One method for the detection of HCV is the VITROS 5600 integrated system by Ortho Clinical Diagnostics (Raritan, NJ). This summary will examine the instruments application, methodology and performance characteristics in general for the instrument and as it relates to HCV testing. The VITROS 5600 integrated system is produced by Ortho Clinical Diagnostics. Ortho Clinical Diagnostics is a part of the Johnson and Johnson Family of companies. The company has roots that date back to 1937 with the establishment of the Ortho Product division by Johnson and Johnson. In 1989 Ortho Clinical introduced the first assay for the detection of antibodies to hepatits C virus. In 2001 they became the first company to receive U.S. Food and Drug Administration approval for automated random access hepatitis test, performed on the VITROS ECi Immunodiagnostic system.
The Vitros 5600 is an integrated system that integrates immunoassay testing and clinical chemistry testing all in one platform. This high-capacity system is the first of its kind. The instrument was cleared by the FDA in October 2008 and there is currently greater than 900 units in clinical use worldwide.
The first thing to be reviewed will be application characteristics of the VITROS 5600. The instrument is 2.79m /109.7inches wide, 0.85m/33.5 inches in depth, 1.64m/64.5 inches in height, and weighs 1062kg/2340 pounds. The power requirements for voltage are two dedicated 20 amp power lines or one dedicated 30 amp power line with UPS, nominal 200-240V AC and the requirements for frequency is 47-63Hz. Environmental requirements include operating temperature 15°-30°C, ambient relative humidity 15%-75% RH, and altitude of up to 8,000 feet. The instrument does not require a water source or a drain. It is designed with a self-contained onboard waste management system in order to eliminate requirements for off board plumbing. The instrument generates 60 decibels of noise at idle and 65 while operational. The operator interface is a color coded graphical interface that uses an ergonomic flat low-glare 17inch touchscreen LCD. There is a numeric keypad that is also included on the monitor. In order to provide maximum flexibility the included keyboard is detachable. The time it takes for a single result will vary depending on the principal of the assay being performed. The range is as short as about 2.5 minutes for potentiometric assays and as long as about 16 to 73 minutes for microwell assays. In the case of the anti-HCV assay the estimated time for results is less than 60 minutes. The typical delay from ordering a stat test to aspiration of the sample is about 10 seconds. Sample types include serum, plasma, urine, CSF, whole blood, and amniotic fluid (not available in US). The type of sample will be dependent on the assay being performed. The anti-HCV assay is approved for serum and plasma samples. Sample volumes range from 2-180 µL. Samples can be continuously be loaded and unloaded as instrument is in operation and can hold 80 samples in universal sample trays and 10 samples in dedicated STAT lane. Stay tuned for more to come on the VITROS 5600.
Wow, this is an awesome method for detecting the Hepatitis C Virus, and I hope I actually get to at least see it in action one day. However, as I was reading, I noticed toward the end that even though amniotic fluid is an accepted specimen for the VITROS 5600, it is not used in the USA. This struck my curiosity. If this method has a way of testing amniotic fluid, why has our country decided not to use this as a way to detect HCV? One reason is because there are not any successful interventions known to prevent perinatal transmission of this virus. Research also showed that screening in asymptomatic pregnant women is not cost-effective as well as the overall seroprevalance of HCV is low(1.2%) among women of childbearing age. Another reason this would not be beneficial is there is only a 4-7% risk of vertical transmission in HCV-positive women. Therefore, the Centers for Disease Control and Prevention does not recommend routine screening of the HCV infection in pregnant women. Taking all of this into consideration, it is now clear why amniotic fluid is not a specimen of choice for the VITROS 5600.
ReplyDeletei am familier with VITROS it is so great because at my work we use VITROS 5,1 it does almost all chemistry in such a tiny amount os serum/plasma accept we do not do HCV testing!!!i really like it and very easy to use!!!
ReplyDeleteI hope to be able to use this instrument one day in the lab. It seems it be the better of the choices for screening for many infections and diseases and would help rule out misidentication.
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