Background Infection by Chlamydia trachomatis (CT) is the most prevalent sexually transmitted infection (STI) world wide. The most frequently used diagnostic test for CT is a nucleic acid amplification test (NAAT), which is highly sensitive and specific. To further shorten time delay until diagnosis has been made, in order to prevent CT spread, the use of point-of-care (POC) tests may be the way forward. Objectives The diagnostic performance of three POC tests, Handilab-C, Biorapid CHLAMYDIA Ag test and QuickVue Chlamydia test, was evaluated and compared with NAAT. Methods All women, above the age of 16 years, attending for a consultation at an STI clinic between September 2007 and April 2008, were asked to participate. Women were asked to complete a short questionnaire and to collect six self-taken vaginal swabs (SVS). SVS 2 was used for NAAT and SVS 3 to 5 were randomised for the different POC tests. SVS 1 and 6 were used for determining quantitative CT load to validate the use of successive SVS. All POC tests were performed without knowledge of NAAT results. NAAT was used as the 'gold standard'. Results 772 women were included. CT prevalence was 11% in our population. Sensitivities of the Biorapid CHLAMYDIA Ag test, QuickVue Chlamydia and Handilab-C test were 17%, 27% and 12%, respectively. Conclusions The evaluated POC tests, owing to their very low sensitivities, are not ready for widespread use. These results underline the need for good-quality assurance of POC tests, especially in view of the increased availability of these tests on the internet.
cWe validated the use of stored samples for Chlamydia trachomatis research. C. trachomatis DNA was detected by real-time PCR in clinical (urine and self-taken vaginal swabs) and spiked samples using six different media, five different time points (up to 2 years), and four different temperature conditions. C. trachomatis was detected in all 423 samples, and no clinically relevant degradation impact was detected. Chlamydia trachomatis is the most prevalent bacterial sexually transmitted microorganism worldwide. Many researchers conveniently use stored samples for their C. trachomatis research. In previous decades, the viability of C. trachomatis has been extensively explored using culture, and freezing samples appeared to be the most essential step in keeping C. trachomatis culturable (1, 2). The package insert of the COBAS TaqMan CT test (3), for instance, states that urine can be stored refrigerated or frozen for at maximum 7 and 30 days, respectively, before being processed. Swabs in transport medium can be stored at room temperature and frozen for, at maximum, 14 and 30 days, respectively, according to the package insert (3). The effect of different storage conditions on the load of C. trachomatis using nucleic acid amplification tests (NAAT), however, has never yet been thoroughly assessed in a clinical trial. We hypothesized that storage would not lead to false-negative NAAT results. Therefore, we assessed the impact of four different temperature conditions, six different types of medium, and five increasing lengths of duration of storage, up to 2 years, on C. trachomatis DNA detection.For this purpose, phosphate-buffered saline (PBS), 2-sucrosephosphate (2-SP) medium, COBAS Amplicor medium (Roche Diagnostics, Mannheim, Germany), and urine samples were spiked with the same amount of C. trachomatis serovar D elementary bodies (MyBioSource, San Diego, CA) and were stored at room temperature (RT), 4°C, Ϫ20°C, and Ϫ80°C, in triplicate. Samples were thawed only once, on the day of C. trachomatis DNA testing. Furthermore, clinical C. trachomatis-positive urine samples, as well as C. trachomatis-positive swabs in COBAS Amplicor medium, were collected, pooled, and stored in triplicate at the same four temperatures.Samples were tested in triplicate on day 0 and after 1, 7, 14, and 30 days and 2 years of storage (136 clinical and 287 spiked samples) for the presence of C. trachomatis DNA. DNA was isolated using the Qiagen DNA minikit (Qiagen GmbH, Hilden, Germany). For the real-time PCR targeting the cryptic plasmid as described by Jalal et al. (4), the total PCR volume was adjusted to 50 l. Also, only the inner primers were used, to avoid a nested PCR setup. For PCR amplification, an ABI 7900 HT real-time PCR machine (Applied Biosystems, Carlsbad, CA) was employed. Approximately 3,000 plasmids were available per PCR (e.g., per 20-l sample used in the PCR).Generalized linear models were used, controlling for repeated measurements. Models were run separately for the six evaluated modalities of samples. We tested whethe...
In Japan and Australia, multidrug-resistant Mycoplasma genitalium infections are reported with increasing frequency. Although macrolide-resistant M. genitalium strains are common in Europe and North America, fluoroquinolone-resistant strains are still exceptional. However, an increase of multidrug-resistant M. genitalium in Europe and America is to be expected. The aim of this paper is to increase awareness on the rising number of multidrug-resistant M. genitalium strains. Here, one of the first cases of infection with a genetically proven multidrug-resistant M. genitalium strain in Europe is described. The patient was a native Dutch 47-year-old male patient with urethritis. Mycoplasma genitalium was detected, but treatment failed with azithromycin, doxycycline and moxifloxacin. A urogenital sample was used to determine the sequence of the 23S rRNA, gyrA, gyrB and parC genes. The sample contained an A2059G single nucleotide polymorphism (SNP) in the 23S rRNA gene and an SNP in the parC gene, resulting in an amino acid change of Ser83 → Ile, explaining both azithromycin and moxifloxacin treatment failure. The SNPs associated with resistance were probably generated de novo, as a link with high-prevalence areas was not established. It is, thus, predictable that there is going to be an increase of multidrug-resistant M. genitalium strains in Europe. As treatment options for multidrug-resistant M. genitalium are limited, the treatment of M. genitalium infections needs to be carefully considered in order to limit the rapid increase of resistance to macrolides and fluoroquinolones.
The performance of both ELISA was excellent in our study and is favoured over the TPPA because of its ability to be run on an automated system. The sensitivity and specificity of the Biorapid Syphilis were considered too low to implement the test in a hospital laboratory in a developed country but it might be useful in primary healthcare settings in developing countries.
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