Point of Care Testing

Access to rapid diagnostic results means appropriate treatment can be implemented quickly,
leading to an improved clinical or economic outcome.

Point of care testing (POCT) may be performed with or near to the patient, with the result being generated within a reasonable wait time. This means clinical decisions about next steps in the care of that patient, further tests or treatment pathways,
can be made very quickly.

POCTs are laboratory tests conducted outside of the laboratory, usually by appropriately trained non-laboratory staff. The tests can be performed in a range of locations such as the GP surgery, in A&E or in the community. A wide variety of people can perform point-of-care tests, including laboratory professionals, paramedics, radiologists, doctors, nurses, or other healthcare professionals. Some point-of-care tests may even be done by the patient. These tests are often referred to as "self-tests" or "home tests".

Although centralised laboratories offer a much wider range of tests and remain the mainstay of diagnostic testing, POCT can offer a rapid turnaround time with a potentially immediate impact on patient care.

Lateral Flow Assays

Lateral Flow Assays (LFAs) are commonly used in POCT. These simple devices can detect the presence of a target marker in a liquid sample such as blood, saliva, urine or a faecal sample extraction. They do not require specialist or costly equipment to perform the test or read the result. The tests are simple, economic and generally show results in around five to 30 minutes.

The image shows the principal of an LFA - specifically the IMMY Cryptococcal Antigen (CrAg) assay.

Typically, the LFA consists of a sample pad, a conjugate pad, a nitrocellulose strip that contains test and control line/s and a wicking pad.

The overlapping of each component enables smooth capillary flow of the sample. Once sample is applied on the adsorbent sample pad, it migrates to the conjugate release pad containing antibodies specific to the target analyte and conjugated to fluorescent or coloured particles, usually latex microspheres or colloidal gold.

The sample containing the conjugated antibody bound to the target analyte migrates along the strip into the detection zone that contains antibodies or antigens immobilised in lines. These components react with the analyte bound to the conjugated antibody. Positive test line indicates recognition of the sample analyte while the response on the control line demonstrates proper liquid flow through the strip. The intensity of the appearing lines can be assessed either by eye or using a dedicated reader. After the control line, the sample flows into the wicking pad which maintains the capillary force and the flow of the liquid.

Lateral flow assays may be in a dipstick format or housed in a cassette. Both dipsticks and casette tests work in a similar way.

Alpha Laboratories supports your Point of Care Testing requirements
with a range of assays for inflammation, bowel disease detection, therapeutic drug monitoring, infectious diseases and pregnancy testing.

Calprotectin POCT

The protein biomarker calprotectin is present in the faeces of a patient with intestinal inflammation. Testing for faecal calprotectin (fCAL) can screen out those with functional disorders such as Irritable Bowel Syndrome (IBS), from those with organic Inflammatory Bowel Disease (IBD). The symptoms of the two conditions can be very similar in presentation. Using this in vitro test initially prevents the need for unnecessary endoscopy procedures on many patients.

Measuring calprotectin levels in known IBD patients also helps manage their conditions by monitoring effectiveness of therapies and identifying potential relapse.

BÜHLMANN Quantum Blue®

Quantum Blue® fCAL assays are LFAs that use a faecal sample prepared in a CALEX extraction device to create a solution that can be used in lateral flow.

The quantitative results are read in the dedicated, compact and easy to use Quantum Blue reader. These results correlate with laboratory tests such as ELISA and turbidity assays.

Quantum Blue tests are also available for serum calprotectin (MRP8/14) which is a marker for rheumatoid arthritis.

In addition, a range of Quantum Blue Therapeutic Drug Monitoring assays for anti-inflammatory biologics, enable in-clinic assessment of patients immediately before the next dose of drug is administered.

BÜHLMANN IBDoc®

Under the guidance of clinicians, regular monitoring for IBD patients is now possible from the comfort of their own homes. Utilising sophisticated technology contained within smartphones to measure and transmit the results, the IBDoc enables patients to perform quantitative calprotectin tests themselves. This approach allows for a customised, patient centric method for therapy and disease management helping to predict possible relapse and assisting with therapy optimisation.

C-Reactive Protein (CRP)

CRP is produced by hepatocytes upon stimulation by the pro-inflammatory cytokines IL-1α, IL-6 and TNFα, so is useful as a marker for inflammation. In diagnostics CRP is often used to distinguish between viral and bacterial infections, as the amount of CRP increase is notably higher in bacterial infections. Often CRP is also determined to check for the success of a therapy, e.g. an antibiotic therapy. 

A Marker for IBD

CRP also supplements calprotectin as a reliable marker for the clinical course of inflammatory bowel disease (IBD), helping to predict relapses at the onset. The combination of the two markers has shown to increase the specificity for detecting inflammation in
Crohn’s disease.

DIAQUICK Assay

The CRP DIAQUICK Test Cassette immunochromatographic lateral flow assay provides semi-quantitative detection of C-Reactive Protein in whole blood, serum or plasma, manufactured by Dialab.

  • Read results within 5 minutes

  • 3 indicator lines to quantify the presence of CRP

  • Detection levels:   ≥ 10 mg/L, ≥ 40 mg/L and ≥ 80 mg/L

Therapeutic Drug Monitoring

The BÜHLMANN Quantum Blue® technology also offers rapid and reliable applications for therapeutic drug monitoring (TDM) of anti-inflammatory biologics. These provide powerful tools for immediate decision making in patient's treatment management.

Anti TNFα biologic drugs help ameliorate disease course and keep inflammations at remission levels for prolonged periods of time. However, patients with suboptimal drug concentrations have worse outcomes than those with adequate drug levels.  Therapeutic drug monitoring (TDM) for has a great potential for the management of anti TNF therapy.

Adalimumab and Infliximab Trough Levels

Studies have shown that targeting an adequate drug trough level can support guidance of treatment in IBD patients. An optimal therapeutic window for trough levels seem to be the range from 5 to 12 µg/ml for adalimumab and 3 to 7 µg/mL for infliximab in serum.

  • The Quantum Blue® Adalimumab assay measures from
    1.3 to 35 µg/ml

  • The Quantum Blue® Infliximab assay measures from
    0.4 to 20 µg/ml

  • Results in 15 minutes

Anti-Drug Antibody Detection

Patients with subtherapeutic or undetectable drug trough levels may exhibit the presence of anti-drug antibodies (ADA) which diminish the clinically beneficial effect of the drug. Fast detection of ADA supports guidance in the management of anti TNF therapy and allows for rapid adaptations in the treatment regime.

The drug-sensitive Quantum Blue® Anti-Infliximab and Anti- Adalimumab assays allow for a highly specific detection of antibodies
against the drugs

  • Results within 15 minutes

  • Ease of use and a short incubation time

  • Fast and reliable qualitative measurement of free anti-drug antibodies against the biologic drug

Faecal Occult Blood Testing

Qualitative faecal immunochemical tests (FIT) can be as easy as traditional guaiac methods for near patient testing or when the requirement for a fast turnaround impedes the use of a quantitative FIT service. 

No Dietary Assay Interference

It is common for guaiac-based methods to recommend adherence to a special diet in the days prior to testing. This is to avoid interference from peroxidases or animal haemoglobin, but is a distinct draw back when you need to test in an acute setting. There are no dietary restrictions when using the DIAQUICK FOB lateral flow assays, as these use antibodies that specifically bind human haemoglobin (Hb), with a sensitivity of 5µg Hb/g faeces.

The DIAQUICK FOB cassette offers the specificity of a FIT in a simple yes/no manual test format:

Specific, Sensitive, Simple

  • Easy to perform

  • Result in 5 minutes

  • Specific for human Hb

  • Sensitivity 5µg Hb/g faeces

  • No dietary preparation required

Infectious Diseases

Infectious diseases are transmissible or communicable illnesses and can spread quickly in some areas and become epidemics. It is critical to quickly diagnose initial bacterial, fungal or viral infections through in vitro diagnosis to prevent further spread . The LFA is the most popular diagnostic tool that meets the required standards for rapidly detecting the presence or absence of suspected infection.

Available assays include:

  • H. pylori, a common type of bacteria that can lead to  peptic ulcers and gastritis

  • Cryptococcus species, one of the most common HIV-related opportunistic infections

  • Aspergillus fungi commonly found in soil and dust that if inhaled can cause deadly infection in the immunocompromised

  • Viruses such as Infectious Mononucleosis

Pregnancy Testing

POCT for the detection of pregnancy and the prediction of ovulation has grown and evolved since the introduction of the first qualitative pregnancy test marketed directly to the consumer over four decades ago. 

Available assays include:

  • Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilisation.

    In normal pregnancy, hCG can be detected
    in serum, plasma and urine as early as 7 to 10 days
    after conception.

    The DIAQUICK hCG Combo Cassette produced by Dialab is for use with urine, serum or plasma samples.