| DB ID | MyCo_1616 |
| Title | Variables affecting the performance of galactomannan assay in high-risk patients at a tertiary care centre in India |
| Year | 2013 |
| PMID | 23508427 |
| Fungal Diseases involved | Invasive aspergillosis |
| Associated Medical Condition | None |
| Genus | Aspergillus |
| Species | fumigatus |
| Organism | Aspergillus fumigatus |
| Ethical Statement | The study was approved as per protocol by the Institutional Review Board of the institution i.e. Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi, India. |
| Site of Infection | None |
| Opportunistic invasive | Opportunistic |
| Sample type | Body fluid |
| Sample source | Serum |
| Host Group | Human |
| Host Common name | Human |
| Host Scientific name | Homo sapiens |
| Biomarker Name | GM |
| Biomarker Full Name | Glactomannan |
| Biomarker Type | Diagnostic |
| Biomolecule | Protein |
| Geographical Location | India |
| Cohort | This single-centre prospective study was conducted in samples, from adult and pediatric patients, obtained from 2006 to 2009 in the Department of Clinical Microbiology at Sir Gangaram hospital, a tertiary health care center with an active transplant program in New Delhi, India. The study was approved as per protocol by the Institutional Review Board of the institution. A total of 81 patients of either sex with suspected IA were tested for the presence of GM antigen by one-stage sandwich immuno-enzymatic technique. The patients were sub-categorized into “proven,” “probable,” and “possible,” cases based on host factors, microbiological and clinical criteria, as per Invasive Fungal Infections Co-operative Group (IFICG) of the European Organization for Research and Treatment of Cancer and Mycoses study group case defi nitions (EORTC/MSG). Details of patients including clinical illness, underlying risk factors, radiological and histopathology fi ndings, laboratory investigations, treatment history and outcome were recorded. A total of 25 serum samples from healthy blood donors were also tested for the presence of galactomannan as controls. Eligible patients displayed at least one of the following host factors: Malignancy on chemotherapy within the last 3 months; neutropenia (<500 cells/ml); HSCT; solid organ transplant recipients, particularly those with fulminant hepatic failure or requiring hemodialysis, chronic steroid use (³4 mg methylprednisolone a day for at least a week in past 3 weeks, or during ICU stay for at least 5 days, or a cumulative dose of ³250 mg of methylprednisolone in past 3 months); immunocompromised patients of any etiology presenting with persistent fever despite fi rst line antibiotic therapy or with suspected pulmonary infection based on clinical signs and symptoms, or new chest X-ray abnormalities; and those suffering from HIV infection. Informed consent for diagnostic testing was taken from the patients at the time of admission to hospital. |
| Cohort No. | 81 |
| Age Group | None |
| P Value | None |
| Sensitivity | 0.917 |
| Specificity | 1 |
| Positive Predictive Value | 1 |
| MIC | None |
| Fold Change | None |
| Pathway | None |
| Disease Introduction Mechanism | Over the last two decades, invasive Aspergillosis (IA) has emerged as a major life threatening infection in immunocompromised patients, occurring in 8-15% of patients undergoing allogenic haemopoietic stem cell (HSCT) and solid-organ transplantation, and 33-43% patients with malignancy. Despite advances in therapy, mortality may occur in up to three-fourth of transplant recipients. Early diagnosis and appropriate antifungal therapy is important in reducing mortality and morbidity due to IA. However, conventional microbiological and serological techniques are often insuffi cient to ensure early diagnosis and monitoring invasive infections. In addition, clinical and radiological signs are usually insensitive or nonspecifi c. Though a diagnosis of IA by tissue biopsy remains the gold standard, it is invasive and may be potentially harmful, especially among patients with coagulopathy and thrombocytopenia. |
| Technique | ELISA |
| Analysis Method | ELISA Based |
| ELISA kits | Platelia Aspergillus EIA kit (Bio-Rad, France) (GM-ELISA) |
| Assay Data | None |
| Validation Techniques used | ELISA |
| Up Regulation Down Regulation | Increase |
| Sequence Data | None |
| External Link | None |
