It is a research study that investigate whether a device, or treatment is safe and effective for human. The clinical trial that I was involved in is about test device was developed to detect the HIV and syphilis at the same time. The product’s name is DPP® HIV Syphilis Assay System, which is an in vitro qualitative, single-use Dual Path Platform (DPP) lateral flow immunoassay for the simultaneous identification of HIV antibodies and Treponema pallidum in three samples type: venous whole blood, plasma, and finger stick whole blood.
The test was created by adding an additional T. pallidum antibody test line to the previous DPP HIV 1/2 Assay which has been approved by FDA in December 2012. By combining these two analytes into a new multiplex
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On-site monitoring carried out as-needed basis, as determined by review of the data forms supplied during the clinical study and review of the Nextrials PRISM Database.
Method:
To run the test, a whole blood (finger stick or venous whole blood) or plasma specimen (a sample loop of approximately 10 µL) is mixed with pre-measured buffer in a DPP® SampleTainer® Bottle for 10 seconds. Two drops of the sample-buffer mixture are placed into Sample+Buffer Well #1 of the test device. The sample migrates along a nitrocellulose-coated strip to the test and control areas of a second strip, where specific HIV and T. Pallidum antigens (test areas) and non-specific IgG capture proteins (control area) are immobilized. Five minutes later, the sample migration is complete and soluble colored dyes on the test and control lines are washed away, indicating successful sample addition. HIV and/or treponemal antibodies, if present in the sample, bind to the immobilized HIV and treponemal antigens on the test lines, and non-specific IgG in the sample binds to the control line.
After Five minutes of adding the sample, four drops of Running Buffer are added to Buffer Well #2. The buffer hydrates the dried antibody-binding colored conjugates, which migrate to the test and control areas and bind to any HIV and/or treponemal antibodies present, and also bind to the control antibodies, producing one or more colored lines. Result
A horseradish peroxidase (HRP) is then added to each of the microtiter well which leads to the formation of a sandwich. The sandwich is composed of a polyclonal antibody, monoclonal antibody and chromogranin A. The unbound monoclonal antibody is later on washed out in the subsequent washing step. Detection of this immunocomplex is achieved by incubating the well with a substrate solution in a timed reaction and then a spectrophotometric microplate reader is used to take the readings (Stivanello
For forty years between 1932 and 1972, the U.S. Public Health Service (PHS) conducted an experiment on about six hundred black men of whom four hundred were infected with syphilis, while the other two hundred uninfected served as the control group. to determine the natural course of untreated syphilis in black male in Macon County, Alabama. These men, for the most part illiterate sharecroppers were never told what disease they were suffering from or of its seriousness. The victims were lured to the hospital with promises of free transportation, lunches, medical care, and burials, they were informed that they were being treated for “bad blood,” and fact their doctors had no intention of curing them of syphilis at all. The study was meant to discover how syphilis affected blacks as opposed to whites, the theory being that whites experienced more neurological complications from syphilis whereas blacks were more susceptible to cardiovascular damage. The true nature of the experiment had to be kept from the subjects to ensure their cooperation. Almost none of these victims has ever seen a doctor before, and were pleased to hear that they were getting free medical treatment for “bad blood”.
After the macromolecular material has been introduced to the selected matrix within a controlled apparatus, essentially a shallow plastic box, electrical nodes attached to opposite ends of the apparatus supply the matrix with a positive and negative electrical current, respectively. Because of phosphate groups present in nucleic acids, DNA and RNA possess a natural negative charge and will be opposed by the applied negative current. The macromolecules will then begin to migrate away from the negative node and toward the positive node along a horizontal pathway. As the macromolecules migrate, their varying components will be caught and separated within the pores of the charged matrix. In this sense, the matrix acts as a sieve rendering the components discrete for analysis. Proteins, moreover, behave identically to nucleic acids during electrophoresis in terms of reactivity, but require treatment with sodium dodecyl sulfate prior to electrophoresis. This detergent binds with polypeptide chains within the protein and imparts it an overall negative charge. The protein is then opposed by the negative charge and migrates toward the positive charge within the apparatus. Multiple samples may be tested simultaneously within the electrophoresis apparatus because each box contains small buffer lanes or "wells" that separate the samples within the matrix. This allows for
Monitor and document cardiovascular status: heart rate and rhythm, heart sounds, blood pressure, pulse pressure and the presence or absence of peripheral pulses. Compare to the baseline assessment. Report abnormalities to the physician, particularly tachycardia, a new S3 heart sound or systolic murmur, hypotension, decreased pulse pressure or pulse loss or increased arrhythmias
The Clinical Research Monitors will review up to 10% of the study participants annually for appropriateness of the informed consent process, eligibility, SAE reporting (TRACKS), and patient protocol status. Additional information may be monitored at the request of the Internal Monitoring Committee (IMC), the IRB, or other institutional administration. The Monitor will generate a formal report which is shared with the Principal Investigator (PI), study team and the IMC.
Patient T.R. presents for a routine physical exam and bloodwork. Patient reports a healthy diet, exercises three-four times per week, takes a multivitamin daily, and omeprazole occasionally for heartburn relief. His husband is HIV positive, but T.R. is not and has never received antiretroviral therapy. T.R.’s labs are normal with the exception of CD4+ T-cell count: 210 cells/mm3; Viral load: 10,000 copies/ml; Genotype: No resistance mutations detected. He is diagnosed with asymptomatic HIV infection. Treatment goals for T.R. include decreasing plasma HIV RNA, maintaining immune system function, preventing opportunistic infections, and preventing transmission of HIV ("AIDSinfo | Information on HIV/AIDS Treatment, Prevention and Research," n.d.).
First rapid HIV diagnostic test kit gets approve for use in the U.S. Test provides 99.6% accuracy in a little over 20 minutes.
Guidelines are important in all fields, but especially so in the field of biomedical science and engineering. There is a great deal of pressure on scientists to solve the ailments that plague our society, and one of the methods to accomplish this is immunotherapy. Immunotherapy can have a huge impact on how we treat diseases such as cancer or even just basic bacterial infections. The study of antibodies can also assist those who are immunocompromised, such as HIV/AIDS patients, or those who have other immunodeficiencies, such as autoimmune disorders or those who have recently undergone organ transplants. With so much riding on the study of these small but important proteins, it is so important to have the right materials and knowledge of how to use such materials for accurate results.
In order to undergo certain diagnostic test a patient must sign a document indicating that he/she voluntarily gives permission for the test to be carried out. The patient is informed of the nature and all aspects of the test by his/ hers health care provider or the appropriate lab personnel, so he/she can make a decision whether or not to be subjected to the test. The procedure should be explained in a comprehensive manner, using terms that the patient would understands. Areas covered in the discussion should include but are not limited to:
Since the Human Immunodeficiency Virus (HIV) was discovered in 1983 by Francoise Barrè-Sinoussi and colleagues (reviewed by Weiss, 2013) an estimated 70 million people have been infected with this retrovirus (WHO, 2013). Of these, close to half have died of the clinical manifestation of the infection called AIDS (Acquired Immune Deficiency Syndrome). Although tremendous progress has been made, including accurate testing of patients and donated blood, development of effective anti-retroviral therapy (ART) drugs, and viral load testing to track patient progress, the antigenic diversity of the viral coat has stymied the development of an effective vaccine (reviewed by Weiss, 2013).
assess and screen the studies set by seeing if the meet the comprisal standard or if they need additional analysis;
Presented on pages 1 through 3 is a mock guide that will be handed out to public health professionals for the purpose of identifying and treating those afflicted with HIV.
The last part of this procedure, antibodies will be used to detect one specific protein from others on the membrane. Incubate the membrane with 10 ml of primary antibody for 10-20 minutes and then place on a rocking platform. Rinse the membrane quickly after with wash buffer on a rocking platform. After three minutes is up, discard the wash and incubate the membrane with 10 ml of secondary antibody for 5-15 minutes on the platform. Rinse the membrane again shortly after and wash the membrane for three minutes. Next, discard the wash and add 10 mL of HRP color detection reagent. Incubation will occur after this for 10-30 minutes. Once it is done, rinse the membrane twice with distilled water and blot dry.
will not give accurate results of infection of HIV until between 2 weeks and 3
Usually the national screening program begins with evaluating available national data so that a suitable sample representing the population which is intended to be tested should be identified. Once the sample has been identified, the targeted audience is then, invited to take part in the national screening program in which the purpose of this national testing is shared with them. The participants are usually encouraged to take simple tests by using test kits in the privacy of their own homes and then share the test kits with the specified health authorities.