PLoS One. 2012; 7(4): e29656.
Published online 2012 Apr 20. doi: 10.1371/journal.pone.0029656
Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory... tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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Qualitative assay for use on the cobas®6800/8800 Systems. For in vitro diagnostic use
Leptospirosis is a zoonotic disease with epidemic potential, especially after a heavy rainfall,
caused by a bacterium called Leptospira. Leptospira interrogans is pathogenic to humans and
animals, with more than 200 serologic variants or serovars. Humans usually acquire
leptospirosis through dire...ct contact with the urine of infected animals or a urine-contaminated
environment. Human-to-human transmission occurs only very rarely. Leptospirosis may present
with a wide variety of clinical manifestations, from a mild illness that may progress to a serious
and sometimes fatal disease. Its symptoms may mimic many diseases, such as influenza,
dengue and other viral haemorrhagic diseases; making the correct diagnosis (clinical and
laboratory) at the onset of symptoms is important to prevent severe cases and save lives,
primarily in outbreak situations.
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Most neglected tropical diseases (NTDs) occur in remote areas of low- and middle-income countries, where health systems are often poorly developed. Therefore, these neglected patients generally lack access to quality preventive, diagnostic, and therapeutic care [1]. The difficulty to access NTD-ende...mic areas, challenging logistics, and the lack of skilled human resources in these areas are also major obstacles to conduct clinical research. We had to face these when conducting a good clinical practice/good clinical laboratory practice (GCP/GCLP)-compliant clinical study in eastern Sudan, a well-known endemic area for visceral leishmaniasis and other NTDs. We share here the challenges related to study preparation and implementation of this GCP/GCLP study that investigated the causes of persistent fever in a rural hospital located in Gedaref State in eastern Sudan. We think this type of paper may be of interest for researchers planning to conduct a clinical trial in a resource-limited setting as well as for funders of such research.
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Diagnosis, Case Management Prevention and Control of Leptospirosis
This WHO laboratory manual provides the most up to date methods and procedures for the laboratory identification of yellow fever virus infection in humans. It provides guidance on the establishment and maintenance of an effective laboratory providing routine surveillance testing for yellow fever, wh...ich operates within the WHO coordinated Global Yellow Fever Laboratory Network (GYFLaN) capable of providing confirmation of yellow fever infection reliably and timely. This second edition supersedes the first edition of the 2004 WHO manual for the monitoring of yellow fever virus infection.
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i. A person who is a contact of a probable or confirmed mpox case in the 21 days before the onset of signs or symptoms, and who presents with any of the following: acute onset of fever (>38.5°C), headache, myalgia (muscle pain/body aches), back pain, profound weakness or fatigue.
OR
ii. A per...son presenting since 01 January 2022 with an unexplained acute skin rash, mucosal lesions or lymphadenopathy (swollen lymph nodes). The skin rash may include single or multiple lesions in the ano-genital region or elsewhere on the body. Mucosal lesions may include single or multiple oral, conjunctival, urethral, penile, vaginal, or ano-rectal lesions. Ano-rectal lesions can also manifest as ano-rectal inflammation (proctitis), pain and/or bleeding.
AND
for which the following common causes of acute rash or skin lesions do not fully explain the clinical picture: varicella zoster, herpes zoster, measles, herpes simplex, bacterial skin infections, disseminated gonococcus infection, primary or secondary syphilis, chancroid, lymphogranuloma venereum, granuloma inguinale, molluscum contagiosum, allergic reaction (e.g., to plants); and any other locally relevant common causes of papular or vesicular rash.
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