Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Name Of Client :
CRM No : 160010800196
14-07-2016 13:00
Date Of Report :
27-07-2016 15:53
Initial Report
Lab ID No : 197262
Duplicate Report
Revised Report
Version No
TEST REPORT
PARAMETER
RESULT
SPECIFICATION
Yes
For Information
Anti-HBC
Non Reactive
Non Reactive
Non Reactive
Non Reactive
Non Reactive
Non Reactive
Non Reactive
Non Reactive
Non Reactive
Non Reactive
Reactive
Non-Reactive/Reactive
Non Reactive
Non Reactive
Non Reactive
Non-Reactive
Non Reactive
Non Reactive
B Positive
By ELISA
Anti-HCV
By ELISA
HIV I / II (Ab)
By ELISA
Anti-HTLV I & II
By ELISA
HBsAg
By ELISA
CMV IgG
By ELISA
CMV IgM
By ELISA
SYPHILIS
By ELISA
MALARIA
By ELISA
Disclaimer:
If one or more Infectious disease tests are positive (except CMV IgG), your baby's cord blood unit is suitable for Autologous 1 Transplantation only and
may not be suitable for Allogenic
Transplantation purposes.
Test methodology:
Initial screening tests involve detection of antigen and/or antibody to a particular virus or bacteria using ELISA/ECLIA
technology. If the screening tests are non- reactive, the test result is considered negative and cord blood unit is considered
safe for transplantation. If initial screening test is positive (except CMV-IgG) the test is repeated in duplicate with a different
kit/ platform. If both repeat results are non-reactive, the final interpretation is non-reactive or negative. If one or both
repeat tests are reactive, further confirmatory testing is performed. For HIV confirmation is done using Western Blotting. For
HCV, confirmation is performed by HCV-RIBA technology. If confirmatory test results are positive, the sample is interpreted
as repeatedly reactive and the corresponding blood unit is not permitted for allogeneic transfusion. All infectious disease
testing are undertaken in accordance with current regulatory and accreditation guidelines.
Screening assays are not 100% accurate. Sometimes test results can be falsely positive or negative. These are not necessarily
testing errors but occur due to inherent limitations in the particular test methodology. Repeat testing at a later date is
recommended.
False Positive Results:
This means that test results have come positive even when the individual does not harbour a particular virus or bacteria. This
is because, ID screening tests have cut off points chosen to make the test highly sensitive (to detect all infected individuals
and to reduce false negative results). However, to achieve this sensitivity, the assays also react with samples from some
individuals who are not infected (false positive results). To determine whether a repeatedly reactive result represents a true
infection rather than a false positive result, more specific testing may be performed on the donor sample at a later date.
Almost all false-positive test results occur because of interference with the test. This can also occur due to cross reactions
with other viral or bacterial particles; or in association with medical conditions such as pregnancy, recent acute illnesses and
allergies.
False negative results:
This means that test results have come negative even when the individual is infected with a particular virus or bacteria. False
negative results may be due to antibody levels below the limit of detection of the assay (window period) or lack of antibody
reactivity to the antigens used in this assay.
NAT (Nucleic acid amplification test):
Viruses and bacteria have a window period of testing. This is a time period between the first exposure to the virus and the
time it becomes detectable in blood by available diagnostic/screening tests. Various test methods have differing window
periods. This is because these test methods can detect the virus only after a certain viral load is attained in the body.
For example, fourth generation ELISA kits for HIV testing have a window period of roughly 11 days during which virus
particles are multiplying within the body but still cannot be detected by traditional ELISA/ ECLIA tests.
NAT is a highly sensitive test which detects a particular virus or bacteria even at very low viral/bacterial load. This allows us to
detect virus/bacteria where traditional ELISA/ECLIA would have failed; thus significantly reduces the risk of transmission of
virus in the window period. This test uses amplifies nucleic acid over 1000 folds using an amplification process. . Lifecell uses
Transcription mediated Amplification (TMA) for NAT Testing for HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C
Virus). NAT is done on all samples for detection of HIV & HCV. This is in addition to ELISA screening assays (many cord blood
banks in India do not use this double layer of testing).
While NAT testing significantly reduces window period, it cannot eliminate this window period completely. As against 11 days
of window period by traditional 4th generation ELISA kits for HIV, window period for NAT is as low as 3 days. False negative
results can come even with NAT testing (if patient has come in the window period of 3 days).
General precautions you need to take in case of positive test result if you test positive for a virus or bacteria:
DO see a doctor for medical evaluation, even if you do not feel sick.
DO consult a doctor about the transmission of infection to your baby through breast milk, as not all infections are
transfered through placenta.
DO use condoms when you have sex and inform your sexual partner.
DO tell anyone with whom you have had sex or shared needles or syringes that you are (and they may be) infected.
DO maximize your chances of remaining in good health by eating a healthful diet, exercising regularly, avoiding stress
and getting adequate rest.
DO NOT DONATE BLOOD, PLASMA, BONE MARROW, ORGANS, SEMEN/SPERM OR BREAST MILK FOR OTHERS.
DO NOT share needles or syringes with anyone.