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Clinical Updates:
July 2, 2010
New Test Release
HCCL is pleased to announce the
availability of HPV-High Risk testing and HPV Genotyping beginning July 12, 2010.
(click .pdf for Newsletter)
NEW!! C.
Difficile by PCR is available beginning Monday, (May 24, 2010).pdf
(click on
.pdf for Newsletter)
(Click on CAP TODAY for article on C. Difficle)
NEW!! HSV 1 and HSV 2 by RT-PCR (effective June 7, 2010)
Human herpes simplex virus (HSV) types 1 and 2 are common and important
pathogens, which may cause severe disease in newborns and immunosuppressed
patients (1). In immunocompetent subjects, both primary and reactivated
infections are usually mild but rarely spread to the central nervous system
causing encephalitis, myelitis, and meningitis. HSV-1 typically causes orofacial
blisters, keratitis, pneumonia, or encephalitis and has emerged as a common
cause of genital herpes. HSV-2 typically causes genital lesions or meningitis
(which may be recurrent). Both types may cause severe disease when transmitted
perinatally.
Herpes viruses cycle between periods of active disease – presenting as blisters
containing infectious virus particles – that last 2-21 days, followed by a
remission period, during which the sores disappear. Genital herpes, however, is
often asymptomatic, though viral shedding may
still occur. After initial infection, the viruses move to sensory nerves, where
they reside as life-long, latent viruses. Causes of recurrence are uncertain,
though some potential triggers have been identified. Over time, episodes of
active disease reduce in frequency and severity (2).
Herpes simplex is most easily transmitted by direct contact with a lesion or
body fluid of an infected individual. Transmission may also occur through
skin-to-skin contact during periods of asymptomatic shedding. Barrier protection
methods are the most reliable method of preventing transmission of herpes, but
they merely reduce rather than eliminate risk. Early stages of orofacial herpes
and genital herpes are harder to diagnose; laboratory testing is usually
required. Twenty percent of the U.S. population has antibodies to HSV-2,
although not all of them have a history of genital lesions (2).
Specimen types:
Urogenital swabs, endocervical swabs, swabs from vesicles and/or other genital
lesions (vesicles should be punctured and the vesicle fluid collected with a
swab), all swabs are to be placed in M4 viral transport media or in V-C-M Medium
(minimum 0.3mL)-ship frozen
Urine collected in sterile container-ship refrigerated
Cerebrospinal fluid (CSF) is to be placed in a sterile leak proof container-ship
frozen
Other Acceptable Specimens:
Serum, plasma (EDTA, ACD, or PPT), whole blood (EDTA, ACD); pleural,
pericardial, amniotic or vitreous fluid in sterile leak-proof container. Minimum
2 mL volume for whole blood, plasma, and serum.
Shipping and Handling
Transport Temp.
Freeze CSF, M4 medium, serum, and plasma.
Refrigerate whole blood and urine samples.
Hepatitis C
RNA, Quantitative Real-Time PCR
HCCL is
pleased to announce the availability of Hepatitis C RNA, Quantitative
Real-Time PCR. The detectable limit and reportable range provides the
sensitivity needed to detect very low viral loads as well as quantitate
levels that are very high.
The
Hepatitis C Quantitative Real Time PCR assay is an in vitro reverse
transcription-polymerase chain reaction (RT-PCR) assay for the
quantitation of the Hepatitis C virus on the automated m2000 System in
human plasma from HCV infected individuals over the range of 12 to
10,000,000 IU/mL or 1.1-7.00 Log IU/mL. The HCV Real Time PCR assay is
intended for use in conjunction with clinical presentation and other
laboratory markers for disease prognosis and for use as an aid in
assessing viral response to antiretroviral treatment as measured changes
in plasma HCV RNA levels. This assay is not intended to be used as a
donor screening test for HCV or as a diagnostic test to confirm the
presence of HCV infection.
For specimen requirements pertaining to collection, shipping and
handling, please refer to the test menu option.
Influenza
A H1N1 (2009)
Test
HealthCare
Clinical Laboratories is pleased to announce the availability of the
Novel H1N1 Influenza Virus and the HIV 1 RNA Quantitation
Abbott RealTime PCR assay.
The test is a Real
Time RT-PCR assay for human influenza A virus, and the differential
detection of 2009 H1N1 influenza virus in nasopharyngeal swabs,
nasal swabs, throat swabs and nasal aspirates only. The sample is
to be placed in viral transport media. Stability is 48 hrs at RT, 7
days refrigerated and 30 days frozen.
The assay provides
two
test
results. One result is for the detection of the seasonal
influenza A virus and the other result is for the Novel 2009
H1N1 influenza virus in the specimen.
Testing is
currently performed Monday through Friday, with plans to increase
frequency soon.
Testing with the
2009 H1N1 kit should not be performed unless the patient meets
clinical and epidemiologic criteria for testing suspect specimens.
(May
24, 2010)
FDA Clears First 2009 H1N1
Influenza Virus Test Previously Available Under Emergency Use
Authorization.
Clearance will allow continue use of Simplexa Influenza A H1N1 (2009)
test
Abbott RealTime
HIV-1 Test
Based on several
published studies, current molecular or PCR based diagnostic tests
vary in their ability to detect and reliably quantify variant
strains of HIV-1 and have been found to under-quantify them. As
such HCCL is adopting the Abbott RealTime HIV-1 assay because of this assays demonstrated ability to detect and measure
diverse group M subtypes of HIV-1 including all known non-B
subtypes, as well as group M, N and O isolates.
Also, the Abbott
RealTime HIV-1 Assay and Abbott m2000 System have been
recommended as a standard protocol for viral load testing in
HIV/AIDS clinical trials sponsored by the National Institutes of
Health (NIH).
The recommendation applies to testing performed at adult and
pediatric therapeutic HIV/AIDS clinical trial sites both in the
United States and internationally, as well as the centralized
network laboratories in the United States.
The Abbott RealTime HIV-1 test is intended for use in
conjunction with clinical presentation and other laboratory markers
as an indicator of disease prognosis and for use as an aid in
assessing viral response to antiretroviral treatment as measured by
changes in plasma HIV-1 RNA levels. The assay is not intended to be
used as a donor-screening test for HIV-1 or as a diagnostic test to
confirm the presence of HIV-1 infection. The report will include both copies/mL and log copies/mL when
detected.
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