tests, rapid strep, hemoglobin, as well as prothrombin time/international normalized ratio tests. For example, the rapid strep test allows for patients to be treated earlier and reduces the risk of complications from not treating it.

Q: What are the POCT devices?

A: Point of care (POC) diagnostic devices are used to obtain diagnostic results while with the patient or close to the patient. Used in doctors' offices, hospitals, and in patients' homes, POCT diagnostic devices give quick feedback on many sorts of medical tests.

Q: What is the purpose of point of care testing?

A: What is Point-of-care Testing? Point-of-care tests produce rapid, reliable results that aid in identification and monitoring of acute infections or chronic disease. POCT involves screenings and tests at or near the point of care, which produce actionable results within minutes.

Q: What is the difference between lab and POCT?

A: Point-of-care testing, also known as near-patient testing, typically means carrying out a test using a device or test kit in the presence of the patient and without the need to send a sample to a laboratory. Many new point-of-care devices utilize technological advancement to improve the quality of care.

Q: How accurate are POCT tests?

A: Found that sensitivity and specificity were 99.1% (95% CI 94.8-100.0) and 71.0% (95% CI 64.4-76.9), respectively, for invasive POCT Hgb and 81.6% (95% CI 72.5-88.7) and 75.4% (95% CI 68.8-81.1), respectively, for non-invasive POCT Hgb.

Q: What is POCT also known as?

A: Point-of-care testing (POCT), also known as near-patient testing, refers to any analytical test performed outside the laboratory and may be located either within a hospital as an adjunct to the main laboratory or for primary healthcare outside the hospital setting. The users of this service are often nonlaboratory staff.

Q: Is POCT more expensive?

A: Point-of-care testing (POCT) is usually more expensive on a unit-cost basis than testing performed in a central laboratory. It is difficult to manage POCT and to maintain regulatory compliance, especially in large institutions. However, some POCT technologies have improved patient outcomes (patient self-glucose monitoring in the home, tight glycemic control in intensive care settings) or hospital or emergency department operations.

Q: What are the disadvantages of POCT testing?

A: The disadvantages of POCT such as incorrect handling and/or maintenance of the analyzers by nontrained clinical staff, inadequate or even absent calibrations and/or quality controls, lack of cost-effectiveness because of an increased number of analyzers and more expensive reagents, insufficient documentation and difficult comparability of the obtained POCT-results with routine laboratory results, are strongly evident.

Q: Who can perform POCT?

A: POCT is usually performed by non-laboratory trained individuals such as licensed practical nurses, registered nurses, nurse aides, physicians, residents, students, technical assistants, respiratory therapists, emergency technicians, and pharmacists among others.

Q: Is ECG a POCT?

A: Point-of-care tests (POCTs) are rapid diagnostics that can be performed at the point of care in a clinic or home setting instead of in a conventional central laboratory (examples of these tests include blood glucose, blood pressure, electrocardiogram, and carbon monoxide breath tests).

Q: What is POCT in pharmacy?

A: Point-of-care testing (POCT) using rapid diagnostic tests for infectious disease can potentially guide appropriate use of antimicrobials, reduce antimicrobial resistance, and economise use of healthcare resources. POCT implementation in private retail settings such as pharmacies and drug shops could lessen the burden on public healthcare.

Q: What are three advantages of POCT?

A: Point-of-care testing (POCT) enables more rapid clinical decision making in the process of diagnosis, (rule-in or rule-out), treatment choice and monitoring, and prognosis, as well as operational decision making and resource utilization.

Q: Is POCT qualitative or quantitative?

A: 5mL volume of human urine is distributed bimonthly, with a minimum of 6 samples distributed over the year covering a clinically relevant range for screening. Both manual and automated POCT device results can be submitted as qualitative (neg, pos, or +,++,+++) or semiquantitative results (e.g. range band 2-5mmol/l).

Q: What is a major advantage of rapid POCT testing?

A: The biggest advantage to POCT is that by providing faster access to test results, this can, in turn, expedite the speed of diagnosis and subsequent treatment. In addition, POCT in the right situations (such as an urgent care location, pharmacy, or emergency department) can reduce unnecessary hospital admissions or expensive imaging tests.

Q: What are the methods of POCT test?

A: POCT methods include manual methods, such as urine dipsticks and test kits, hand-held devices, and bench top instruments. Rapid test kits and dipsticks usually provide qualitative or semi-quantitative results.

Q: What are the characteristics of POCT?

A: Fast and reliable response. The testing time should not be longer than 1 hour.
Accuracy. The sensitivity and accuracy of the test should meet the regulatory limits required for the particular application, improving the performance of conventional tests.
Ease of use. The test should be easy to perform by unskilled personnel after simple training.
Portable and durable. Testing should be performed in the field whenever possible.

Q: What is the difference between point of care and rapid test?

A: Point-of-care testing uses rapid diagnostic tests performed or interpreted by someone other than the individual being tested or their parent or guardian and can be performed in a variety of settings. Rapid tests used in point-of-care settings can be NAAT, antigen, or antibody tests.

Q: Why is PCR testing better than rapid testing?

A: Unlike the PCR test, the antigen test can only determine if you have an active virus in your body. The rapid test can't detect small amounts of the virus or asymptomatic cases as accurately as the PCR test can.The test only picks up if the virus is active in your body, meaning asymptomatic cases.

Q: What is COVID poct?

A: According to the CDC, Point-of-Care testing uses rapid diagnostic tests performed or interpreted by someone other than the individual being tested and can be performed in a variety of settings. Rapid tests used in point-of-care settings can be NAAT, antigen, or antibody tests.

Q: What are examples of POCT devices?

A: Examples of point of care testing devices include blood glucose monitors, urine dipsticks, and pregnancy tests. These devices are often useful when working with neonatal, pediatric, geriatric, and homebound patients.

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