Welcome to the Clinical Center Grand Rounds,
a weekly series of educational lectures for physicians and
health care professionals broadcast from the Clinical
Center at the National Institutes of Health in
Bethesda, MD.
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effort in training today's investigators and discovering
tomorrow's cures.
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TODAY WE'RE HONORED TO HAVE TWO
WHO WILL SPEAK TODAY ON COVID-19
CONVALESCENT PLASMA LESSONS
LEARNED.
OUR FIRST SPEAKER IS DR. KAMILLE
WEST MITCHELL.
DR. WEST MITCHELL EARNED HER
MEDICAL DEGREE FROM THE
UNIVERSITY OF WEST INDIES.
FOLLOWING HER RESIDENCY SHE
JOINED NIH AS A CLINICAL FELLOW
IN TRANSFUSION MEDICINE.
SHE BECAME A STAFF PHYSICIAN.
DR. WEST MITCHELL IS THE MEDICAL
DIRECTOR SERVING PEDIATRIC AND
ADULT PATIENTS TO SUPPORT
STEM-CELL TRANSPLANSTEM-- CELL TRANSPLANTA TION.
OUR SECOND SPEAKER IS
DR. VALERIA DE GIORGI.
SHE EARNED HER PhD IN CHEMICAL
SCIENCES FROM THE UNIVERSITY OF
NAPLES IN ITALY.
SHE OVERSEES THE TESTING LAB AND
LEADS IMPLEMENTATION VALIDATION
OF SATISFACTORY LOGICAL ASSAYS
FOR COVID-19 TESTING.
ADDITIONALLY DR. DE GIORGI IS
DEVELOPING A PROGRAM TO TEST
DONORS DONATED BLOOD COMPONENTS
USING NOVEL AND UNCONVENTIONAL
TECHNIQUES.
SHE IS A MEMBER OF THE SOUTHERN
SOCIETY O SEROLOGY.
AND HAS RECEIVED SEVERAL AWARDS.
DR. DE GIORGI'S TOPIC IS
SEROLOGICAL ASSAYS IN COVID-1 COVID-19
CONVALESCENT PLASMA DONORS.
PLEASE WELCOME DR. KAMILLE WEST
THANK YOU VERY MUCH AGAIN FOR
THE INVITATION TO PARTICIPATE.
I HAVE NO CONFLICT OF INTEREST
TO DISCLOSE.
I WILL BE DISCUSSING THE USE OF
UNLICENSED BLOOD PRODUCT --
TODAY WE WILL BE REVIEWING THE
EARLY DAYS OF THE COVID-19
PANDEMIC AND WHAT THE BLOOD BANK
POINT OF VIEW WAS DURING THAT
TIME.
AND THEN SUMMARIZING ELEMENTS OF
OUR EXPERIENCE AS WELL AS OTHER
LESSONS WE LEARNED ALONG THE
WAY.
A BRIEF INTRODUCTION -- YOU MAY
HAVE HEARD IN THE INTRODUCTION
THAT THE DEPARTMENT OF
TRANSFUSION MEDICINE COMPRISES
MULTIPLE SECTIONS.
OUR SECTION THE BLOOD SERVICES
SECTION IS CONCERNED WITH THE
HEALTHY BLOOD DONOR CENTERS FOR
COLLECTION OF BLOOD TO BE USED
AS WELL AS OVERSIGHT.
SO WE SOMETIMES SAY WE ARE THE
HUMAN SERVICES SECTION.
AND THE REMAINDER OF THE
SECTIONS ARE MOSTLY LABORATORY
BASED.
OUR BLOOD BANK IS A SMALL
HOSPITAL BASED BLOOD BANK.
WE COLLECT 4,000 UNITS A YEAR.
SO IN DECEMBER 2019 WHEN WE AND
THE WORLD BEGAN TO RECOGNIZE
THAT THERE WAS AN EMERGING
INFECTIOUS THREAT THAT MIGHT
AFFECT THE AVAILABILITY AND
SAFETY OF THE BLOOD SUPPLY --
BLOOD CENTERS STARTED
IMPLEMENTING DONOR EXCLUSIONS TO
TRY TO REDUCE SPREAD OF THIS
NOVEL CORONAVIRUS AS IT WAS
CALLED.
WE IMPLEMENTED SOCIAL DISTANCING
AND DISINFECTION OF SURFACEs
AND WE ASKED OURSELVES AS THE
COLLECTION ASPECT OF THE DETAIL
IS THERE ANYTHING ELSE THAT WE
CAN DO TO ADDRESS THE EMERGING
THREAT.
THE LABORATORY SECTIONS IN THE
DTM ARE OBVIOUSLY BUSY IN
VALIDATING CLINICAL ASSAYS AND
YOU'LL HEAR A LITTLE BIT ABOUT
THAT LATER BUT AS COLLECTIONS WE
THOUGHT WHAT WE COULD DO WOULD
BE TO COLLECT COVID CONVALESCENT
PLASMA?
THE PRINCIPLE OF COLLECTING
BLOOD FROM PERSONS WHO HAVE
RECOVERED FROM AN INFECTIOUS
DISEASE WHO MAY HAVE DEVELOPED
ANTI BODIES AND HAS BEEN USED
FOR OVER A HUNDRED YEARS.
IN THE SPANISH INFLUENZA
PANDEMIC -- IT WAS ALSO
ATTEMPTED -- AND OTHER SEVERE
CORONAVIRUS INFECTIOUSES.
SO IN EARLY 2020 WHEN THERE WERE
NO PREVENTIVE MODALITIES
AVAILABLE WE AND OTHERS
THROUGHOUT THE UNITED STATES
ANTICIPATED THERE MIGHT BE A
DEMAND FOR CONVALESCENT PLASMA
WE THOUGHT IT WAS SOMETHING THAT
WE COULD READILY MOBILIZE
INTERNALLY BECAUSE WE HAD THE
DEVICES THAT WERE USED TO
COLLECT THE PLASMA.
AND THE EXPERTISE.
THEY ARE AWARE OF HOW TO COLLECT
AND IN-HOUSE THE REGULATORY AND
QUALITY EXPERT ANALYSIS TO HELP
US NAVIGATE.
AND FURTHERMORE IN THE FIRST
THREE MONTHS -- APRIL, MAY, JUNE
IT WAS VERY DIFFICULT FOR
HOSPITALS TO OBTAIN CONVALESCENT
PLASMA BECAUSE THAT PROCESS WAS
STILL RAMPING UP.
THE EARLY PARTS -- IT WAS
ENCOURAGING -- SO WE ELECTED TO
WRITE A PROTOCOL BASED ON PLASMA
COLLECTION.
WE COLLECTED PLASMA FROM DONORS
WHO WERE SCREENED AND MET ARE
THE RELATIVE BLOOD DONOR
CRITERIA AS WELL AS THE
DOCUMENTED EVIDENCE.
WE ELECT TO PERFORM PLASMA --
BECAUSE WE COULD COLLECT THREE
TO FOUR TIMES AS MUCH.
AND ALSO WE DEVELOPED AN INITIAL
PLAN --
[ AUDIO DIFFICULTIES ]
FOR QUALIFYING THE PLASMA THAT
WE COLLECTED AND MORE ON THAT IN
FURTHER SLIDES.
NOTABLY THE CCP THAT WE
COLLECTED COULD BE USED UNDER
ONE OF TWO MECHANISMS.
THERE WERE CLINICAL TRIALS IN
INSTITUTIONS AND THE FDA GRANTED
EMERGENCY USE AUTHORIZATION.
WE INTERVIEWED AND EVALUATED THE
DONORS.
AND TO MITIGATE POTENTIALLY
FATAL COMPLICATIONS OF
TRANSFUSIONS.
WE SELECTED DONORS WHO WERE
NEGATIVE FOR ANTIBODIES.
AND FURTHER MORE WE HAVE TO
CONFIRM THAT THE DONORS DID IN
FACT HAVE EVIDENCE OF COVID
CONVALESCENT AS SPECIFIED BY THE
REGULATORY GUIDANCE AND THIS IS
WHERE IT BECAME COLORFUL.
THE SYMPTOMS CHANGED OVER TIME
AND BECAME MORE RESTRICTIVE.
AND THEN THERE WAS DISCUSSION OF
WHETHER LOSS OF SMELL AND TASTE
THAT MIGHT MAKE YOU INELIGIBLE
TO DONATE.
EVENTUALLY THE CRITERIA CHANGED
TO ONLY 14 DAYS OF CONVALESCENT
WITH NO NEED FOR A NEGATIVE
FOLLOW-UP TEST AND THEN TO 10
DAYS.
IT WAS TRICKY ESPECIALLY IN THE
BEGINNING.
DONORS WERE REQUIRED TO HAVE A
POSITIVE TEST AND THAT WAS
SPECIFIED THROUGH A MOLECULAR
TEST.
AS YOU RECALL THERE WERE A
NUMBER OF TESTS OVER 100 TESTS
FOR SARS-CO- INDIVIDUAL 2 THAT
FLOODED THE MARKET AND ONLY SOME
OF THEM WERE GRANTED EMERGENCY
USE AUTHORIZATION.
OR IF THERE WAS NO HISTORY OF
SYMPTOMS THE DONOR WOULD BE
QUALIFIED BY TWO SEPARATE TESTS.
AND IN JANUARY 2021 THE FDA
INCLUDED RESTRICTIONS OF
VACCINATION AND THOSE WHO HAD
RECEIVED MONOCLONAL THERAPY.
ADDITIONAL REGULATORY CHANGES
HAD AN IMPACT ON OUR WORKFLOW.
I WILL NOT SPEND A LOT OF TIME
TALKING ABOUT THE ACTUAL ASSAYS
BUT AS THE REQUIREMENTS CHANGED
THE THRESHOLDS WERE HIGHER THIS
HAD AN IMPACT ON OUR
COLLECTIONS.
IN APRIL 2020 THERE WERE NO
ASSAYS AVAILABLE AND THE
RECOMMENDATION AT THAT TIME WAS
FOR BLOOD COLLECTORS TO IDENTIFY
DONORS WHO MET THE CLINICAL
CRITERIA AND COLLECT PLASMA.
AND ONCE TESTING BECAME
AVAILABLE THEN TRY TO TEST AND
DETECT IF THERE WERE
NEUTRALIZING ANTIBODIES IN THE
PLASMA.
THE RECOMMENDATION WAS ALSO NOT
EASY TO COMPLY WITH BECAUSE
THERE WAS NOT TESTING WIDELY
AVAILABLE.
WE THANKFULLY FOUND A
COLLABORATOR -- WHO WAS ABLE TO
HELP US WITH THE FLUORESCENT
NEUTRALIZING ASSAY.
TO QUALIFY THE PLASMA WE HAD
COLLECTED.
IN AUGUST 2021 THE CCP WAS
GRANTED THRESHOLDS AND OVER TIME
REVISIONS OF THE EUA INCLUDED
REVISIONS THAT WERE ACCEPTABLE.
SO EACH TIME THERE WAS A
REGULATORY CHANGE IN WHAT WAS
QUALIFIED -- AND WHAT COULD BE
TRANS FUSED WE WOULD GO BACK AND
REVISE OUR PLAN OR STRATEGY FOR
COLLECTING DONORS AND LOOK AT
OUR IN-HOUSE REA IN -- HOUSE INVENTORY.
AND TOOK DETAILED NOTES.
AND THEN SIGNIFICANTLY IN
FEBRUARY 2021 THE EUA CRITERIA
NOW RESTRICT THE USE OF CCP.
AND MORE RECENTLY IN
DECEMBER 2021 THE RESTRICTION
REMAINS THE SAME BUT THE ASSAYS
USED TO QUALIFY THAT PLASMA HAVE
NOT CHANGED WHICH MEANS FOR ANY
FACILITIES WE STILL HAD IN-HOUSE
PLASMA COLLECTED.
WE WOULD THEN HAVE TO GO BACK
AND QUALIFY WHETHER OR NOT IT
WOULD MEET CURRENT CRITERIA.
OUR DONOR SELECTION PROCESS WAS
MORE RESPONSIVE THAN PROACTIVE
BECAUSE WE FOUND THAT ONCE WE
HOSTED OUR TRIAL CAN ACTUALLY
THE NIH BLOOD BANK WAS ALSO
LISTED -- TO ENCOURAGE PERSONS
TO DONATE CONVALESCENT PLACE
MAY.
-- PLASMA.
THE DONORS FOUND US.
WE DEVELOPED AND DEVISED
ALGORITHMS.
WE REALLY WERE MOVED AND STRUCK
BY THE MOTIVATED DONOR
COMMUNITY.
PEOPLE WANTED TO PARTICIPATE AND
WE ALSO GOT REFERRALS FROM
OUTSIDE HOSPITALS THAT DID NOT
HAVE ON-SITE DONOR CENTERS SO
THEY WERE NOT ABLE TO COLLECT
THEIR OWN CCP AND THOSE THAT
WERE NOT ABLE TO OBTAIN CCP FROM
MAJOR BLOOD COLLECTORS SO WE GOT
REFERRED DONORS AND THEN SHARED
SOME OF THE PLASMA WITH THE
OUTSIDE HOSPITALS.
SO OUR PRESCREENING PROCESS IN
THE EARLY DARK DAYS OF THE
PANDEMIC THERE WERE CHANGES TO
OUR OWN STRUCTURE.
SOME OF THE STAFF WERE
TELEWORKING.
SO COORDINATING FEASIBLE
WORKFLOWS TOOK SOME SNIFFING OUT
AND WE SETTLED ON SPECIFIC RULES
AND RESPONSES TO DONORS THAT
WORKED WELL FOR US.
WE ALSO HAD TO TAKE INTO ACCOUNT
ACCESS RESTRICTIONS.
SINCE OUR BLOOD BANK IS LOCATED
ON THE CLINICAL CENTER.
WE STARTED COLLECTING PLASMA IN
THE BEGINNING WITHOUT THE
EVALUATION SAMPLES.
WE HAD TO REVISE OUR OPERATIONAL
PROCESSES WITH THE OPERATIONAL
CHANGES AND REGULATORY CHANGES.
JUST TO GIVE YOU AN IDEA WE HAD
TO EXCLUDE MOST OF THE DONORS
PARTICULARLY IN THE APRIL TO MAY 2020 PERI OD WHO CONTACTED
US.
MOST OF THE CANDIDATE DONORS
CONTACTED US.
THEY FELT ILL AND WERE NOT ABLE
TO GET A TEST.
AND YOU MAY RECALL TESTING WAS
NOT WIDELY AVAILABLE AND AT THAT
POINT THE AVAILABILITY OF
TESTING WAS -- IN THE UNITED
STATES.
SO WE DID HAVE TO TURN PEOPLE
AWAY AT THAT POINT.
BUT AS TESTING BECAME MORE
WIDELY AVAILABLE WE DEVELOPED A
DONOR PROCEDURE TREATMENT
PROCEDURE.
ONE IS DOES THE DONOR MEET
ELIGIBILITY CRITERIA.
AND WHAT EVER THE CURRENT
CRITERIA WERE FOR COVID
CONVALESCENT.
THE PERIOD OF TIME ETC.
WHETHER OR NOT THE DONOR HAD
DETECTABLE SARS-CO- INDIVIDUAL 2
AND IF IT MET THE THRESHOLDS.
THAT WOULD DETERMINE WHETHER OR
NOT WE WOULD INVITE DONORS TO
COME BACK FOR FURTHER DONATIONS.
*.
OR PERHAPS TO DONATE OTHER BLOOD
PRODUCTS AND WE COULD CONTINUE
TO MONITOR THEM.
THE TRANSFUSION SERVICE FOR
LABORATORY WAS GREAT.
A LOT OF LOGISTICAL WORK ON
THEIR END TO MANAGE THE
INVENTORY AND TO DISTRIBUTE IT
TO THE FACILITIES WHEN THAT WAS
OCCURRING.
SO WHETHER OR NOT WE HAD FULL
STORAGE CAPACITY WOULD DETERMINE
IF WE COULD COLLECT MORE ETC.
AND THEN THERE WERE SOME DONORS
WHO WE THOUGHT WERE INTERESTING
AND THUS THE ADVANTAGE OF HAVING
THIS COLLECTION DONE UNDER A
PROTOCOL -- WE INCLUDED A
SECONDARY OBJECTIVE.
THE MONITORING RESPONSES IN THIS
COHORT OVER TIME AND THE DONORS
WERE VERY MOTIVATED IN
PARTICIPATING.
WE ELECTED TO COMMUNICATE WITH
THE DONORS WITH DISCLAIMERS
STATING THAT THE TESTS WERE
APPROVED UNDER EMERGENCY USE AND
THE INFORMATION IS TO GUIDE
WHETHER OR NOT YOU'RE ELIGIBLE
FOR FURTHER PLASMA DONATIONS.
BUT WE DID NOTICE THAT THE
COMMUNICATION WAS AN IMPORTANT
PART OF WHAT WE THINK
CONTRIBUTED TO THE RETENTION IN
THE PROGRAM AND THEY UNDERSTOOD
THAT THIS WAS AN EVOLVING
PROCESS AND THEY WERE EXCITED BY
THE OPPORTUNITY TO PARTICIPATE
IN WHAT THEY CONSIDERED THE
CUTTING EDGE.
AND WE'RE THANKFUL FOR THEIR
PARTICIPATION AND EXCITEMENT.
WE GENERALLY WERE EITHER
MODIFYING PROCEDURES -- BUT RISK
DID OCCUR AS WELL.
WE ENROLLED 236 SUBJECTS.
AGE 47 YEARS AND SIGNIFICANT
CAUCASIAN MAJORITY.
THAT IS TYPICAL OF THE ROUTINE
DONOR POPULATION AS WELL AS THE
U.S. GENERAL POPULATION AND THE
BLOOD GROUPS ALSO REFLECTED THAT
GROUP.
WE INITIALLY COLLECTED PLASMA
PARTICULARLY SINCE IN THE EARLY
DAYS THERE WERE NO ASSAYS
AVAILABLE AND IT WAS NOT CLEAR
WHAT WE WOULD NEED TO HAVE TO
QUALIFY PLASMA AS USABLE.
WE WOULD PULL OUT WHAT WAS
NEEDED AS THE CRITERIA EMERGED.
WE STOPPED COLLECTIONS IN MAY
MAY 2021.
THE SAMPLES WERE FOR INITIAL
EVALUATION OF THE DONOR SO WE
WOULD DRAW SAMPLES -- IF YOU'RE
A FEMALE DONOR --
[ AUDIO DIFFICULTIES ]
OR DO YOU HAVE VERY LOW ANTIBODY
LEVELS.
WE WERE ABLE TO COLLECT OTHER --
--
[ AUDIO DIFFICULTIES ]
WE COLLECTED 10% TO WHOLE BLOOD
DONATIONS AND MANY OF THOSE
DONORS CONTINUE TO DONATE WHOLE
BLOOD.
SO THOSE ARE NEW PEOPLE THAT WE
HAVE IN THE POOL WHICH WE'RE
THANKFUL.
WE REENTERTAINED SAMPLES THAT
COLLECTED FOR VALIDATION IN THE
BIOREPOSITORY AND WE WERE ABLE
TO COLLABORATE WITH GROUPS
INSIDE AND OUTSIDE
[ AUDIO DIFFICULTIES ]
WHAT DID WE DO WITH THE PLASMA
THAT WE COLLECTED?
WE COLLECTED PLASMA FROM ABOUT
163 OF THE DONORS AND COLLECTED
ABOUT 800 UNITS OF PLASMA.
THAT IS QUITE A LOT.
SO THE INVENTORY MANAGEMENT
WOULD LIKE TO THANK THEM FOR
THEIR HARD WORK.
AND EVEN THOUGH WE DISCONTINUED
IN MAY OF 2021 WE HAD THE
REPOSITORY OF PLASMA THAT WE
HOPED WOULD BE USEFUL TO THE
CLINICAL CENTER.
SADLY -- THE CENTER DID NOT USE
MUCH.
WE HAVE ONLY HAD FOUR PATIENTS
FOR WHICH CLINICIANS REQUESTED
THE PLASMA.
WE WERE ABLE TO PRACTICE DATA AT
MEETINGS AND IN COLLABORATION
WITH INFECTIOUS DISEASE.
AND WE WERE ALSO TO SHARE
SAMPLES OUTSIDE THE DTM.
THE NOVEL RED CELL -- ASSAY FOR
ANTIBODY COLLECTION WHICH WON AN
AWARD.
IT WAS REALLY -- JUST TO PROVIDE
THE SAMPLES AND THE DATA FROM
THE DONORS WE HAD COLLECTED BUT
HAVING THAT REPOSITORY AND THE
DETAIL DONOR HISTORY WAS HELPFUL
IN SOME OF THESE COLLABORATIONS.
SO THAT WAS ONE OF THE BENEFITS
OF STARTING THIS PROGRAM.
ONE OF MY REGRETS WAS THAT WE
WERE NOT ABLE TO ESTABLISH A
COLLABORATION -- THE DATA FROM
THE EAP --
[ AUDIO DIFFICULTIES ]
INDICATED THAT SEVERE ADVERSE
EVENTS WERE LOW INCLUDING
REACTIONS
[ INDISCERNIBLE ]
THEY CONCLUDED AS HAVE MANY
OTHERS CONCLUDED THAT
CONVALESCENT PLASMA IS SAFE OR
NO MORE DANGEROUS THAN ROUTINE
PLASMA TRANSFUSION.
THE COMMUNITY HAS INTERPRETED
THE STUDIES THAT HAVE BEEN
CONDUCTED TO INDICATE THAT THERE
IS NO SIGNIFICANT BENEFIT OF CCP
IN THE GROUPS THAT WERE
ANALYZED.
AND THIS IS REFLECTED IN THE
BIDE LINES.
-- GUIDELINES.
* AND THERE HAS BEEN SOME
ARGUMENT MADE THAT THERE MIGHT
BE SOME BENEFIT IN SOME
POPULATIONS PERHAPS OLDER
ADULTS.
THERI WON'T ATTEMPT TO COVER ALL OF
THE STUDIES THAT HAVE BEEN DONE.
AS SOMEONE INDICATED IN A RECENT
INTERVIEW THERE HAVE BEEN TWO
TRIALS LOOKING AT CONVALESCENT
PLASMA IN THE LAST TWO YEARS
THERE HAVE BEEN 25 COMPLETED.
SO THAT GIVES YOU AN IDEA OF HOW
MANY HAVE BEEN COMPLETED.
HOWEVER THERE ARE SOME WHO ARGUE
THAT VACCINATED DONORS MIGHT
PROVIDE
[ INDISCERNIBLE ]
THUS FAR SO WE SHOULD NOT MISS
THE OPPORTUNITY TO COLLECT WHAT
MIGHT BE THE BEST PRODUCT
AVAILABLE US TO.
I'VE INCLUDED A SCREEN SHOT HERE
FOR DETERMINING WHETHER OR NOT
THE VACCINATED OR UNVACCINATED
PLASMA DONORS COULD BE INCLUDED
FOR CCP DONATION TO GIVE YOU AN
IDEA OF THE COMPLEXITY OF THE
QUESTION AND THE MAJOR QUESTION
IS WHETHER OR NOT THE PLASMA
THAT WE COLLECTED WOULD BE
EFFECTIVE AGAINST ONE OF THE
CURRENT SARS-CoV-2 VARIANTS.
THERE ARE STILL ONGOING TRIALS
NOT PRY MAYBELY IN THE UNITED
STATES BUT IN THE * REST OF THE
WORLD.
THERE ARE OPEN STUDIES STILL IN
BRAZIL AND ITALY.
I'M GOING TO CLOSE BY LISTING
WHAT I CONSIDER THE LESSONS I
LEARNED.
THE DTM
[ INDISCERNIBLE ]
WAS ABLE TO RAPIDLY MOBILIZE A
POTENTIALLY THERAPEUTIC RESOURCE
IN A TIME OF GREAT UNCERTAINTY
AND WE WERE THANKFUL FOR THE
COLLABORATION OF THE TRANSFUSION
SERVICE LABORATORY MAKING IT
POSSIBLE.
THIS REQUIRED EXTENSIVE
COLLABORATION BETWEEN
TELEWORKING AND ON-SITE
PERSONNEL.
AND SIGNIFICANT ADAPTABILITY
AMIDST REGULATORY CHANGES.
[ INDISCERNIBLE ]
AND WE ALSO WERE HAPPY TO
WELCOME A NEW GROUP OF MOAT
INDICATED DONORS.
AND THIS ENTIRE EXPERIENCE TO ME
EMPHASIZED THE IMPORTANCE OF
COMMUNICATION.
I WOULD LIKE TO THANK -- AND
FINALLY OUR NIH BLOOD AND PLASMA CLASS
-- PLASMA DONORS.
THANK YOU SO MUCH FOR HAVING ME
TODAY PRESENTING TOGETHER WITH
DR. WEST.
I HAVE NOTHING TO DISCLOSE.
THE VIEWS EXPRESSED ARE MY OWN
AND DO NOT REFLECT THE NATIONAL
STUDENT OF HEALTH OR HUMAN
SERVICES OR THE U.S. FEDERAL
GOVERNMENT.
THOSE ARE THE OBJECTIVES OF MY
PRESENTATION.
WE'RE GOING TO BRIEFLY GO
THROUGH THE LANDSCAPE OF
COVID-19 SEROLOGICAL TESTS.
THE POLICY CHANGES.
OUR EXPERIENCE, VERY INTERESTING
DATA -- I'M SHOWING THIS BECAUSE
IN A FEW DAYS IT'S GOING TO BE
TWO YEARS SINCE IT WAS DECLARED
A PANDEMIC.
REPORTING GLOBALLY THE NUMBER OF
POSITIVE CASES IN LIGHT BLUE.
THAT IS IN ORANGE THE NUMBER OF
VACCINES AND YOU CAN SEE THE
NUMBER OF CONFIRMED CASES IN THE
U.S.
STILL SCARY AND REALLY
UPSETTING.
A BRIEF REVIEW ON -- TESTS.
IT'S COMPOSED BY PROTEINS.
OF THE FOUR MAJOR STRUCTURES --
THE PROTEIN "S" AND THE "N" --
BOTH HAVE BEEN WIDELY USED AS
TARGET ANTIGEN FOR SEROLOGICAL
ASSAY.
IF A PERSON TEST POSITIVE
TYPICALLY -- MEASURABLE
ANTIBODIES AROUND THE FIRST WEEK
I WOULD SAY THE FIRST 7-14 DAYS
AND BY THE WEEK THE THIRD WEEK
MOST PERSONSES THAT TEST
POSITIVE -- SPECIFICALLY IGM OR
ANTIS OR ANTIN -- WITHIN ONE
WEEK AND THEY CONTINUE TO
INCREASE OVER TIME.
THE SENSITIVE OF DETECTION
FASHION USING ANTIGEN ASSAY THEY
WILL DECREASE.
SPECIFICALLY THE SARS-CoV-2
ANTIBODIES MAY PERSIST FOR
MONTHS AND HOPEFULLY FOR YEARS.
RIGHT NOW THERE ARE 85
INDIVIDUAL EUA REDUCED FOR SEAR
LOGICAL TESTS.
TWO ARE NEUTRALIZING.
ANTIBODY ISO TYPES -- AND THE
RESULTS FORMAT CAN BE
QUALITATIVE.
I'M SHOWING THIS TABLE.
FROM THE CDC WEBSITE BECAUSE
THIS IS A FAIRLY USABLE TOOL.
MOST OF THE POPULATION IN THE
U.S. RIGHT NOW RECEIVED THE
VACCINE AND THE VACCINE HAS BEEN
BILLED SPECIFICALLY FOR THE
PROTEIN.
WHEN WE PERFORM A TEST WE CANNOT
DISTINGUISH IF THAT IS FREE OF
INFECTION.
SO HAVING AVAILABLE ALSO
ANTIBODY RESULTS CAN HELP
DISTINGUISH THE SITUATION.
EITHER IF WE'RE LOOKING AT
VACCINATED OR UNVACCINATED
STATUS OR UNKNOWN.
IT'S IMPORTANT TO HAVE THESE
TOOLS.
BUT AND THIS TABLE IS HELPING IN
AGAIN THAT WE RECEIVED SO MANY
QUESTIONS.
I THINK I'VE BEEN INFECTED.
CAN I HAVE THE SEROLOGY TEST?
IT'S GOING TO BE POSITIVE AND
IT'S NOT GOING TO TELL YOU
ANYTHING.
BUT THIS TABLE IS SIMPLE TO READ
AND VERY HELPFUL TOOL.
WE NEED TO BE CAREFUL IN
INTERPRETING THE RESULTS BECAUSE
THERE ARE PEOPLE THAT DON'T
DON'T HAVE ANTIBODY AS ALL.
WE DON'T KNOW WHEN AND IF THE
ANTIBODIES WILL WANE OVER TIME.
SO THE FACT THAT THE PERSON CAN
BE NEGATIVE FOR -- N DOES NOT
MEAN THAT THE PERSON WAS
INFECTED BEFORE.
SO WE NEED TO BE CAREFUL IN
INTERPRETING BUT STILL A GOOD
TOOL.
LET'S LOOK AT WHAT HAPPENED
DURING THE THESE PAST TWO YEARS
AND SPECIFICALLY AT THE
CONVALESCENT PLASMA
QUALIFICATIONS UNDER THE
CONSTANT CHANGE OF THE FDA
POLICIES.
THERE ARE SEVERAL APPROACHES
THAT HAVE BEEN USED FOR
QUALIFICATION.
THERE WERE NO AVAILABLE TESTS AT
ALL.
AND IF I LOOK BACK IT SEEMS LIKE
20 YEARS HAS PASSED BUT IT'S
ONLY TWO YEARS.
AND THERE WAS NOTHING.
SO THE FDA WAS SAYING COLLECT
PLASMA WHEN ANY TEST WOULD BE
AVAILABLE WE CAN GO BACK AND
CHECK.
ANTIBODIES CAN BE MEASURED.
IT MEASURES BINDING USING ELISA
OR CHLIA.
THE MEASUREMENT IS GENERALLY
QUANTITATIVE.
YOU CAN HAVE THE KIND OF
QUANTIFICATION OF ANTIBODIES.
BUT CANNOT BE DEFINED AS A
TIGHTER.
THOSE ARE THE ONE THAT'S CAN BE
--
[ INDISCERNIBLE ]
THEY REQUIRE SPECIALIZED
EXPERTISE AND PERSONNEL.
THEY ALSO ARE VERY DIFFICULT TO
-- ACROSS DIFFERENT LOGISTICALLY
COMPLEX.
AND THEY ARE TIME-CONSUMING.
SOME OF THEM NOW FIVE DAYS BUT
STILL IT'S A LONG TIME.
SEROLOGICAL BINDING ASSAY --
THESE ARE EASIER TO PERFORM.
THEY CAN BE AUTOMATED.
THE MOST USED TO QUALIFY THE
CONVALESCENT PLASMA UNIT.
I DON'T WANT TO GO THROUGH IN
DETAIL ON THIS SLIDE.
AS DR. WEST GAVE US ALREADY --
IN DETAIL OVERVIEW OF THIS.
I JUST WANT TO POINT OUT IN
TERMS OF TESTING REQUIREMENT
FROM FDA DURING THESE PAST TWO
YEARS.
WHAT HAPPENED WAS AGAIN AT THE
BEGINNING WHEN -- THE HOSPITAL
WAS COLLECTING PLASMA THE FDA
WAS SUGGESTING RECOMMENDING TO
TEST THE UNIT WAS NOT REQUIRED.
AND AGAIN BACK THEN THERE WAS
NOTHING AVAILABLE.
SO THE FIRST TEST THAT WAS
RELEASED AND RECEIVED THE EUA
WAS THE AUTO DIAGNOSTIC.
AND THAT HAPPENED BASICALLY IN
APRIL.
AFTER A FEW MONTHS FROM MAYBE TO
AUGUST MANY DATA WERE GENERATED
ON THE CONVALESCENT PLASMA UNIT.
A CROSS LABORATORY COMPARISON
SHOWED THAT SARS-CO- INDIVIDUAL
2IG SPECIFIC TEST WAS
CORRELATING WITH THIS
NEUTRALIZING ASSAY THAT WAS DONE
FROM THE INSTITUTE IN UK AND
COMPARING THESE TWO SET OF DATA
THERE WAS CLEAR THERE WAS A
VALUE FOR THE AUTO DIAGNOSTIC
TEST.
THERE WAS INDICATED THAT IT WAS
A GOOD MATCH BETWEEN IG AND
NEUTRALIZING LEVEL SO FDA
RELEASED THIS NEW REQUIREMENT
WHERE THE UNITS THE CONVALESCENT
PLASMA UNIT THAT WAS COLLECTED
THEY NEEDED TO BE QUALIFIED AS
LOW TIGHTER AND HIGH TIGHTER.
BUT THEN AGAIN IN FEBRUARY
BECAUSE MORE AND MORE
SATISFACTORY LOGICAL ASSAY WERE
RECEIVED AND MORE DATA WAS
PRODUCED AND THERE WAS A BIG
COLLABORATION -- THIS VALUE WAS
CHANGED AND ALSO THERE WAS NO
LOW AND HIGH TIGHTER ANY MORE.
THEY NEEDED TO BE JUST CALLED
HIGH TIGHTER AND BY
DECEMBER 2021 ALL COVID-19
CONVALESCENT PLASMA TRANS FUSED
WAS QUALIFIED WITH QUANTITATIVE
ASSAY.
THOSE ARE THE ASSAY -- THE NINE
THAT RECEIVED THE EUA FROM THE
FDA THAT WAS APPROVED TO QUALIFY
THE PLASMA FOR CLINICAL USE IN
HOSPITALIZED PATIENTS AND THEY
NEED TO BE LABELED AS HIGH
TIGHT.
AS YOU CAN SEE EACH SYSTEM IS
REPORTING RESULTS IN UNIQUE
UNITS AND HERE IT IS REPORTED
THE VALUE THAT IS NEEDED TO
QUALIFY THE CONVALESCENT PLASMA
UNIT ACCORDING WITH THAT TEST.
IN OUR CASE WE'VE BEEN NOW
QUALIFYING THE PLASMA, THE
REMAINING ONE WITH AUTO
QUANTITATIVE IGG ASSAY.
LET'S SEE HOW THIS WAS CHANGING
OUR EVERY DAY WORKFLOW.
BECAUSE I THINK THAT IS THE MOST
IMPORTANT PART.
I WILL RECALL THIS INTERESTING
STORY SO DR. WEST AGAIN SHE
DECIDED TO IMPLEMENT THE
COLLECTION AND SHE CALLED ME.
I'M WRITING THE PROTOCOL BUT I'M
NOT SURE HOW WE'RE GOING TO
QUALIFY THIS UNIT.
WAS ALREADY KNOWN THAT WE DON'T
KNOW IF THIS PATIENT THIS DONOR
THAT THEY GOT INFECTED.
THEY DEVELOPED ANTIBODIES.
WE KNOW NOTHING ABOUT THAT.
SO CAN YOU PLEASE HELP ME IN
QUALIFYING THE UNIT?
AND OF COURSE I SAID SURE.
I WILL HELP YOU BUT IN REALITY I
KNEW THERE WAS NOTHING THAT I
COULD DO AT THAT MOMENT.
SO WE STARTED LOOKING AROUND.
WE STARTED CONTACTING OUR THE
COMPANY -- PROVIDING ALL OF THE
KEYS FOR OUR DIAGNOSTIC LAB AND
THERE WAS ABSOLUTELY NOTHING.
SO WE DECIDED OKAY WE'RE GOING
TO TRUST AND DEVELOP IN OUR OWN
TEST WE'RE GOING TO DEVELOP A
LAB BASED TEST AND BY THE TIME
WE WERE READY TO DO THAT FDA
GRANTED THE FIRST EUA TO THE
AUTO DIAGNOSTIC AND WE WERE SO
LUCKY BECAUSE THE -- THIS IS THE
SYSTEM THAT WE USED.
WE'VE IMPLEMENTED FOUR
SEROLOGICAL ASSAYS.
AND ALSO MOST IMPORTANTLY A TRUE
-- COLLABORATION WE WERE ALL OF
US ALL OF THE SCIENTISTS WE WERE
ABLE TO FIND THIS GROUP THAT IS
IN FREDERICK THAT WAS WILLING TO
TEST FOR NEUTRALIZING
ANTIBODIES.
JUST GIVING ANOTHER VIEW OF THE
IGG.
THE TECHNIQUE THAT INVOLVES TWO
STAGE REACTION.
IN THE FIRST STAGE WE HAVE
ANTIBODY TO SARS THAT ARE
PRESENT IN OUR SAMPLES THAT ARE
BINDING TO SARS-CO- VERY 2 SPIKE
PROTEIN AND IN THE SECOND STAGE
LABELED MONO CLON -- MONOCLONAL -- WE ADD
A SUB STRAIGHT.
AND THAT SIGNAL CAN BE
TRANSFORMED INTO A NUMERICAL
VALUE.
THIS IS GIVING RESULTS IN THE
FORM OF SIGNIFICANT OF VALUE.
IF THE VALUE IS BELOW ONE THE
TEST IS -- REACTIVE.
IF IT'S GREAT THEN THE TESTING
CALLED REACTIVE.
THIS IS JUST TO REFRESH THE
MEMORY.
AND THEN IN APRIL 21 FDA SORRY
IN APRIL 21 THE AUTO WAS THE
FIRST ONE RECEIVING THE EUA --
IN JULY 21 AGAIN AUTO DIAGNOSTIC
WAS THE FIRST RECEIVING FOR THE
QUANTITATIVE ASSAY.
SO THE U.S. IS THE ONLY ONE.
DIFFERENT STORY FROM EUROPE
WHERE MOST OF THE TESTS ARE
REFERRING TO THE STANDARD.
IN AUGUST WE WERE ASKED TO LABEL
OUR UNITS AS HIGH TIGHTER AND
THE UNIT THAT WAS CALLED HIGH
TIGHTER IS THE SIGNAL TO CUT OFF
RATIO.
IN FEBRUARY THAT NUMBER WAS
CHANGED AGAIN AND WAS REQUIRED
TO BE 9.5.
AND NOW IN DECEMBER THE HIGH
TIGHTER IS WHEN WE HAVE A
QUANTIFICATION AND THE
QUANTIFICATION IS --
[ INDISCERNIBLE ]
GREATER OR EQUAL TO 200.
BY THE TIME AND DR. WEST WAS
EXPLAINING TO YOU THIS WAS
REALLY CHALLENGING.
BY THE TIME FDA WAS CHANGING WAS
ASKING US TO LABEL OF COURSE WE
HAD MOST OF OUR UNITS ALREADY
LABELED.
[ INDISCERNIBLE ]
WE HAD TO GO BACK AND LOOK
ACROSS THE 500 UNITS THAT HAD
BEEN COLLECTED AT THAT POINT.
HOW MANY OF THOSE THAT THE
SIGNIFICANT VALUE OF 12 THAT
COULD BE CLASSIFIED AS HIGH
TIGHTER.
WE WERE LUCKY BECAUSE 185 OR 37%
OF THE UNIT -- IT WAS GREATER
THAN 12 SO IT COULD BE LABELED
AS HIGH TIGHTER.
AND THAT NUMBER THE NEUTRALIZING
NUMBER IS WHAT IS THE THE
BEGINNING AGAIN WHEN THERE WAS
NO SEROLOGICAL TEST AVAILABLE
WAS INDICATED AS A GOOD NUMBER
AS A GOOD TIGHTER ACCEPTABLE
TIGHTER.
SO MOST OF THE UNIT -- REQUIRED
BY FDA --
[ INDISCERNIBLE ]
THAT WAS PRETTY MUCH MATCHING.
SO THE TWO ASSAY WERE
CORRELATING PRETTY WELL.
AND THEN OF COURSE WE CHANGED TO
9.5 SO WE HAD TO GO BACK AND DO
THE SAME THING.
THIS TIME 242 OF THE UNIT SO WE
HAD AN INCREASED NUMBER -- 48%
OF THE UNIT -- AND 66% OF THOSE
ALSO HAD GOOD NEUTRALIZING
TIGHTERS.
THEY WERE FUNCTIONING PRETTY
WELL.
IT WAS VERY GOOD SURPRISE.
BUT THEN WE HAD TO MOVE ON THE
QUANTIFICATION ASSAY.
SO WE HAVE REALLY FEW UNIT THAT
ARE NOT EXPIRED YET IN OUR
REPOSITORY.
AND WE WENT BACK TO QUANTIFY
SOME OF THESE UNITS AND
INTERESTING ALL OF THE UNITS
THAT THEY HAD -- A VALUE OF LESS
THAN 9.5 THEY DID NOT QUALIFY AS
YOU CAN SEE FROM THIS PLOT.
BUT THE ONE THAT WERE GREATER OR
EQUAL TO 9.5 THEY COULD QUANTIFY
SO ALMOST ALL OF THEM -- HAD A
VALUE OF BAU OF 200.
WE WERE CURIOUS TO SEE -- --
CORRELATING THESE RESULTS.
THE RED DOTS -- THEY ARE THE BAU
THAT IS EQUAL OR GREATER THAN
200.
AND ALSO THE NEUTRALIZING
TIGHTER FOR ALMOST ALL OF THEM
IS PRETTY HIGH SO WE'RE ABOVE
180 SO GOOD CORRELATION WITHIN
THE TESTING.
WE HAVE BEEN USING.
WE ARE NOW FACING A NEW PROBLEM
WITH THE QUANTIFICATION.
7 SO AGAIN IGG-QUANT -- TO USE
THE TEST WITHOUT ANY DILUTION SO
WE CANNOT MAKE DILUTION.
WHEN WE WERE LOOKING AT THE DATA
IN UNVACCINATED CONVALESCENT
PLASMA DONORS WE WERE REALIZING
THAT LOOKING AT NEUTRALIZING
ANTIBODIES THE TWO DIFFERENT
SAMPLES -- THEY ARE DIFFERENT
NEUTRALIZING ANTIBODIES.
PARTICULARLY VACCINATED DONORS
THEY HAD SKY HIGH NIGHT LIGHTING
TIGHTER.
NEUTRALIZING TIGHTER.
*.
THE READING IS FOR ABOVE 200.
YOU CAN SEE HOW THE VACCINATED
IGG QUANTIFICATION IS MUCH
HIGHER AND THAT IS CONFIRMED BY
NEUTRALIZING TIGHTER BUT ALSO
ANTIBODY TESTS.
THE IGG IS NOW CONFIRMING THAT
BECAUSE I BELIEVE THERE IS A
KIND OF LIMIT IN THE TEST.
THERE ARE TOO MUCH IGG IN THE
SAMPLES AND IT'S LIKE THERE IS A
KIND OF SATURATION EFFECT SO THE
PROCESS CANNOT DETECT WHAT IS
THERE IN REALITY.
WE ALSO EXTENDED THIS
OBSERVATION ON MORE SAMPLES.
AND AS YOU CAN SEE THE ONE WITH
THE HIGH NEUTRALIZING PATTERNS
WERE THE ONES -- DILUTION.
SO THIS IS SOMETHING THAT IS
BEING DISCUSSED AND WITH THE ABB
THERE ARE MANY GROUPS WORKING ON
THIS AND WE TRY TO GATHER AS
MUCH DATA AS POSSIBLE BECAUSE
THERE IS NEED FOR CHANGE IN THIS
ASSAY.
WE CONDUCTED THE LONGITUDINAL
SATISFACTORY LOGICAL ASSESSMENT
OF 228 CONVALESCENT PLASMA
DONORS AFTER RECOVERY.
THETHEY WERE ASSESSED FOR THE
LEVEL.
AT THE FIRST STUDY WE SEE THE
DONORS PRESENTED THE MEDIAN OF
47 DAYS FOR SYMPTOM RESOLUTION
AND WE OBSERVED THE HIGH RATE OF
CONVERSES FOR TOTAL.
AS YOU CAN SEE IN THE PLOT 97%
PRESENTED ANTIBODIES.
AND 72% NEUTRALIZING.
THE MAJORITY OF THE DONORS HAD
MODEST ACTIVITY.
BUT WE COULD MEASURE THAT AND
THAT WAS GOOD.
THE DONOR THEY COME BACK FOR --
A REPEAT STUDY VISIT.
SO THEY AS DR. WEST WAS SAYING
WE'VE AMAZING DONORS.
THEY ARE WILLING TO COME BACK.
AND THEY WERE COMING BACK.
WE HAVE SOME OF THEM LIKE NINE
TIME POINTS THEY WERE COMING
BACK AND LET US LOOK AT THEIR
ANTIBODIES.
WE FOLLOWED THEM FOR UP TO
ELEVEN MONTHS.
THE FIRST WAS AT 42 DAYS.
THE FINAL WAS 196 DAYS BUT WE -- WE
WENT UP TO ELEVEN MONTHS.
THIS IS A PUBLISHED PAPER AND
YOU CAN HAVE ACCESS TO THIS.
71%, THEY HAD A DECREASED VALUE
BUT WE WERE STILL ABLE TO DETECT
AGG AND 4% HAD NO CHANGE.
IG WAS PRETTY STABLE.
FOR UP TO ELEVEN MONTHS.
WHEN WE WERE LOOKING AT
NEUTRALIZING TIGHTER IF WE
LOOKED AT IT WE WERE OBSERVING
THAT 37% OF THE DONORS HAD NO
TIGHTER.
THEY LOST --
[ INDISCERNIBLE ]
BUT WHEN WE STRATIFIED -- THE
SITUATION CHANGED.
AND IN THE HIGH STARTING TIGHTER
DONOR WE HAVE HIGH NUMBER OF
DONORS THAT STILL HAVE
ANTIBODIES PRESENT OVER ELEVEN
MONTHS.
SO -- NEUTRALIZING ANTIBODIES --
LOOKS LIKE THEY PERSIST IN
HEALTHY PEOPLE OVER ALMOST THE
FIRST YEAR.
WE ARE KEEP FOLLOWING SOME OF
THE DONORS.
WE HAVE 116 OF THE 228.
THEY DIDN'T GET VACCINATED.
IF YOU SEE ON THIS PLOT WE HAVE
DATA POINT THAT GOES OVER 600
DAYS FOR SYMPTOM RESOLUTION.
THE RED ARROW IS INDICATING WHEN
YOU ARE OBSERVE AN IGG LEVEL OFF
THAT IS ALMOST AT ONE YEAR FROM
THE LAST DAY OF SYMPTOM
RESOLUTION.
AND REALLY WE'RE FOLLOWING THEM.
THERE IS ONLY ONE THAT IS
INDICATED WITH THE SQUARE THAT
LOOKED LIKE THERE IS A SPIKE.
WE'RE HAVING IS THIS.
PROBABLY THIS PERSON GOT
INFECTED SO WE NEED TO MAKE SURE
THAT THAT AGAIN USING THE "N"
ANTIBODIES IF THERE WAS AN
INFECTION.
BUT STILL VERY ENCOURAGING.
WE ARE ALSO FOLLOWING OUR DONORS
THAT GOT VACCINATED.
I'M SHOWING ONLY J&J VACCINE AND
YOU CAN CLEARLY TELL WHEN THE
DONORS RECEIVED THE VACCINE.
THERE IS A CLEAR SPIKE.
IN IGG ON THE LEFT SIDE AND
NEUTRALIZING ON THE RIGHT SIDE.
WHAT WE'RE NOW DOING -- WE'RE
KEEP CHARACTERIZING THE
EVOLUTION OF ANTIBODY ACTIVITY.
I THINK THERE IS STILL A LOT WE
NEED TO LEARN IN TERMS OF ASSAY.
SO WE'RE TRYING TO UNDERSTAND
HOW THE TIGHTER THE TARGET THE
VARIANTS ARE IN SOME WAY
IMPACTINGS THE TESTING RESULTS.
WE ARE ALSO CORRELATING THE
VITRO -- QUANTITATIVE ASSAY.
WITH NEUTRALIZING ASSAY.
OUR SAMPLE CORE IS VACCINATED
CONVALESCENT PLASMA DONOR.
WE HAVE ALMOST 150 DONORS THAT
ARE WILLING TO COME BACK.
WE HAVE NONVACCINATED
CONVALESCENT DONORS.
WE HAVE 13 AND THEN WE HAVE --
VACCINATED DONOR.
IN CONCLUSION AS DR. WEST WAS
POINTING OUT THIS WAS A BIG
LEARNING EXPERIENCE.
I DON'T KNOW WHEN IT'S GOING TO
HAPPEN AGAIN THAT WHILE YOU'RE
TESTING YOU'RE LEARNING THAT
THAT TEST IS NOT WORKING
PERFECTLY.
YOU HAVE TO MAKE ADJUSTMENT.
YOU HAVE TO GO BACK AND RETEST
AGAIN.
WORKING WITH SO MANY SCIENTISTS
AROUND THE WORLD EXCHANGING
DATA.
EXCHANGING THOUGHTS AND ALL
WORKING FOR THE SAME CAUSE.
THAT WAS SOMETHING ABSOLUTELY I
WOULD SAY AMAZING.
ALSO THAT WAS A BIG CHALLENGE ON
THE REGULATORY STANDPOINT.
BECAUSE WE HAD TO CHANGE THREE
TIMES OUR QUALIFICATION CRITERIA
FOR THE CONVALESCENT PLASMA UNIT
AND THAT WAS A BIG CHALLENGE.
NOT ONLY -- IN PROVIDING THE
DATA BUT ON THE REGULATORY SIDE
THAT WAS PAINFUL AND OF COURSE
ALL THE GROUP THAT DR. WEST WAS
MENTIONING WE WERE REALLY
WORKING AS ONE TEAM.
IT WAS A LOT OF WORK.
ALSO WANT TO POINT OUT THAT CCP
DONOR THEY ARE A HIGHLY VALUABLE
COURT BECAUSE THEY MAY RETURN
FOR REPEAT DONATIONS.
SO THEY ARE PROVIDING AN
OPPORTUNITY TO CHARACTERIZE
SARS-CoV-2 SEROLOGICAL
RESPONSE.
SO WE HAVE CLINICAL INFORMATION.
WE HAVE THIS FANTASTIC DONORS
THAT THEY COME MONTHLY.
SO I THINK THIS IS AN IMPORTANT
TOOLS.
THAT WE NEED TO KEEP FOLLOWING.
AND STUDYING AND WITH THIS I
WANT TO THANK MY FANTASTIC
GROUP.
THE INFECTIOUS DISEASE SECTION.
THEY WERE ESSENTIAL FOR ALL OF
THE DATA I'VE SHOWN YOU TODAY.
I WANT TO THANK DR. WEST'S
GROUP, -- THEY ARE ABSOLUTELY A
TREASURE.
NIAID GROUP.
AND OF COURSE OUR DEPARTMENT
CHIEF.
FOR HELPING US TO NAVIGATE
THROUGH ALL OF THESE REGULATORY
CHANGE.
WITH THIS I'LL STOP SHARING.
I HOPE WE HAVE TIME FOR
QUESTIONS.
>> DR. WEST AND DR. DE GIORGI.
WE'RE AT THE HOUR SO WE WILL NOT
BE ABLE TO ENTERTAIN ANY
QUESTIONS.
BUT SEEING YOUR OWN WORK IN
PROGRESS -- IN THIS RAPIDLY
EVOLVING FIELD IS BOTH
APPRECIATED AND APPLAUDED AND WE
WANT TO THANK YOU VERY MUCH FOR
PRESENTING YOUR VERY IMPORTANT
WORK TO THE COMMUNITY.
THANK YOU EVERYONE AND WISH
EVERYONE A GOOD AFTERNOON.
THANK YOU.