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PubMed2005

Positive control wells: a potential answer to remote-area quality assurance of malaria rapid diagnostic tests.

Malaria rapid diagnostic tests (RDTs) are a potential breakthrough in the provision of accurate diagnosis in remote areas, but widescale use is hampered by uncertainty over accuracy under field conditions. Positive control wells, which contain recombinant malaria parasite antigen, are a novel method for addressing this need for quality assurance. The potential of a commercially available positive control well, reconstituted with blood, was assessed for use in routine monitoring of RDT sensitivity in a remote malaria-endemic region. When maintained at 4 degrees C, the wells produced a consistent level of parasite lactate dehydrogenase (pLDH) antigen activity, as detected by pLDH-detecting RDTs, but activity reduced after cumulative exposure to temperatures likely to be encountered over a few months in a malaria-endemic area. This limitation was successfully overcome in the field through centralized, controlled storage. Monitoring of RDT sensitivity was successfully incorporated into routine supervisory visits to remote clinics. However, improved temperature stability of the wells would enhance their potential. The threshold at which the wells' signal reduced RDT sensitivity requires further investigation. The wells show potential to overcome an important obstacle to the wide implementation of accurate parasite-based diagnosis and appropriate treatment. Further assessment of their place in malaria management is warranted.

Diagnostic Tests, Routine↗

PubMed2007

The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests.

Malaria rapid diagnostic tests (RDTs) have performed well in a variety of studies, but recent reports have described sensitivity for Plasmodium falciparum as significantly lower than that required for operational deployment. Exposure to high temperature has been suggested as an explanation. This study assessed the temperature stability of two different Plasmodium lactate dehydrogenase (pLDH)- and three histidine-rich protein 2 (HRP2)-detecting RDTs. One HRP2 test proved insufficiently sensitive for assessment. After incubation at 35, 45 and 60 degrees C, two RDTs detecting pLDH showed a substantial fall in percentage test line positivity over time, which was not seen with the remaining two HRP-2-based RDTs. For the particular products studied, variability was high, with the pLDH-based RDTs being less sensitive than HRP2-based RDTs against the sample of P. falciparum used and more susceptible to heat-induced damage, but the reasons for this are unclear. The performance of malaria RDTs can be adversely affected at the temperatures to which they will be exposed when transported to, and used in, the rural tropics.

Animals↗

PubMed2004

Influenza virological surveillance in children: the use of the QuickVue rapid diagnostic test.

New rapid diagnostic methods are needed to identify influenza infections to improve virological surveillance usually undertaken with conventional time-consuming, complex, and even expensive laboratory methods. Another reason for using a rapid test is to avoid inappropriate therapy, particularly in children, where use of antibiotics inappropriately and high influenza-related rates of hospitalisation are described. During two winter seasons, the performance of the QuickVue Influenza test (QV) was evaluated in children under 14 presenting with influenza like illness, and compared the results with those obtained from sentinel network surveillance using standard protocols for the sample collection and the laboratory analysis by virus culture and reverse transcription-polymerase chain reaction (RT-PCR). During the first influenza season (2000/2001), 22 paediatricians collected one nose- and one throat-swab from each of the 586 children 0-6 years old recruited in the study. The QV test was carried out in the physician's office by primary care staff on the nose swab material. When compared with virus culture of the throat swab, the QV test had a sensitivity of 36.5%. In the following 2001/2002-influenza season, the performance of the QV test as a rapid laboratory screening assay was assessed. 342 children aged 0-14 years were enrolled with only one throat swab collected from each patient and sent to the laboratory where the QV, virus culture, and RT-PCR tests were performed. The results showed a better sensitivity (54.5%) of the test in comparison with virus culture and RT-PCR assays. The data indicate that rapid QV testing in the physician office setting, using these easily obtained samples, may be too insensitive to be useful for surveillance and for immediate clinical management of children presenting with influenza-like illness. Nevertheless, the QV test may be a valuable diagnostic tool if used in laboratory, as a rapid screening test.

Animals↗

PubMed2003

Algorithm to determine cost savings of targeting antimicrobial therapy based on results of rapid diagnostic testing.

A rapid diagnosis of pneumococcal pneumonia may allow the earlier use of narrow-spectrum antimicrobial therapy. It is unknown, however, whether rapid diagnostic testing of patients hospitalized with community-acquired pneumonia (CAP) admitted to hospital lowers costs. Therefore, an algorithm to calculate the costs associated with the diagnosis and treatment of CAP was formulated. Subsequently, the algorithm was applied to clinical data for 122 consecutively admitted patients with CAP whose sputum samples were Gram stained and whose urine was tested for Streptococcus pneumoniae antigen. The costs of initial antimicrobial therapy, personnel, and materials were measured. Compared to the most expensive empirical regimen, rapid diagnostic testing would result in cost savings per patient (PP) of 3.51 Euros for Gram staining and 8.11 Euros for urinary pneumococcal antigen testing (1 Euro is equal to 1.13 US dollars, from 2000 to 2002). Compared to the cheapest regimen, Gram staining would increase the cost by 2.25 Euros PP, and urinary antigen testing would increase the cost by 24.26 Euros PP. In our setting, the use of rapid diagnostic testing would not lower costs. Cost savings depend, however, on the differences in the prices of the different antibiotics chosen and the proportion of evaluable and positive samples.

Adult↗

PubMed1986

The Widal slide agglutination test, a valuable rapid diagnostic test in typhoid fever patients at the Infectious Diseases Hospital of Jakarta.

The Widal slide agglutination test was evaluated as a rapid diagnostic test in typhoid fever patients at the Infectious Diseases Hospital, Jakarta, Indonesia from 1980-1982. The results of the test can be available within 45 minutes of patient admission. The study showed that, among 229 patients with Salmonella typhi-positive typhoid fever and 179 control fever patients, when the Widal O antibody titer was greater than or equal to 1:20 the sensitivity was 53%, the specificity 98%, the positive predictive value 96%, and the negative predictive value 68%. A negative Widal test (O antibody titer less than 1:20) does not provide useful information, but when the O antibody titer is greater than or equal to 1:20 the clinician at the Infectious Diseases Hospital of Jakarta can be 96% certain that the patient has typhoid fever.

Adolescent↗

PubMed2003

Development and testing of a rapid diagnostic test for bubonic and pneumonic plague.

BACKGROUND: Plague is often fatal without prompt and appropriate treatment. It affects mainly poor and remote populations. Late diagnosis is one of the major causes of human death and spread of the disease, since it limits the effectiveness of control measures. We aimed to develop and assess a rapid diagnostic test (RDT) for plague. METHODS: We developed a test that used monoclonal antibodies to the F1 antigen of Yersinia pestis. Sensitivity and specificity were assessed with a range of bacterial cultures and clinical samples, and compared with findings from available ELISA and bacteriological tests for plague. Samples from patients thought to have plague were tested with the RDT in the laboratory and by health workers in 26 pilot sites in Madagascar. FINDINGS: The RDT detected concentrations of F1 antigen as low as 0.5 ng/mL in up to 15 min, and had a shelf life of 21 days at 60 degrees C. Its sensitivity and specificity were both 100%. RDT detected 41.6% and 31% more positive clinical specimens than did bacteriological methods and ELISA, respectively. The agreement rate between tests done at remote centres and in the laboratory was 89.8%. With the combination of bacteriological methods and F1 ELISA as reference standard, the positive and negative predictive values of the RDT were 90.6% and 86.7%, respectively. INTERPRETATION: Our RDT is a specific, sensitive, and reliable test that can easily be done by health workers at the patient's bedside, for the rapid diagnosis of pneumonic and bubonic plague. This test will be of key importance for the control of plague in endemic countries.

Antibodies, Monoclonal↗

PubMed1986

Clinically expedient reporting of rapid diagnostic test information.

With the development of rapid diagnostic tests in the clinical microbiology laboratory has come an awareness of the importance of rapid results reporting. Clearly, the potential clinical impact of rapid diagnostic tests is dependent on expeditious reporting. Traditional manual reporting systems are encumbered by the necessity of transcription of test information onto hard copy reports and then the subsequent distribution of such reports into the hands of the user. Laboratory computers when linked directly to CRTs located in nursing stations, ambulatory clinics, or physician's offices, both inside and outside of the hospital, permit essentially instantaneous transfer of test results from the laboratory to the clinician. Computer-assisted results reporting, while representing a significant advance over manual reporting systems is not, however, without problems. Concerns include validation of test information, authorization of users with access to test information, mechanical integrity, and cost. These issues notwithstanding, computerized results reporting will undoubtedly play a central role in optimizing the clinical impact of rapid diagnostic tests.

Clinical Laboratory Techniques↗

PubMed2006

Assessing the genetic diversity of the aldolase genes of Plasmodium falciparum and Plasmodium vivax and its potential effect on performance of aldolase-detecting rapid diagnostic tests.

Malaria-specific rapid diagnostic tests (RDTs) targeting aldolase show highly variable sensitivities. We assessed diversity in Plasmodium falciparum and P. vivax aldolases by sequencing the coding genes from parasites of various origins. The results show that aldolases are highly conserved, indicating that antigenic diversity is not a cause of variable RDT sensitivity.

Aldehyde-Lyases↗

PubMed2003

[Rapid diagnostic tests for influenza].

Rapid and accurate diagnosis is very important for the control of influenza, which is usually diagnosed on a clinical basis. Recently, some rapid diagnostic tests for detecting influenza viruses in respiratory specimens have become available and have proved to be clinically useful. The rapid confirmation of an influenza diagnosis enables prompt treatment with specific antiviral drugs and also decreases the use of unnecessary antibiotics. The rapid tests are also useful for detection of institutional influenza activity. It is important to understand the performance characteristics of the rapid tests.

Chromatography↗

PubMed2002

Clinical evaluation of the ZstatFlu-II test: a chemiluminescent rapid diagnostic test for influenza virus.

Exploiting the high sensitivity of the chemiluminescence phenomenon, an accurate and sensitive point-of-care test, called the ZstatFlu-II test (ZymeTx, Inc., Oklahoma City, Okla.), was developed to detect influenza virus infections. The ZstatFlu-II test takes 20 min and requires approximately 2 min of "hands-on" time for operational steps. The ZstatFlu-II test does not distinguish between infections with influenza virus types A and B. ZstatFlu-II test results are printed on Polaroid High-Speed Detector Film, allowing test results to be archived. A prototype version of the ZstatFlu-II test was evaluated during the 2000-to-2001 flu season with 300 nasal aspirate specimens from children at a pediatric hospital. Compared to culture, the ZstatFlu-II test had 88% sensitivity and 92% specificity. The Directigen test had a sensitivity of 75% and a specificity of 93%. The sensitivity of the ZstatFlu-II test was significantly higher than that of the Directigen test (P < 0.0574).

Adolescent↗

PubMed2026

Malaria rapid diagnostic tests: performance, pitfalls, and progress.

PURPOSE OF REVIEW: Malaria rapid diagnostic tests (RDTs) have revolutionized malaria diagnosis in endemic settings. RDTs are simple to use and accurate for clinical cases, although sensitivity is reduced at parasite densities below 200 parasites/μl. However, increasing prevalence of hrp2/3 gene deletions in certain areas threaten utility of histidine-rich protein 2 (HRP2)-based RDTs, and lingering HRP2 antigenemia can generate false-positive results after parasite clearance. This review summarizes current performance of malaria RDTs, threats to their validity, and recent innovations to improve their performance and continued role in malaria diagnosis. RECENT FINDINGS: Most World Health Organization (WHO) prequalified RDTs perform well for clinical diagnosis, with only occasional exceptions, including a recently reported issue affecting several countries. RDT sensitivity is generally related to malaria transmission intensity, with higher proportions of false-negative results in lower-transmission areas. Newly prequalified lactate dehydrogenase (pLDH)-based RDTs perform well for both Plasmodium falciparum in areas with >5% hrp2/3 gene deletions and for Plasmodium vivax diagnosis. Several point-of-care alternatives to RDTs, including micro-fluidic devices, hemozoin-detecting devices, and automated hematology analyzers, have shown promising results in small studies, but require larger-scale trials before widespread use. SUMMARY: RDTs remain a critical tool in clinical diagnosis of malaria, and newer pLDH-based tests perform well in areas where hrp2/3 gene deletions threaten validity of HRP2-based RDTs.

Humans↗

PubMed2003

Rapid diagnostic testing for malaria.

Malaria rapid diagnostic devices (MRDD) have been developed with the hope that they would offer accurate, reliable, rapid, cheap and easily available alternatives to traditional methods of malaria diagnosis. The results from early malaria rapid diagnostic studies were quite promising, especially for detecting Plasmodium falciparum at densities of more than 100-500 parasites/microl. Despite the introduction of these devices over a decade ago, only a few target antigens have been introduced. Of greater concern, these devices have shown limitations in sensitivity, ability to differentiate species and robustness under field conditions in the tropics. Recent trials have revealed wide variability in sensitivity both within and between products. We review the recent trials assessing MRDD use for the diagnosis of P. falciparum and non-P. falciparum infections in endemic and non-endemic countries and describe the various aspects of these devices which need further improvement. High quality, accurate, rapid and affordable diagnostic tools are urgently needed now that new antimalarial regimens, characterized by higher cost and increased toxicity, have been introduced more widely in response to emerging multi-drug resistance.

Animals↗

PubMed2002

[Practical evaluation of rapid diagnostic tests for mycobacteriosis and virus infection].

Because cultures of mycobacteria and viruses take a great number of days, the results are delayed in these clinical laboratory tests. For this reason, rapid diagnostic tests without these cultures are required. Among the laboratory tests of mycobacteria, acid-fast stain as a rapid diagnostic test is the first to give significant information to laboratory staffs and physicians. There are mainly two procedures, directly smearing clinical specimens and smearing concentrated specimens treated with NALC-NaOH on slide glass. The former is performed for specimens from emergency patients. When a patient is suspected of tuberculosis, a DNA-amplification test such as COBAS AMPLICOR TEST (PCR test) is performed for directly detecting Mycobacterium tuberculosis in clinical specimens, regardless of whether the specimens show positive or negative by acid-fast stain. Sixty-one of 1,023 specimens tested in Showa University Fujigaoka Hospital in February 2000-May 2002 were found positive by both PCR and culture tests. Fourteen were found negative by PCR test and positive by culture test. Five were found positive by PCR test and negative by culture test. Alternatively, MTB-64 (Capilia TB) is a kit for rapidly identifying M. tuberculosis using colonies. The time necessary for completion of the test was approximately 15 minutes per sample. In our study, the identification test showed weak-positive for 2 strains of M. marinum (ATCC927 and one clinical isolate), compared with positive for 28 clinical isolates and strain H37Ra of M. tuberculosis. Recently, rapid diagnostic kits for detecting various pathogenic viruses have been developed. The kits for detecting influenza virus are in especially great demand with the spread of newly-developed antiviral agents. There was an epidemic of the type A virus in the winters 2001-2002. 101 (32%) of 316 clinical specimens tested in the hospital were found positive with InfluA. B-Quick [SEIKEN] (Denka) or Directigen Flu A (Becton Dickinson). These kits showed high utility. Also, Abbot TESTPACK RSV (Dainabot) for detecting RS virus and ROTALEX DRY (Orion Diagnostica) for detecting rotavirus showed high utility. However, these rapid diagnostic kits have weak points: high costs, false positives and false negatives. Thus, more improvements are required.

Bacteriological Techniques↗

PubMed2005

Field evaluation of malaria rapid diagnostic tests for the diagnosis of P. falciparum and non-P. falciparum infections.

The objective of this study was to evaluate various malaria rapid diagnostic tests as a tool in the detection of P. falciparum and non-P. falciparum infections in field conditions. Four field surveys were conducted in malaria-endemic areas of Palawan and Davao del Norte, Philippines to validate the various rapid diagnostic tests, namely Diamed OptiMAL 48 (DiaMed AG, Switzerland), ParaHIT f (Span Diagnostics, India), Orchid OptiMAL, and Paracheck Pf (both from Orchid Biomedical Systems, India). The results of the various rapid diagnostic tests were compared to those of microscopy. Sensitivity, specificity and detection rates according to the level of parasitemia were used as parameters to describe the performance of the various rapid diagnostic tests in the field. Practical and operational assessments were also done. The results of the study show that the sensitivity and detection rates were generally lower than previously reported, with sensitivities ranging from 4.8% to 20.6%, except for Diamed OptiMAL 48, which had sensitivities of 78.8% to 96.8%, and detection rates of 50.0% to 96.8%. The rest had detection rates ranging from 0.0% to 50.0%. All the specificities ranged from 18.2% to 100.0%. Improper conditions at the time of manufacturing, storage, transport, and utilization may affect the validity of the results. Rapid diagnostic tests for malaria provide practical means of detecting malarial infections, especially in endemic areas. However, issues regarding variability in performance must to be addressed before they can be used as mainstream diagnostic tools.

Algorithms↗

PubMed2002

Evaluation of the ICT malaria P.f/P.v and the OptiMal rapid diagnostic tests for malaria in febrile returned travellers.

Rapid diagnostic tests (RDTs) are less reliant on expert microscopy and have the potential to reduce errors in malaria diagnosis but have not been extensively evaluated in nonimmune persons or in countries where infection is not endemic. We evaluated the ICT P.f/P.v (ICT-Amrad, Sydney, Australia) and OptiMal (Flow Inc., Portland, Oreg.) assays prospectively for the diagnosis of malaria in 158 specimens from 144 febrile returned travellers in Australia by using expert microscopy and PCR as reference standards. Malaria was diagnosed in 93 specimens from 87 patients by expert microscopy, with 3 additional specimens from recently treated patients testing positive for Plasmodium falciparum by PCR. For the diagnosis of asexual-stage P. falciparum malaria, the sensitivity and specificity of the ICT P.f/P.v assay were 97 and 90%, respectively, and those of the OptiMal assay were 85 and 96%, respectively. The ICT P.f/P.v assay missed one infection with a density of 45 parasites/ micro l, whereas the OptiMal assay missed infections up to 2,500/ micro l; below 1,000/ micro l, its sensitivity was only 43%. For the diagnosis of P. vivax malaria, the sensitivity and specificity of the ICT P.f/P.v assay were 44 and 100%, respectively, and those of the OptiMal assay were 80 and 97%, respectively. Both assays missed infections with parasite densities over 5,000/ micro l: up to 10,000/ micro l with the former and 5,300/ micro l with the latter. Despite the high sensitivity of the ICT P.f/P.v assay for P. falciparum malaria, caution is warranted before RDTs are widely adopted for the diagnosis of malaria in nonimmune patients or in countries where malaria is not endemic.

Animals↗

PubMed2006

Evaluation of a new recombinant K39 rapid diagnostic test for Sudanese visceral leishmaniasis.

A new rK39 rapid diagnostic dipstick test (DiaMed-IT-Leish) was compared with aspiration and a direct agglutination test (DAT) for diagnosis of visceral leishmaniasis (VL) in 201 parasitologically confirmed cases, 133 endemic controls, and in 356 clinical suspects in disease-endemic and -epidemic areas in Sudan. The sensitivity of the rK39 test in parasitologically confirmed VL cases was 90%, whereas the specificity in disease-endemic controls was 99%. The sensitivity of the DAT was 98%. In clinically suspected cases, the sensitivity of the rK39 test was 81% and the specificity was 97%. When compared with the diagnostic protocol based on the DAT and aspiration used by Médecins sans Frontières in epidemic situations, the positive predictive value was 98%, and the negative predictive value was 71%. This rK39 rapid diagnostic test is suitable for screening as well as diagnosis of VL. Further diagnostic work-up of dipstick-negative patients with clinically suspected VL is important. The ease and convenience of the dipstick test will allow decentralization and improved access to care in disease-endemic areas in Sudan.

Antigens, Protozoan↗

PubMed1996

Evaluation of a rapid diagnostic test for bacterial vaginosis.

OBJECTIVE: To evaluate a new rapid diagnostic test for bacterial vaginosis. DESIGN: Comparison of a new biochemical diamine test with low technology tests and microbiological culture. SETTING: General practice, family planning clinic. MAIN OUTCOME MEASURES: Comparison of the new diamine test with microbiological culture for Gardnerella vaginalis, with clue cells, and with the amine test. RESULTS: Two hundred and twenty-nine vaginal swabs were assayed quantitatively by the new diamine test. When compared with microbiological culture of Gardnerella vaginalis, the sensitivities and specificities were 86% and 81%, respectively. When compared with clue cell findings, the sensitivities and specificities were 97% and 83%, respectively. In the third comparison with the amine test the sensitivity was 94% and the specificity was 84%. Since microbiological diagnosis of organisms related to bacterial vaginosis is difficult, the new test and existing sideroom tests may be more sensitive to the condition and the true frequency of false positives may be less than the specificity in this study suggests. CONCLUSIONS: The new diamine test is accurate, sensitive and specific, and provides the basis for the rapid diagnosis of bacterial vaginosis. Such a test is needed if bacterial vaginosis is to be diagnosed and managed effectively in both general and specialist practice.

Adolescent↗

PubMed1983

Rapid diagnostic tests for glucosuria are still influenced by ascorbic acid.

The influence of ascorbic acid on commercial rapid diagnostic tests for glucosuria is demonstrated in vitro. Although much work has been done to stabilize the tests against such interference, and although manufacturers of tests trips declare their products now to be fairly stable against ascorbic acid 'at higher glucose levels', all the investigated commercial rapid diagnostic tests for glucose at the lower pathological range of glucosuria were substantially influenced by ascorbic acid at potentially physiological concentrations.

Ascorbic Acid↗