Morbidity in live liver donors: standards-based adverse event reporting further refined.

HYPOTHESIS: The true extent of morbidity among live liver donors remains poorly understood. In this unique and often high-profile area of surgery, the development of standards for defining and reporting complications would foster a better understanding of the incidence and magnitude of such adverse events (AEs). DESIGN: Retrospective review of AEs among live liver donors. SETTING: University-affiliated teaching hospital. PATIENTS AND METHODS: Of 202 individuals undergoing evaluation for live liver donation, 42 (20.8%) proceeded to surgery. Thirty-four underwent a right lobectomy without the middle hepatic vein; 3, a left lateral segmentectomy. Any event causing a deviation from a patient's ideal course was considered an AE and subsequently classified according to a derived framework. Morbidity was defined as 1 or more AEs. MAIN OUTCOME MEASURES: Incidence, timing, type, severity, and impact of AEs. RESULTS: No deaths or significant hepatic dysfunction occurred. In 5 (12%) of the 42 donors, the hepatectomy was aborted for anatomic reasons before parenchymal transection. Eight (22%) of the remaining 37 experienced 11 AEs, of which 10 completely resolved, whereas 1 AE (3%) resulted in a permanent disability (brachial plexopathy). The overall incidence of AEs was 0.30 per case. Ten (91%) of the 11 AEs presented within the first postoperative month. CONCLUSIONS: Most live liver donations are uncomplicated or do not lead to permanent consequence. The adoption of a standards-based classification framework for AEs in live liver donors would allow for an inclusive, consistent, and universally applicable method to collect, analyze, and report donor morbidity.

Sensitivity of a rapid point of care assay for early HIV antibody detection is enhanced by its ability to detect HIV gp41 IgM antibodies.

BACKGROUND: Anti-HIV-1 IgM antibody is an important immunoassay target for early HIV antibody detection. OBJECTIVES: The objective of this study is to determine if the early HIV antibody sensitivity of the 60s INSTI test is due to detection of anti-HIV-1 IgM in addition to IgG. STUDY DESIGN: To demonstrate HIV gp41 IgM antibody capture by the INSTI HIV-1 gp41 recombinant antigen, an HIV-IgM ELISA was conducted with commercial HIV-1 seroconversion samples. To demonstrate that the INSTI dye-labelled Protein A-based colour developer (CD) has affinity to human IgM, commercial preparations of purified human immunoglobulins (IgM, IgD, IgA, IgE, and IgG) were blotted onto nitrocellulose (NC) and probed with the CD to observe spot development. To determine that INSTI is able to detect anti-HIV-1 IgM antibody, early seroconversion samples, were tested for reduced INSTI test spot intensity following IgM removal. RESULTS: The gp41-based HIV-IgM ELISA results for 6 early seroconversion samples that were INSTI positive determined that the assay signal was due to anti-HIV-1 IgM antibody capture by the immobilised gp41 antigen. The dye-labelled Protein-A used in the INSTI CD produced distinct spots for purified IgM, IgA, and IgG blotted on the NC membrane. Following IgM removal from 21HIV-1 positive seroconversion samples with known or undetermined anti-HIV-1 IgM levels that were western blot negative or indeterminate, all samples had significantly reduced INSTI test spot intensity. CONCLUSIONS: The INSTI HIV-1/HIV-2 Antibody Test is shown to detect anti-HIV-1 IgM antibodies in early HIV infection which enhances its utility in early HIV diagnosis.

Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care.

BACKGROUND: For broader utilization of rapid HIV antibody assays in point-of-care (POC) settings, methods should be simple enough to be performed with accuracy by untrained test providers, using only the test manufacturer's written instructions. OBJECTIVE: To demonstrate that the INSTI HIV-1 Antibody Test is simple and accurate enough to be successfully run by untrained operators in a POC setting. STUDY DESIGN: A prospective study was conducted to compare the results of the FDA-cleared, INSTI HIV-1 Antibody Test (INSTI, bioLytical Laboratories Inc., Richmond, BC, Canada) used by untrained operators on finger-stick whole blood to results obtained by trained laboratory professionals using FDA-cleared comparator methods (CM) on matching venous blood. A total of 1388 subjects were recruited into the study in three diverse US POC sites. One central laboratory was used for CM testing. Untrained operators and experienced laboratory professionals also conducted a study on prepared plasma specimens to compare limit of detection (LoD) abilities. RESULTS: Of the 517 HIV positive subjects (34 new positives and 483 known positives) the concordance between INSTI performed by untrained operators and CM performed by trained laboratory professionals was 100% (95% CI=99.3-100%). Concordance for HIV negative results (n=871) was 99.8% (95% CI=99.2-99.9%). There were no significant differences in INSTI limit of detection between untrained operators and laboratory professionals. CONCLUSIONS: Untrained operators with no laboratory background were able to perform and interpret the results of INSTI on finger-stick blood and LoD specimens with a high degree of accuracy by following only the manufacturer's written instructions.