REVIEW
10.1111/j.1469-0691.2010.03281.x
Routine use of point-of-care tests: usefulness and application in clinical microbiology O. Clerc1 and G. Greub1,2 1) Infectious Diseases Service and 2) Institute of Microbiology, University Hospital Centre and University of Lausanne, Lausanne, Switzerland
Abstract Point-of-care (POC) tests offer potentially substantial benefits for the management of infectious diseases, mainly by shortening the time to result and by making the test available at the bedside or at remote care centres. Commercial POC tests are already widely available for the diagnosis of bacterial and viral infections and for parasitic diseases, including malaria. Infectious diseases specialists and clinical microbiologists should be aware of the indications and limitations of each rapid test, so that they can use them appropriately and correctly interpret their results. The clinical applications and performance of the most relevant and commonly used POC tests are reviewed. Some of these tests exhibit insufficient sensitivity, and should therefore be coupled to confirmatory tests when the results are negative (e.g. Streptococcus pyogenes rapid antigen detection test), whereas the results of others need to be confirmed when positive (e.g. malaria). New molecular-based tests exhibit better sensitivity and specificity than former immunochromatographic assays (e.g. Streptococcus agalactiae detection). In the coming years, further evolution of POC tests may lead to new diagnostic approaches, such as panel testing, targeting not just a single pathogen, but all possible agents suspected in a specific clinical setting. To reach this goal, the development of serology-based and/or molecular-based microarrays/multiplexed tests will be needed. The availability of modern technology and new microfluidic devices will provide clinical microbiologists with the opportunity to be back at the bedside, proposing a large variety of POC tests that will allow quicker diagnosis and improved patient care. Keywords: Chlamydia rapid detection test, group A/B streptococci tests, malaria rapid test, point-of-care tests, review, urinary antigen tests Clin Microbiol Infect 2010; 16: 1054–1061
Corresponding author and reprint requests: G. Greub, Infectious Diseases Service and Institute of Microbiology, University Hospital Centre and University of Lausanne, Lausanne, Switzerland E-mail:
[email protected]
Introduction Point-of-care (POC) tests are laboratory tests designed to be used directly at the site of patient care, which may comprise physicians’ offices, outpatient clinics, intensive-care units, emergency rooms, hospital laboratories, and even patients’ homes. Such broad availability of diagnostic tests needs systems that are accessible to personnel without specific laboratory medicine training, and allows quicker delivery of results that directly influence the clinical decision [1]. Such tests have become the standard of care for critically ill patients, allowing bedside evaluation of vital parameters such as blood gases or glycaemic control [2]. In the last 20 years, the availability and use of POC tests have greatly increased and expanded to all fields of medicine, so that a significant proportion of laboratory testing is currently conducted at the point of care [1–3]. In the setting of infectious diseases,
most existing POC tests consist of immunoassays, namely agglutination, immunochromatographic and immunofiltration tests [4] (Table 1). Some non-immunological POC tests based on nucleic acid detection are already available for a few organisms, and might represent a major advance in the coming years, with automation and generalization of these technically demanding diagnostic approaches. The decrease in analytical time in comparison with standard microbiological procedures offers potentially substantial benefits for the management of infectious diseases. Thus, immediate identification of a specific pathogen allows the use of adequate empirical therapy, which has been shown to improve the outcome in critically ill patients [5,6]. Similarly, in cases of particular clinical syndromes such as lower respiratory tract infections, POC tests may help to quickly identify situations where antibacterial therapy is relevant [7]. Conversely, the rapid diagnosis of viral infections such as influenza can limit the prescription of antibacterial therapy
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TABLE 1. Indication and performances of commonly used point-of-care (POC) tests Test/pathogen
Type of test
Sample
Indication
Performances
Comment
Ref.
Group A streptococcal rapid test
EIA
Pharyngeal swab
Sore throat
Sensitivity: 53–99% Specificity: 62–100%
[19]
Pneumococcal antigen
ICT
Legionella antigen
ICT
Urine (pleural fluid, CSF) Urine
Group B streptococci
POC test–PCR POC test–PCR
Vaginal swab
Severe pneumonia (empyema, meningitis) Severe pneumonia/risk factors for legionellosis Peripartum detection of colonization Risk factors, screening
Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity:
66–70% 90–100% 76% 99% 94–97% 96–100% 86–94% 93–95%
Confirmation of negative swabs with culture may be unnecessary for adults Better sensitivity for severe and bacteraemic pneumonias Only serotype 1 reliably detected
[41,42]
Clostridium difficile toxin detection Chlamydia antigen
ICT
Stool
ICT ICT
Giardia lamblia rapid diagnosis RSV antigen
EIA
Stool
ICT
Influenza rapid test
ICT
Rotavirus antigen
ICT
Nasopharyngeal swab Nasopharyngeal swab Stool
Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity: Sensitivity: Specificity:
49–80% 95–96% 83% 99% 87–100% 52–100% 58–98% 97–98% 59–97% 75–100% 20–55% 99% 75–99% 95% 22% 84% 99–100% 99–100% 97% 100%
May lead to treat more infected patients Sensitivity better for Plasmodium falciparum (panmalarial tests) May perform comparably to microscopic examination of stools Lower viral load explains poorer performance in adults Low sensitivity; probably not helpful during outbreaks; lower in adults May be coupled with adenovirus detection Poor performance
[48]
Rapid malaria test
Vaginal swab, urine Blood
Antibiotic-associated diarrhoea Screening, suspicion of PID
Performs better than late antenatal screening PCR-positive and culture-negative samples consistent with many circumstances Notably less sensitive than cultures
Performance comparable to standard tests Allows rapid discharge of positive patients
[66]
MRSA carriage detection
Nasal swab
Fever in returning traveller Diarrhoea, especially for returning travellers Viral symptoms, especially during the winter season Flu-like symptoms Diarrhoea (children)
Adenovirus antigen
ICT
Stool
Diarrhoea
HIV rapid test
ICT
Blood (oral fluid)
Enterovirus
POC test–PCR
CSF
Screening, prevention of vertical transmission Meningitis
[25–27] [34]
[57]
[58,59]
[54,55] [60,61] [62] [12,63] [64,65] [65]
[9,67]
CSF, cerebrospinal fluid; EIA, enzyme immunoassay; HIV, human immunodeficiency virus; ICT, immunochromatographic test; MRSA, methicillin-resistant Staphylococcus aureus; PID, pelvic inflammatory disease; RSV, respiratory syncytial virus.
and the need for additional tests [8]. Documentation in cerebrospinal fluid of enteroviral RNA has clearly modified the management of a given patient with meningitis, in terms of prescription of antibacterial agents, investigations, and duration of hospitalization [9]. Thus, POC tests might help to limit the overuse of antibiotics, prevent the emergence of resistance, and be cost-effective in reducing the charges associated with diagnostic procedures and hospitalization. Furthermore, the rapid documentation of a transmissible agent at admission lowers the risk of its nosocomial transmission [10]. In situations where immediate treatment is recommended to interrupt further transmission and when patients might not return for follow-up, such as for genital ulcers of sexually transmitted diseases [11], the development of POC tests may allow clinicians to better curtail the empirical therapy, thus limiting toxicity and costs of unnecessary treatments, and to obtain better compliance with treatment. POC tests need easily obtained samples such as urine, blood, saliva, or nasopharyngeal swabs. Although the use of these tests does not require laboratory personnel, performance is clearly linked to the experience of the operator [12,13], which may influence the test’s accuracy. POC test analytical errors have been described as relatively common, and might impair patient care [14]. POC tests are usually evaluated in comparison with standard microbiological
procedures, sometimes being performed concomitantly, and their analytical characteristics are variable (Table 1). The clinician should be fully aware of the limitations of each test, and in taking the decision to use POC tests, must take into account the clinical setting and patient characteristics such as age, sex, comorbidities, and medical history. The traceability and general accessibility of results might be impaired if interfacing with traditional informatics systems is not considered, and this could lead to loss of data and difficulties with the necessary quality controls [15]. In this review, we present the characteristics of a few selected POC tests, illustrating the clinical impact of such assays in the field of clinical microbiology and infectious diseases, and highlighting some of the limitations that clinicians should take into account in order to use them appropriately.
Group A Streptococcal Rapid Test Sore throat is a common reason for consulting paediatricians and primary-care physicians. Most cases are of viral origin [16]. Group A streptococcus is the most frequent aetiology of bacterial pharyngitis, and may cause 5–10% of pharyngitis cases in adults and up to 30% of pharyngitis cases in paediatric patients [17]. Antibiotic therapy is mainly aimed at
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preventing acute rheumatic fever and suppurative complications such as peritonsillar abscesses [17]. Although clinical scores have been used to estimate the probability of streptococcal pharyngitis [18], microbiological assays are needed, as clinical presentation alone does not allow clinicians to reliably discriminate bacterial and viral aetiologies. Throat swab culture on a blood agar plate remains the reference standard. Since the 1980s, several rapid tests targeting the group A carbohydrate antigen of Streptococcus pyogenes have been developed. The first assays using agglutination techniques were replaced by enzyme immunoassays and, more recently, immunochromatographic tests, with a concomitant increase in sensitivity [19] (Table 1). Despite the relative simplicity of these tests, sensitivity has been linked to the experience of the operator [13]. False-negative rapid test results are not systematically explainable by low-level carriage of streptococci [20]. The excellent specificity, commonly higher than 95% [19], allows treatment to be started in the case of a positive test result. Further benefits of immediate-onset antibiotic therapy are an earlier decrease in infectivity and a probable reduction in suppurative complications or at least in their severity [17]. Thus, although the cost of immunochromatography may be slightly higher than that of culture, this POC test is considered to be cost-effective. No further decrease in the acute rheumatic fever rate is expected with rapid tests, as antibiotic therapy may be safely delayed until 9 days after symptom onset [19]. The wide availability of rapid streptococcal tests has led to a substantial reduction in antibiotic prescriptions as compared with the period before their implementation [21], thus potentially contributing to prevention of the emergence of antibiotic resistance. Current recommendations advise confirmation of a negative test result with agar plate cultures, at least for children [17]. The lower frequency of streptococcal pharyngitis and the rarity of acute rheumatic fever in adults may lead to avoid performing culture in this subgroup of patients, at least when the pretest probability of bacterial pharyngitis is low [18]. Not performing cultures implies a loss of follow-up for antibiotic resistance, which is currently not relevant for penicillin, but is an emerging issue for macrolides [22]. Moreover, the aetiological agent of pharyngitis will not be identified if it is a less common agent, such as group B or group G streptococcus.
Pneumococcal Urinary Antigen Test Community-acquired pneumonia (CAP) is a common disease, and represents the most frequent infectious cause of mortality in industrialized countries. The aetiology of CAP frequently remains undetermined, mainly because of the broad
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differential diagnosis and the low yield of standard microbiological tests (i.e. sputum examination and culture, and blood cultures). Severe CAP generally justifies a more extensive attempt at aetiological diagnosis [23]. The availability of POC tests may allow clinicians to safely restrict their initial empirical therapy and so help to prevent unnecessary antibiotic use contributing to resistance. Streptococcus pneumoniae is the most frequently documented agent of CAP, and may represent a major cause of pneumonia of undetermined origin [23,24]. An immunochromatographic assay detecting the C-polysaccharide common to the cell walls of all pneumococcal serotypes was approved by the FDA in 1999. The availability of the result in 15 min offers a diagnostic alternative, especially when good-quality sputum cannot be obtained. The sensitivity of this assay was investigated against standard microbiological cultures of lower respiratory tract samples and blood cultures, and ranges from 66% to 70% [25,26], increasing in a setting of severe/bacteraemic pneumonia to 80–94% [25,27]. Although a high specificity of 90–100% has been demonstrated [25– 27], as many as 21% of healthy children younger than 12 months of age present with a positive urinary antigen, correlating with nasopharyngeal pneumococcal carriage [28]. As urinary antigen excretion may persist for up to 6 months after a documented episode of pneumococcal pneumonia [29], a previous pulmonary infection must be sought in the medical history to interpret the assay. Although this urinary antigen test will obviously not replace standard microbiological tests, in particular for assessment of antibiotic resistance of S. pneumoniae, the documentation of a pneumococcal pneumonia with the use of this POC test may allow clinicians to restrict empirical therapy [7]. The urinary antigen could be particularly useful when sputum is not available or for severe CAP, as it can detect as many as one-fourth more cases than Gram staining [25]. Pneumococcal antigen detection may be applied with acceptable performance to other clinical samples, such as pleural effusion or cerebrospinal fluid, where S. pneumoniae is also a frequent pathogen [30,31].
Legionella Urinary Antigen Test Legionella pneumophila was first recognized in 1976 in the setting of a localized major outbreak. Standard cultures for diagnosis of this fastidious organism usually need 2–7 days, and seroconversion may take several weeks [32]. Soon after recognition of the organism, diagnostic tests based on specific detection of a lipopolysaccharide portion of Legionella cell wall antigen in urine became available [32]. The broad use of
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such assays transformed the diagnosis of the disease, allowing rapid detection of the pathogen, as early as 1 day after onset of symptoms. This easier diagnosis may contribute to the observed global increase in the incidence of legionellosis: cases detected by the urinary antigen increased from 15% in 1995 to 33% in 1998, and to more than 90% in 2006 [33]. Importantly, this assay only reliably detects serogroup 1, which is responsible for about 90% of all cases in America and Europe [32]. Performance of this test was evaluated in a recent meta-analysis [34]. Although an excellent specificity of 99% has been demonstrated, the sensitivity of this POC test is lower than that of lower respiratory tract culture, at about 76%. Thus, in clinical practice, a negative urinary antigen result does not definitively exclude an L. pneumophila infection. Conversely, a positive test result is usually diagnostic, despite possible prolonged antigen excretion for several months, especially in immunosuppressed patients with a longer time to defervescence [35]. Recent guidelines recommend the use of this POC test in a setting of severe pneumonia and specific risk factors such as alcohol abuse and recent travel [23]. A rapid aetiological diagnosis may decrease mortality by allowing adequate initial treatment [6,36], although coverage of Legionella is necessary for severe CAP, even when the urinary test result is negative [23]. A positive impact in lowering the case-fatality rate in the setting of L. pneumophila outbreaks has also been suggested [37].
Detection of Group B Streptococci Group B streptococcal (GBS) disease is a leading cause of neonatal morbidity and mortality; rectal and/or vaginal colonization of the mother may lead to vertical transmission of Streptococcus agalactiae to the newborn during labour [38]. Early-onset neonatal disease is efficiently prevented by intrapartum antibiotics [39]. Although classical risk factors such as intrapartum fever, preterm delivery and prolonged membrane rupture have been recognized [38], the optimal screening approach is still a matter of debate. Guidelines from the CDC advise systematic screening during the late antepartum period (35–37 weeks) [40]. Peripartum administration of antibiotic prophylaxis is recommended for carriers. A risk-based approach is reserved for unscreened women in labour [39]. As colonization is often transient, the sensitivity of late antenatal cultures remains inferior to that of screening during labour. Consequently, the majority of early-onset GBS disease occurs in newborns of mothers with negative antenatal cultures and no risk factors [41]. Furthermore, preterm deliveries, which classically present a higher risk of
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GBS disease, do not benefit from this screening. Given the potentially low compliance with antepartum screening and difficulties with its practical application, there is obvious interest in a POC test for the immediate peripartum period. Rapid tests using antigen detection have been available for years; none of them showed sufficient sensitivity as compared with concomitant culture to safely allow a therapeutic decision at the time of delivery [42]. Automation of real-time PCR-based assays progressively led to a broader availability of rapid methods with a sensitivity close to 100% [41,42]. Thus, although the feasibility of broad implementation of PCR-based POC tests has still to be demonstrated, they may contribute to further reducing the incidence of early-onset GBS neonatal disease. The common use of these new-generation POC tests will not completely replace culture, as antibiotic susceptibility testing will still be needed, at least for patients with severe b-lactam allergy, for whom macrolides and clindamycin represent the best treatment options. Indeed, although group B streptococci are consistently sensitive to penicillin, resistance to these alternative treatments is increasing [43].
POC Test for Chlamydia trachomatis Infection C. trachomatis is the most common bacterial sexually transmitted disease worldwide. Most infected patients remain asymptomatic, and high rates of infection have been observed in women from several European settings [44]. Systematic screening programmes or detection based on risk factors may decrease disease transmission and prevent longterm complications, which mainly include pelvic inflammatory disease, subsequent infertility, ectopic pregnancy, and miscarriage [45]. A role in male infertility is also accepted [46]. Molecular amplification tests replaced culture of urethral/cervical swabs as the diagnostic reference standard because of their higher sensitivity and better acceptability when performed on urine samples [47]. Thus, the observed increasing incidence might be, in part, a result of more efficient screening [48]. However, molecular diagnosis remains expensive, and the delay before results are available implies a second visit for the initiation of treatment. This second appointment may often be missed, leaving numerous infected patients untreated. On the other side, the high frequency of asymptomatic infections makes microbiological diagnosis necessary before empirical therapy. In this setting, a POC test would have a major impact, allowing patients to receive diagnosis and treatment during the same consultation. Previously developed immunoassay-
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based rapid tests had shown poor sensitivity relative to nucleic acid amplification tests [48]. Despite inferior performance, rapid tests might paradoxically lead to the treatment of more infected patients, in settings where the return rate for results is low, and limit the risk of ongoing transmission until treatment [49]. Recently, the availability of a new generation of rapid tests demonstrating higher sensitivity, approaching that of PCR-based assays, brought hope for a better yield of screening, both in industrialized and in lowincome countries [48]. Automation of current real-time PCR assays [50] may lead to the future availability of new-generation, nucleic acid-based POC tests, allowing optimal management of infected patient with a same-day screening strategy. FIG. 1. Three examples of a malaria rapid immunochromatographic
Malaria Rapid Tests
test, in which results are weakly positive (left), clearly positive (middle), and negative (right). C, positive control band; P, Plasmodium species band; Pf, specific P. falciparum band.
Malaria remains a leading cause of death among infectious diseases worldwide, and one of the most severe causes of fever for travellers returning from endemic areas. The clinical presentation is notably protean, and key symptoms such as fever and chills might be missing in a substantial proportion of patients [51]. Thus, about 60% of cases are initially misdiagnosed in North America [52]. Malaria leads to death for about 1% of affected travellers, and many of these fatal evolutions might have been prevented in non-immune subjects, especially if treatment had been promptly initiated [51]. A diagnostic assay is therefore needed in the setting of the broad differential diagnosis and the possibility of co-infections. Careful examination of Giemsa thick blood smears is still considered to be the reference standard for malaria diagnosis. Although it is relatively inexpensive, reliable diagnosis of malaria by microscopy needs skill and experience; furthermore, it is rarely available in emergency rooms of non-endemic countries, where expertise may be lacking, and it may take a few hours for results to become available [53]. In recent years, rapid diagnostic techniques have been developed in response to these limitations. These immunochromatographic methods, introduced in the 1990s, target antigens that are specific to one species, such as histidinerich protein 2 for Plasmodium falciparum, and/or pan-Plasmodium antigens such as lactate dehydrogenase or aldolase [54] (Fig. 1). When compared to microscopic evaluation as the reference standard, these rapid tests, which deliver results in about 15 min, show encouraging results. Sensitivity, which may vary with the level of parasitaemia, is usually higher than 90%, especially for P. falciparum, the clinically most relevant Plasmodium species [54,55]. Recent findings suggest that rapid tests might perform better than microscopy in non-endemic countries, with PCR-based diagnosis as the reference
standard [56]. The equal performance with finger sticks and venous samples further supports their use as POC tests. As histidine-rich protein 2 antigen may persist for more than 1 month after cure of malaria [54], the value of a positive test result is difficult to evaluate in hyperendemic settings or in cases of low-grade parasitaemia in semi-immune patients. False-positive test results are also classically described with rheumatoid factor [54]. In non-endemic countries and for the diagnosis of febrile returning travellers, false-positive results remain rare. Conversely, the negative likelihood ratio in such settings may reasonably exclude the diagnosis of P. falciparum malaria in emergency rooms [55]. Nevertheless, rapid tests do not allow reliable quantification of antigen amount, and so cannot replace microscopic evaluation for the assessment of parasitaemia and therapeutic response [54].
Conclusions and Future Prospects Placing diagnostic tools directly in the hands of clinicians has demonstrated significant practical benefits for many different infectious diseases, and dramatically improved the diagnosis of specific pathogens. Faster availability of results may lead to better clinical outcomes, owing to immediate targeted treatments and reduced use of combined empirical antibiotic therapy, thus contributing to limiting the side effects and potentially preventing the emergence of resistance. Thank to ongoing developments, the impact of POC tests in clinical practice will further increase within the coming years, especially in the management of pathogens that are poorly detected with conventional microbiology approaches. More
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Transparency Declaration Both authors declare no conflicting interests.
References
FIG. 2. Schema of practical point-of-care test (POCT) use.
importantly than for classical diagnostic methods, knowledge and consideration of POC test characteristics in a specific clinical setting are mandatory to allow the rational use of such assays (Fig. 2). As POC test use may occur in parallel with conventional microbiology, demonstration of a clinically favourable impact should be coupled with a strict evaluation of the cost-effectiveness in the current setting of healthcare resource rationalization. POC tests evolved in parallel with the conventional diagnostic assays, and now also tend to include nucleic acid technology. Concomitantly, the definition of a POC test has progressively broadened, to include tests not formally designed for bedside use, but whose automation has allowed the transfer of complex technology from classical laboratories to sites of diagnosis and treatment, mirroring the former spread of blood gase analysers in intensive-care units. The eventual generalization of this new generation of POC tests could potentially limit the impact of the operator on performance, and enable the tests to achieve diagnostic yields closer to those standard microbiological assays. This automation may overcome the previously common loss of traceability, and allow the inclusion of POC test results in databases consulted by clinicians, using computerized connections. In the coming years, further evolution of POC tests may lead to new diagnostic approaches, such as panel testing, targeting not just a single pathogen but all possible agents suspected in a specific clinical setting. To achieve this goal, the development of serology-based and/or molecular-based microarrays/multiplexed tests will be needed. Technically, the availability of modern technology, combining new microfluidic devices with improved tests, will soon offer the opportunity to clinical microbiologists to be back at the bedside, proposing a new variety of POC tests that will allow quicker diagnosis and improved patient care.
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