Reliability of a Newly-Developed Immunochromatography Diagnostic Kit for Pandemic Influenza A/H1N1pdm Virus: Implications for Drug Administration

Abstract

BackgroundFor the diagnosis of seasonal influenza, clinicians rely on point-of-care testing (POCT) using commercially available kits developed against seasonal influenza viruses. However, POCT has not yet been established for the diagnosis of pandemic influenza A virus (H1N1pdm) infection due to the low sensitivity of the existing kits for H1N1pdm.Methodology/Principal FindingsAn immunochromatography (IC) test kit was developed based on a monoclonal antibody against H1N1pdm, which does not cross-react with seasonal influenza A or B viruses. The efficacy of this kit (PDM-IC kit) for the diagnosis of H1N1pdm infection was compared with that of an existing kit for the detection of seasonal influenza viruses (SEA-IC kit). Nasal swabs (n = 542) were obtained from patients with flu-like syndrome at 13 clinics in Osaka, Japan during the winter of 2010/2011. Among the 542 samples, randomly selected 332 were further evaluated for viral presence by reverse transcriptase polymerase chain reaction (RT-PCR). The PDM-IC kit versus the SEA-IC kit showed higher sensitivity to and specificity for H1N1pdm, despite several inconsistencies between the two kits or between the kits and RT-PCR. Consequently, greater numbers of false-negative and false-positive cases were documented when the SEA-IC kit was employed. Significant correlation coefficients for sensitivity, specificity, and negative prediction values between the two kits were observed at individual clinics, indicating that the results could be affected by clinic-related techniques for sampling and kit handling. Importantly, many patients (especially influenza-negative cases) were prescribed anti-influenza drugs that were incongruous with their condition, largely due to physician preference for patient responses to questionnaires and patient symptomology, as opposed to actual viral presence.Conclusions/SignificanceConcomitant use of SEA-IC and PDM-IC kits increased the likelihood of correct influenza diagnosis. Increasing the credibility of POCT is anticipated to decrease the inappropriate dispensing of anti-influenza drugs, thereby minimizing the emergence of drug-resistant H1N1pdm strains.

Rapid Immunochromatographic Detection of Serum Anti-α-Galactosidase A Antibodies in Fabry Patients after Enzyme Replacement Therapy

“…IC has been used for helping various clinical diagnoses at bedside, i . e ., detection of viruses [ 14 – 16 ]. In this study, we developed an IC-based assay method for detecting anti-GLA antibodies in serum.…”

Usefulness of hemoglobin examination in gingival crevicular fluid during supportive periodontal therapy to diagnose the pre-symptomatic state in periodontal disease

“…Hb amount in GCF was measured using an Hb detection kit (Check-Line Hemo®, Wakamoto, Tokyo, Japan) using immunochromatography (IC) with a human Hb monoclonal antibody [ 27 , 28 ]. A 10-μL sample of PBS extraction was added to 40 mL of IC solvent containing bovine serum albumin, polysorbate 20 (Tween 20, Sigma-Aldrich, St. Louis, MO, USA), and sodium acid in neutral PBS, and then, Hb in 50 μL of the solution was developed at 23 °C for 15 min with IC paper.…”

Correlation Between Gingival Crevicular Fluid Hemoglobin Content and Periodontal Clinical Parameters

“…Amount of Hb in GCF was measured with an Hb‐detection kit §§ using immunochromatography (IC) 17 , 18 with a human Hb‐monoclonal antibody. A 10‐μL sample of the PBS extraction was added to 40 μL of IC solvent containing bovine serum albumin, polysorbate 20, ‖‖ and sodium acid in neutral PBS, and then Hb in 50 μL of the solution was developed at 23°C for 15 minutes with immunochromatogram papers.…”