© 2013 Winton Gibbons

As Health Care Systems Worldwide Evolve, So Do Sourcing, Testing and Distribution of Blood for Donation

Family Limited volunteers

Volunteer, required, and paid

Volunteer

Patient history and ABO matching

Serology

Homebrew nucleic acid

testing

Centralized nucleic acid

testing

At use Local clinic | hospital

Mixed site and

distribution

Broad distribution

Donor registers

Health history and mini physical

1 pint of blood and several small test tubes collected

Bag, test tubes and the donor record labeled with identical bar code

Donation stored in iced coolers until transported to a center

Donated blood scanned into database, and test tubes sent for testing in

parallel

Most blood centrifuged into transfusable components – red cells,

platelets, and plasma

Primary components like plasma, can be further manufactured into

components such as cryoprecipitate

Red cells leuko-reduced

Single donor platelets leuko-reduced and bacterially tested

Test tubes received (one of five Red Cross National Testing Laboratories)

Dozen tests performed on each unit of blood – establishes blood type, and tests

for infectious diseases

Test results transferred electronically to manufacturing facility within 24 hours

If test result positive, unit discarded and donor notified. Results confidential and shared with donor, except as required by

law

Blood is available to be shipped to hospitals 24 hours a day, 7

days a week

When test results received, units suitable for transfusion labeled

and stored

Red Cells stored in at 6º C up to 40 days

Platelets stored room temperature in agitators up to 3-5 days

Plasma and cryo frozen and stored in freezers up to 1 year

Even Developed Process has Some Potential Left

$100

$1,000

$10,000

$100,000

$10 $100 $1,000 $10,000

GD

P /

capi

ta

Healthcare spending / capita

$100

$1,000

$10,000

$100,000

$10 $100 $1,000 $10,000

GD

P/Ca

pita

HC Spending/Capita

China-High

China-Medium

India-Medium

India-Low

0.0%

0.1%

1.0%

10.0%

100.0%

$10 $100 $1,000 $10,000

HIV

Pre

vale

nce

Healthcare Spending / Capita

High-High

How-Mid

High-Low

Medium-High

Medium-Mid

Medum-Low

Low-High

Low-Mid

Low-Low

High Medium

Low 0%

20%

40%

60%

High Mid Low

Perc

ent o

f Pop

ulat

ion

High Mid Low High 1% 0% 19% Medium 0% 10% 59% Low 1% 3% 8%

$451

$348 $90

$399

$280

$2,122

$604

Developed-equivalent low HC $ / capita

Developed-equivalent mid HC $ / capita

Non-tracked NAT not adopted

Tracked NAT not adopted

Other

Roche

Novartis | HOLX

57,000,000 9,676,437

55,000,000 143,500,659

40,822,904

High

Medium

Low

Donations tested Donations not tested Potential donations

Donation  Systems  in  Developing  Countries  Show  Clinical  Need    

•  50% of donations in high-income countries with only 15% of the world's population. This implies a total equivalent, potential market of 310 million donations at a similar donation rate for all countries.

•  39 countries (of 159 reporting) unable to screen all blood donations for one or more of these transfusion-transmissible infections: HIV, hepatitis B, hepatitis C and syphilis.

•  Only 13% of low-income countries have a national hemovigilance system to monitor and improve safe blood transfusion.

Source: WHO, American Red Cross, AABB, CIA Factbook, various companies public presentations

Donation  in  US  Could  still  be  Increased  

•  Donations –  10.8 million volunteers donate blood each year –  17 million units of whole blood and red blood cells –  29 percent of which are first-time donors

•  Who donates blood? –  Only 38 % of the US population eligible –  Less than 10 percent do so annually. –  Patients scheduled for surgery may be eligible to donate blood for

themselves(autologous blood donation)

International  Blood  Donations  Provide  Testing  Opportunities  

•  92 million blood donations every year •  50% collected in high-income countries with only 15% of the world's population, leading to

a developed-country total equivalent market of 310 million donations. •  Approximately 8,000 blood centers in 159 countries report on blood donations. •  Average, annual blood donations per blood center in high-income countries is 30,000

versus 3,700 low-income countries •  Only 62 countries have national blood supplies entirely from voluntary, unpaid blood

donations.

Neglected  Tropical  Diseases  (NTDs)  •  Babesiosis •  Buruli ulcer •  Chagas disease •  Cysticercosis •  Dengue fever •  Dracunculiasis (Guinea Worm

Disease)* •  Echinococcosis •  Fascioliasis •  Human African Trypanosomiasis

(African Sleeping Sickness)

•  Leishmaniasis •  Leprosy (Hansen's disease) •  Lymphatic filariasis* •  Malaria •  Onchocerciasis* •  Rabies •  Schistosomiasis* •  Soil-transmitted Helminths (STH)

(Ascaris, hookworm, and whipworm)*

•  Trachoma* •  Yaws

Targeting  Should  Occur  in  Highest  Population  at  the  Right  Stage  of  Economic  Development  

Example: Target Countries with Medium HC Spending / Capita and >1% HIV

Obviously other issues, such as political and regulatory considerations are also important

Example: Country Prioritization by HIV Prevalence

China  and  India  Should  be  Considered  by  Region,  Not  in  Total  

Rough Donations and Testing by Healthcare Spending / Capita

Nucleic  Acid  Testing  Potential  Substantial  at  Current  Equivalent  Price  of  $14  per  Donor