Showing posts with label Rapid Kits. Show all posts
Showing posts with label Rapid Kits. Show all posts

Wednesday, October 3, 2012

Risk Reduction and HIV Testing Messages Sent Through Social Networking Media Can Be Effective

Sean Young, PhD, MS Department of Family Medicine UCLA

This is part of an internal email mailed to a Gay Youth group:


...The machine is part of a small ‘pilot’ research study being conducted by a UCLA researcher named Sean Young (at the UCLA Center for HIV Intervention, Prevention, and Treatment Services). Pilots are small projects that are designed to establish the feasibility of answering a specific research question. If the results are promising, then the investigator can apply for funding for a full scale study.
 
This particular study is designed to assess whether risk reduction and HIV testing messages sent through social networking media can be effective in motivating someone to obtain an HIV home test kit from a vending machine. So the study is looking at both social network ‘diffusion’ of risk reduction information as well as acceptability of use of vending machines to obtain test kits.


Wednesday, March 7, 2012

Return Your HIV Diagnosis Now

Reposted from reducetheburden.org
RTB: The OMSJ has made it easy for you to turn in your false HIV diagnosis. Please read their article on “Erasing HIV’s Scarlet Letter,” and download the “Differential Diagnosis” forms, linked at OMSJ.org and below.


Erasing HIV’s “SCARLET LETTER” [Link]

1. Your first letter reminds your doctor who you are.  It should contain short questions about a) the tests he used, b) how the diagnosis was made, and c) the kind of response you seek.
BY CERTIFIED MAIL
(RECIPIENT) David Jones MD 123 Main Street Anywhere, MASS 00001
Re: HIV diagnosis of patient Michael Smith, (DOB: 5/28/72) Dear Dr. Jones: As you will recall, I visited you on (DATE/DATES).
At that time, you told me that I was “HIV Positive” which, as you might expect, was devastating. Although I had no reason to question your diagnosis at the time, I am no longer confident that your diagnosis was accurate. In fact, I don’t recall that you or anyone else ever conducted a diagnosis.
Please tell me what test or tests you used to diagnose me as HIV-positive.
I respectfully request that you respond to this letter within 2 weeks, so that we can set up a meeting to discuss the test and your diagnosis.
Sincerely, Signed/Name/Address

If you are asked to come in for a visit, do so – and bring a recording device.  During your visit, turn it on and lay it in plain sight so that both sides will know that the conversation is being recorded.
In some states and countries, it is illegal to secretly record someone.  If the device is sitting in the open, it should not violate any laws.  If you’re not sure, turn it on and say clearly that you are recording your conversation “because what they will say is important and you don’t want to misunderstand anything they’ve said.”  If they refuse, leave the recorder on and re-state that they want the recording device off.  Then leave the clinic, go home and write another letter.
If the doctor happens to respond in writing and identifies the test used, you’ll probably find the test in this list.  If he doesn’t identify it, pick one test, and ask if he used that test.  Mail your certified letter.
Your follow-up letters should ask exactly how he conducted his diagnosis.  He should explain exactly how he ruled out each of the 100+ conditions that are known to “cross-react” to HIV tests – conditions that include flu, tetanus and hepatitis shots, pregnancy, colds, the flu, physical injuries, and so forth.  Your doctor should be able to list ALL OF THE KNOWN CROSS-REACTIONS and explain exactly how he ruled out each one.  If he fails to answer this simple test, it suggests that he did not conduct a competent diagnosis.
Just as a policeman must rule out gunshot wounds, stoke, diabetic shock or other ailments before arresting someone for drunk driving, your doctor must identify and all of the known conditions that cause false positive test results and explain exactly how he ruled them out.
Your objective is to pin down the doctor.  Don’t let him play “hide the penny” with you.
Once you’re satisfied that your first letter and follow-up questions have been answered, move to second letter.

Tuesday, February 7, 2012

HIV Tests Are Not HIV Tests. WHAT?

HIV tests do not detect HIV or HIV antibodies.  HIV tests detect antibodies.  Period.  Test manufacturers claim that their tests are 99 percent accurate for sensitivity and specificity.
SENSITIVITY measures how often a test is positive when you already know what you are testing for is present.  SPECIFICITY expresses how often a test is positive when a patient DOES NOT have the condition.
In all HIV test literature, sensitivity and specificity are not based on measurements of the test against an isolated virus, but is a concordant measure between two tests that do not detect HIV or HIV antibodies.  Careful examination of the manufacturer’s label information makes this clear contrary to their claims of sensitivity and specificity of 99.9 percent.  The vast majority of these reported measures of accuracy have nothing to do with whether HIV is present, but how well one test performs as compared to other tests already on the market.  These measures of accuracy refer to the concordance between two tests; namely, how often a new test says a sample is positive when one already on the market says it is positive (sensitivity), and how often it is negative (specificity).  Given the fact that all HIV antibody tests are based on the same molecular principles and built from the same portfolio of basic molecular building blocks, their remarkable concordance is not surprising.
However, even if two different tests demonstrate 100 percent concordance, that does not justify the use of either for purposes other than what they have been validated and approved for.  By analogy, if two different manufacturers were to construct two different timepieces using the same specifications for the gears and wheels, only to put them in different casings, it is very likely that these two clocks would perform quite similarly.  However, even if there were greater than 99.9 percent concordance between these two timepieces, one cannot conclude that either clock measures time accurately.
HIV tests are so notoriously inaccurate that ALL FDA-approved HIV test package inserts warn clinicians that persons who test positive can only be “PRESUMED to be infected.”

Tuesday, January 24, 2012

Tanzania: Rejected HIV Test Kits Doubted Since 2007


Tanzania Daily NewsREPORTS have emerged that a deal to import and supply HIV Test kits manufactured by South Korean firms that were later found to be defective was questionable since 2007.
Earlier this month, the Minister for Health and Social welfare, Dr Hadji Mponda, announced the withdrawal of a South Korean HIV test kit from circulation following warnings about its poor quality.
In November, the UN World Health Organization (WHO) removed the Standard Diagnostics Bioline® HIV 1/2 3.0 Rapid HIV Test Kit from its list of approved rapid test kits with immediate effect; the alert was issued after Bioline failed quality assurance tests.
"What we know so far is that 1,178 test kits have been used in the field, but we have yet to substantiate exactly how many of them were defective," Dr Mponda, was quoted as saying at a news conference on January 5.

Friday, January 6, 2012

Recall of Standard Diagnostics Bioline® HIV 1/2 3.0 Rapid HIV Test Kit


The World Health Organization (WHO) has issued a global alert to remove the Standard Diagnostics Bioline® HIV 1/2 3.0 Rapid HIV Test Kit from its list of approved rapid test kits with immediate effect. The global alert on the Bioline Rapid Test Kit was issued following failures in quality assurance tests.

Wednesday, January 4, 2012

False positive HIV tests: the problem no one wants to talk about (and how to solve it)

By PLoS Guest Blogger

Guest post by Leslie Shanks of MSF, the second of three guest posts from the 2011 ICASA conference in Addis Ababa. The International Conference on HIV/AIDS and Sexually Transmitted Infections in Africa (ICASA) is the principal forum on HIV/AIDS & STIs in Africa.
“Finally, someone is talking about this.” I heard this refrain frequently at the recent ICASA conference in Addis-Ababa, Ethiopia after telling people about the satellite session hosted by Doctors Without Borders/Médecins Sans Frontières (MSF). The difficult topic: false positive HIV tests.
In resource-limited settings, HIV diagnosis is done with rapid diagnosis tests (RDT) using two or three different RDTs in either a serial or parallel algorithm (according to national guidelines). Rapid tests allow scale up and decentralization of treatment, both of which are essential to saving lives. Yet RDTS are screening tests –they were not designed for definitive diagnosis [1]. They work well for screening blood transfusions and identifying people who need further tests, but are known to yield false positive results due to serological cross-reactivity (or to inadequate quality control and human error (e.g. mislabeling of specimens). I first came across this unpleasant reality in Bukavu, DRC while working as a medical coordinator for MSF in 2005. We were running the first program offering ART to the province and had tested nearly 6000 people. But late in 2004 we came to realize that some people in our program did not have HIV, so we re-tested a number of them—and identified almost 50 who were suspect for false positive HIV diagnosis. This news was devastating, considering the consequences a false diagnosis can have on people’s lives.

Saturday, November 19, 2011

Spontaneous HIV Seroreversion: Real or Apparent?

Reader Remarks on:

Denis, Siakama. Wanyama.

I have come across a patient also confirmed HIV positive from 2 different institutions using the rapid kits, determine and unigold. She had CD4 trend drop hence initiated on ART, and her immunity responded accordingly with a rise in CD4 count. Later, rapid tests done, were NEGATIVE, ELISA also confirmed NEGATIVE and viral load done, undetectable! This has left us in a very peculiar position.