BACKGROUND: In case of pneumonia, some biological findings are suggestive for Legionnaire\'s disease (LD) including C-reactive protein (CRP). A low level of CRP is predictive for negative Legionella Urinary-Antigen-Test (L-UAT).
METHODS: Observational retrospective study in Nord-Franche-Comté Hospital with external validation in Besançon University Hospital, France which included all adults with L-UAT performed during January 2018 to December 2022. The objective was to determine CRP optimal threshold to predict a L-UAT negative result.
RESULTS: URINELLA included 5051 patients (83 with positive L-UAT). CRP optimal threshold was 131.9 mg/L, with a negative predictive value (NPV) at 100%, sensitivity at 100% and specificity at 58.0%. The AUC of the ROC-Curve was at 88.7% (95% CI, 86.3-91.1). External validation in Besançon Hospital patients showed an AUC at 89.8% (95% CI, 85.5-94.1) and NPV, sensitivity and specificity was respectively 99.9%, 97.6% and 59.1% for a CRP threshold at 131.9 mg/L; after exclusion of immunosuppressed patients, index sensitivity and NPV reached also 100%.
CONCLUSIONS: In case of pneumonia suspicion with a CRP level under 130 mg/L (independently of the severity) L-UAT is useless in immunocompetent patients with a NPV at 100%. We must remain cautious in patients with symptoms onset less than 48 h before CRP dosage.

A 79-year-old man presented with chest pain, and urinary antigen tests for Legionella pneumophila (ImmunoCatch® Legionella and Ribotest® Legionella) were negative on admission. The next day, rapid respiratory failure suggested Legionella pneumonia, and levofloxacin was added. Since a lung infiltration shadow appeared on the other side as well on day 4, non-infectious diseases were considered, and steroid therapy was started. Urinary antigen tests for Legionella pneumophila became positive on day 5. In the present case, retesting with Ribotest® Legionella, which could be negative early after the disease onset, was useful for diagnosing Legionella pneumonia, which led to the discontinuation of unnecessary steroid treatment.

Pneumonia is a leading cause of hospitalization and death due to infection worldwide. Streptococcus pneumoniae and Legionella pneumophila remain among the most commonly identified bacterial pathogens. Unfortunately, more than half of all pneumonia cases today lack an etiologic diagnosis due to limitations in traditional microbiological methods like blood and sputum cultures, which are affected by poor sample collection, prior antibiotic administration, and delayed processing. Urinary antigen tests (UATs) for S. pneumoniae and L. pneumophila have emerged as powerful tools for improving the diagnosis of bacterial respiratory infections, enabling physicians to administer early directed therapy and improve antimicrobial stewardship. UATs are simple, rapid, and non-invasive diagnostic tests with high specificity (>90%) and moderate sensitivity (<80%). The potential impact of urinary antigen testing is especially significant for respiratory infections caused by Legionella. While all recommended community-acquired pneumonia (CAP) therapies are adequate for treating pneumococcal pneumonia, only certain antibiotics are effective against Legionella. Delayed therapy for Legionella is associated with worse clinical outcomes, which underscores the importance of rapid diagnostic methods like UATs. Despite their potential impact, current American Thoracic Society and Infectious Diseases Society of America (ATS/IDSA) guidelines argue against the routine use of urinary antigen testing for S. pneumoniae and L. pneumophila, except in patients with severe CAP and those with epidemiological risk factors for Legionella. Further research is necessary to evaluate the impact of early targeted treatment due to positive UAT results, as well as optimal strategies for UAT utilization. The purpose of this review is to summarize the UATs available for bacterial respiratory infections, describe current guidelines on their usage, and assess their impact on clinical outcomes and targeted therapy.

BACKGROUND: Whether the sensitivity of the BinaxNOW Streptococcus pneumoniae urinary antigen test kit (BinaxNOW), adjusted by some variables including vital signs, laboratory examinations and pneumonia severity, has been decreasing is unknown. The aim of the present study was to investigate whether BinaxNOW sensitivity has decreased recently and to identify the predictors of the BinaxNOW result, including the time trend.
METHODS: This prospective cohort study enrolled consecutive patients with pneumococcal community-acquired pneumonia who were hospitalised at Kurashiki Central Hospital from January 2001 to December 2015. Pneumococcal community-acquired pneumonia was defined as positive blood or pleural effusion or sputum culture results. To evaluate the effect of the time trend for the sensitivity of BinaxNOW, time series regression analysis was performed. In addition, predictors of the BinaxNOW result were examined by multivariable analysis using variables such as sex, vital signs, blood tests such as C-reactive protein, albumin, blood urea nitrogen, creatinine, white blood cell count, haematocrit and platelets, antibiotic pre-treatment, bacteraemia, and pneumonia severity, in addition to time trend and seasonality.
RESULTS: A total of 446 patients were included. BinaxNOW sensitivity showed a significant, gradual decrease from 2001 (81.3%) to 2015 (48.7%). On multivariable analysis [odds ratio (95% confidence interval)], bacteraemia [2.516 (1.387-4.561), P = 0.002] was a predictor of a positive BinaxNOW result, whereas male sex [0.467 (0.296-0.736), P = 0.001], white blood cell count [0.959 (0.930-0.989), P = 0.008] and the time trend per year [0.900 (0.859-0.943), P < 0.001] were predictors of a negative BinaxNOW result.
CONCLUSIONS: The sensitivity of BinaxNOW decreased over a 15-year period. We should be careful when interpreting BinaxNOW results in daily clinical practice, and the development of a new kit with good sensitivity is anticipated.
BACKGROUND: UMIN000004353.

OBJECTIVE: The aim of this study was to evaluate the diagnostic utility of a novel test kit that could theoretically detect all serogroups of Legionella pneumophila for diagnosing Legionella pneumonia, in comparison with existing kits.
METHODS: This study was conducted in 16 hospitals in Japan from April 2016 to December 2018. Three urinary antigen test kits were used: the novel kit (LAC-116), BinaxNOW Legionella (Binax), and Q-line Kyokutou Legionella (Q-line). In addition, sputum culture and nucleic acid detection tests and serum antibody tests were performed where possible. The diagnostic accuracy and correlations of the novel kit with the two existing kits were analyzed.
RESULTS: In total, 56 patients were diagnosed with Legionella pneumonia. The sensitivities of LAC-116, Binax, and Q-line were 79%, 84%, and 71%, respectively. The overall match rate between LAC-116 and Binax was 96.8% and between LAC-116 and Q-line was 96.4%. One patient had L. pneumophila serogroup 2, and only LAC-116 showed a positive result, whereas Binax and Q-line did not.
CONCLUSIONS: The novel Legionella urinary antigen test kit was useful for diagnosing Legionella pneumonia. In addition, it could detect Legionella pneumonia caused by non-L. pneumophila serogroup 1.

The urinary antigen test (UAT) is a rapid diagnostic method for pneumococcal pneumonia, but the high false-negative rate of 30% may affect its reliability. To maximize the utility of UAT, it is necessary to investigate the patient factors affecting UAT results. However, there is no report elucidating the association between its utility and pre-existing lung abnormalities. We retrospectively reviewed 388 patients with pneumococcal pneumonia confirmed by blood and/or sputum culture tests. Finally, 94 of 388 patients who had the results of UAT and computed tomography scans were enrolled to evaluate the association between the utility of UAT and patient factors including pulmonary emphysema and fibrosis. The overall positive rate of UAT was 69.1%. The positive rates of UAT in the patients with emphysema were significantly lower than those in individuals without emphysema (33.3% and 77.6%, p < 0.001). Univariate logistic regression analysis showed that the presence of emphysema was associated with a low positive rate (odds ratio 6.944, 95% confidence interval 2.268-21.231). Multivariate logistic analysis showed that the presence of emphysema and lower levels of serum blood urea nitrogen (BUN) were significantly and independently associated with a low positive rate. The combination of emphysema and BUN can potentially stratify the positive rate of UAT in patients with pneumococcal pneumonia. Patients with pneumococcal pneumonia and emphysema have a lower positive rate of UAT. Additionally, the combination of emphysema and serum BUN value may be useful to evaluate the reliability of the negative results of pneumococcal UAT.

Currently, diagnosis of legionellosis relies mainly on urinary antigen testing (UAT) for Legionella pneumophila serogroup 1 (Lp1). However, this test has several limitations, particularly missing non-Lp1 infections. The purpose of this large multicenter study was to investigate the risk of missing legionellosis relying on UAT solely. Molecular results of Legionella detection as part of a first-line (syndromic) testing algorithm for severe respiratory tract infections were investigated retrospectively and compared with UAT results in 14 Belgian laboratories. Overall, 44.4% (20/45) UAT results appeared false negative and were reclassified as legionellosis based on PCR findings [Legionnaires\' disease, 37.5% (15/40); Pontiac fever, 100% (5/5)]. A total of 39.4% (26/66) diagnosis probably would have been missed or delayed without a syndromic approach, as UAT or specific molecular testing for Legionella was not requested by the clinician. Furthermore, we confirmed the higher sensitivity of molecular Legionella detection in lower respiratory tract compared with upper respiratory tract specimens (p = 0.010).

We compared the clinical performance of the ImmuView L. pneumophila and L. longbeachae urinary antigen test (SSI Diagnostica A/S, Hillerød, Denmark) to that of the BinaxNOW Legionella urinary antigen card (Binax; Abbott, Lake Buff, IL) using urine specimens from patients suspected of having pneumonia. In total, 100 frozen urine samples (derived from 50 Legionella cases and 50 noncases) were analyzed with both tests, as were 200 nonfrozen prospectively collected samples. For urine samples from five Legionella cases and two non-Legionella cases, analytical sensitivity (limit of detection) and repeatability were examined. The urine samples from the five Legionella cases were diluted with urine samples that tested Legionella urinary antigen negative with both tests. The analyses of the 100 frozen samples resulted in a sensitivity and specificity of both ImmuView and the BinaxNOW of 96.0% (48/50) and 100% (50/50), respectively. Of the 200 nonfrozen samples, there were three samples that showed a positive result for L. pneumophila by both tests. The analyses of reproducibility showed that for the 34 (diluted) samples that were tested at two consecutive times, 33 samples showed a consistent result for both the ImmuView and the BinaxNOW tests (Cohen\'s kappa values of 0.916 and 0.928). In addition, the ImmuView test may have detected two L. longbeachae-positive urine samples, although other diagnostic tests could not confirm this. Both ImmuView and BinaxNOW showed high sensitivity and specificity for the detection of L. pneumophila serogroup 1 antigen in urine samples from clinical patients with a suspected lower respiratory tract infection.

A nosocomial case of Legionella pneumophila pneumonia likely caused by a serogroup 3 strain was detected by a urinary antigen test in Spain in 2018. Although Legionella bacteria could not be isolated from respiratory samples, molecular methods implicated the sink faucet of the patient\'s room as the probable infection source.

Legionella pneumophila is the causative agent of more than 95% cases of severe Legionella pneumonia. Nosocomial pneumonias in different hospital wards is an important medical and pharmaceutical concern. This study aimed to detect Legionella with two methods: polymerase chain reaction (PCR) and detection of urine antigenic test (UAT) in patients suffering from nosocomial pneumonia admitted to pediatric intensive care unit (PICU) of children hospitals. This study was conducted in PICU wards of Rasool Akram and Bahrami children hospitals, Tehran, Iran during 2013-2014. In patients diagnosed with hospital-acquired pneumonia, intratracheal secretion samples for PCR and urine sample for UAT were taken. Simultaneously, PCR and urinary antigen test were conducted using commercial kits. The results of urinary antigen test and PCR were analyzed by SPSS v.19 for statistical comparison. In this study, 96 patients aging 2.77 years on average with two age peaks of less than 1 year and 7-8 year were enrolled. More than half of the patients were under 1 year old. The most common underlying diseases were seizure, Acute Lymphoblastic Lymphoma, Down syndrome and metabolic syndromes. The positivity rate of Legionella urinary antigen test was 16.7% and positivity rate of PCR test was 19.8%. There were no significant associations between the results obtained by both assays with age, gender or underlying diseases. In conclusion, PCR is a better detection method for Legionella infection than urinary antigen test, but the difference between the two methods was not significant.