LIFECELL INTERNATIONAL PVT LTD

MATERNAL BLOOD SCREENING REPORT

Name Of Client : B/O ANCHAL AWASTHI CRM No : 180004200044

Sample Collected On : 10-05-2018 12:03 Lab ID No : 278954
Sample Received On : 11-05-2018 22:50
Date Of Report : 29-06-2018 12:48
Initial Report Duplicate Report Revised Report Version No 1

TEST REPORT
PARAMETER RESULT SPECIFICATION

Maternal Blood Sample Stored Yes For Information

Anti-HBC Non Reactive Non Reactive

By ELISA

Anti-HCV Non Reactive Non Reactive

By ELISA

HIV I / II (Ab) Non Reactive Non Reactive

By ELISA

Anti-HTLV I & II Non Reactive Non Reactive

By ELISA

HBsAg Non Reactive Non Reactive

By ELISA

CMV IgG Reactive Non-Reactive/Reactive

By ELISA/CLIA

CMV IgM Non reactive Non Reactive

By ELISA/CLIA

SYPHILIS Non Reactive Non-Reactive

By ELISA/Flocculation

MALARIA Negative Negative

By ELISA/Microscopy(Thick & Thin Smear)

Blood Group & Rh Typing B Positive Blood Group(ABO) & Rh Factor

By Column Agglutination Technology/Hemagglutination

1
Disclaimer: If one or more Infectious disease tests are positive (except CMV IgG) or Test not performed, your baby's cord blood unit is suitable for Autologous
2
Transplantation only and may not be suitable for Allogenic Transplantation purposes.

1. Autologous: Self use.

2. Allogenic: Non-self use.

* Parameter Not under NABL Scope DR. CHIRAYU PADHIAR, M.B.B.S..: DCP (G25442)
This is electronically generated report.
Senior Medical Director
 Frequently Asked Questions - Maternal Blood

Transfusion Transmissible Infections (TTI):

A transfusion transmissible infection (TTI) is any infection that is transmissible from person to person through parenteral
administration of blood or blood products.
These viruses or bacteria may also be transmitted during organ transplantation, sexual contact, from mother to baby via
placenta (before delivery) or trans-vaginal (at time of delivery) or via breast milk (after delivery). A person can also get
infected by sharing of needles as is common in drug addicts. These viruses are not spread through ordinary day-to-day
contact such as kissing, hugging, shaking hands, or sharing personal objects, food or water. Apart from blood transmission,
some infections like malaria are spread by mosquito bites, specifically Anopheles mosquito.

Screening of cord blood units:

The strategy for umbilical cord blood donation adheres to a similar algorithm as whole blood donation except that the tests
are done on maternal blood. This approach is taken because it is assumed that infections disease present in the UCB would
have originated from the mother, and thus the best chance of detecting infectivity would be in a maternal blood sample.
LifeCell tests a sample of maternal blood for TTIs in order to identify cord blood units that might harbour harmful infectious
agents. This screening is critically important because cord blood units are administered intravenously into recipients without
any further treatment to inactivate infectious agents, who might be the same person (autologous) or different person
(allogenic).

Following infectious disease tests are performed at LifeCell:

 HIV (HIV I & II antibodies & HIV-I p24antigen)
 Hepatitis B (HBsAg & Anti HBc)
 Hepatitis C (Anti HCV)
 Syphilis
 Malaria
 Cytomegalovirus (CMV IgG & IgM)
 HTLV I & II

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.

Risk to your baby if you test positive for an Infectious Disease:

Vertical transmission of virus from mother to child (MTCT) is possible. Consult your child’s physician for testing and care of
the child’s health.

Status of cord blood stored:

Cord blood units collected from mothers who test positive for an infectious disease agent (except CMV-IgG) are considered
potentially infectious and quarantined. Such cord blood units can be released only for autologous transplantation. They
cannot be released for allogeneic transplantation i.e. for any other person except the child or mother; unless indicated by
‘Emergency Medical Needs’.

Disclaimer: This fact sheet is for information only and is not meant to be used for self-diagnosis or as a substitute for consultation with a
health care provider. Detailed factsheets can be found on our website. Pls. visit www.lifecell.in. For more information, kindly contact your
health care provider.
 Frequently Asked Questions - Maternal Blood

Transfusion Transmissible Infections (TTI):

A transfusion transmissible infection (TTI) is any infection that is transmissible from person to person through parenteral
administration of blood or blood products. These viruses or bacteria may also be transmitted during organ transplantation, sexual
contact, from mother to baby via placenta (before delivery) or trans-vaginal (at time of delivery) or via breast milk (after delivery).
Apart from blood transmission, some infections like malaria are spread by mosquito bites, specifically Anopheles mosquito.

Following infectious disease screening tests are performed at Life Cell:

HIV (HIV I & II antibodies & HIV-I p24antigen), Hepatitis B (HBsAg & Anti HBc), Hepatitis C (Anti HCV), Syphilis, Malaria,
Cytomegalovirus (CMV IgG & IgM), HTLV I & II, NAT

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/HCV-NAT technology. If confirmatory test results are positive 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:

Almost all false-positive test results 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:

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):

NAT is a highly sensitive test which detects a particular virus or bacteria even at very low viral/bacterial load for HCV and HIV. 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.

Risk to your baby if you test positive for an Infectious Disease:

Vertical transmission of virus from mother to child (MTCT) is possible. Consult your child’s physician for testing and care of the child’s
health.

Status of cord blood stored:

Cord blood units collected from mothers who test positive for an infectious disease agent (except CMV-IgG) are considered
potentially infectious and quarantined. Such cord blood units can be released only for autologous transplantation and they are not
released for allogeneic transplantation i.e. for any other person except the child or mother; unless indicated by ‘Emergency Medical
Needs’.

Disclaimer: This fact sheet is for information only and is not meant to be used for self-diagnosis or as a substitute for consultation
with a health care provider. Detailed factsheets can be found on our website. Pls. visit www.lifecell.in. For more information, kindly
contact your health care provider.