FIND SPECIMEN BANK Q1 2019 – Q4 2020 Activity Report & Updates

Photo: FIND / Ben Phillips

Q1 2019 - Q4 2020 Activity Report & Updates

FIND Specimen Bank

FIND manages a high-quality biorepository with over 480,000 well-characterized samples from more than 14,500 participants enrolled in over 25 sites across the globe. This unique resource is able to provide specimens to support product development efforts across four of FIND’s focus areas: TB (60% of samples), malaria (28%), non-severe acute fever management (6%) and hepatitis C (6%). Sample types include sputum, urine, plasma, serum, PAXgene, cell free DNA urine and cell free DNA blood. All specimens are collected at qualified clinics, under a protocol approved by an Institutional Review Board and with informed consent from patients.

About FIB

Since July 2020, FIND has been supporting a network of strategically positioned biobanks − FIND Integrated Biobanks (FIB) − across Africa, South East Asia, South America and Europe. Working together with our partners, the aim of this network is to build capacity for inclusive, ethical, and efficient biobanking services − improving access to high-quality samples.

FIND’s network of integrated biobanks enables for sample collection and distribution to be mobilized locally in response to user need. All ethical, legal and regulatory frameworks are overseen by FIND, who provides the resources, training and support needed to standardize services and makes sure quality benchmarks are met. This helps to ensure the availability of high-quality samples with requests managed through a single point of contact that streamlines distribution and harmonizes resources ready for deployment.

Photo: FIND/Katie G.Nelson

COVID-19 biobank activitiesFIND is conducting a prospective study to collect and store bacteriologically and clinically well-characterized reference materials of adult COVID-19 suspects in Peru. Up to December 2020, 253 participants were enrolled at UPCH (Peru). 72 participants were SARS-Cov-2 positive and 148 were SARS-Cov-2 negative (confirmed with PCR results at baseline and week 1 visits). A total of 33 participants were classified as inconclusive/invalid and did not have their results entered in the database. Of these, 15,451 aliquots were collected at baseline visits, 3,059 at week 1, 410 at week 2, 1,875 at week 4, 61 at week 5, 1,446 at week 8, and 63 at week 9. All samples are stored and available for distribution.

*

53 51 52

Distribution of material requests

2019

Number of MRFs** submitted*

Number of MRFs approved*

Number of MRFs distributed*

*Some MRFs were approved the previous year but aliquots were distributed the following year.

**request forms

Distribution of samples

Number of aliquots approved*

Number of aliquots distributed*

3

9,1998,94110,56812,570

Number of aliquots approved*

Number of aliquots distributed*

68 54 54

20202019

2020

Distribution of specimens

Between Q1 2019 – Q4 2020, the FIND specimen bank distributed 19,767 aliquots, fulfilling 106 requests. See the graphs below for details.

Number of MRFs submitted*

Number of MRFs approved*

Number of MRFs distributed*

Distribution of specimens per type

2020

2019

Serum: 3,295

Plasma: 2,450

Blood: 2,217

Urine: 968

Sputum: 624

Culture isolate:

605

Saliva: 339

PBMC: 70

Urine: 3,010

Plasma: 1,909

Blood: 923

Serum: 1,122

Sputum: 1,560

Culture isolate:

560

Saliva: 115

Legend

Urine

Plasma

Saliva

Blood

Sputum

PBMC

Culture isolate

Serum

4

Specimen inventory

The FIND repository currently holds 481,644 aliquots from collection sites in Cambodia, Cameroon, Côte d’Ivoire, Georgia, Greece, Moldova, Nigeria, Peru, Senegal, South Africa, Tanzania, the United Kingdom, Uganda, Ukraine and Viet Nam. FIND also manages the WHO-TDR TB collection, which includes 28,347 aliquots from Spain, The Gambia, El Salvador, Peru, South Africa, Tanzania, Uganda, Viet Nam, Canada, Bangladesh, Brazil, Colombia , and Kenya.

5

Viet NamGreece

Georgia

Ukraine

Cameroon

Côte d'Ivoire

South Africa

Peru

United Kingdom

7905

1650

931

2083

8831

184510991016

1930

Senegal

Cambodia

Tanzania

Uganda

Nigeria

Moldova

HCV: 4,976 specimens Malaria: 11,400 specimens TB: 10,936 specimens

Incoming specimens 2020

Legend

HCVMalariaTBPre-existing inventory

Culture isolate: 5242

Saliva:22,558

Blood:100,879

Urine: 5,311

Malaria: 133,990 specimens TB: 288,226 specimens

Culture isolate:45,461

DNA:9,939Plasma:46,693

SalivaBlood: 7,375Serum:47,178

Sputum:75,356

Urine:56,174

Saliva: 50

Plasma:10,212

Blood:11,243

Serum: 6,749

Urine:2,868

Fever: 31,072 specimens HCV: 28,356 specimens

Plasma:25,471

Blo

od: 2

,132

Seru

m: 7

53

Specimen inventory

6

Revenue

As FIND is a non-profit organization, requestors are asked to cover all shipping costs. We also charge a small handling fee per sample (US$ 50–200 depending on the sample type and characterization) towards operational activities. FIND received 334,919 US$ from material requesters between 2014 and September 2020.

Strains/DNA isolates and matching specimens

Specimens from MDR/XDR-TB patients were collected from globally representative sites in South America, South East Asia, Africa and Eastern Europe. These include sputum, plasma, serum and PAXgene tubes. Strains are characterized by whole genome sequencing and phenotypic testing against first- and second-line drugs and the minimum inhibitory concentration. Over 1,000 strain isolates are currently available.

Number and type of specimen Number of MDR/XDR participants

10,532 Sputum aliquots

7,311 Serum aliquots

8,785 Plasma aliquots

391 Paxgene aliquots

5,729 DNA aliquots

17,506 culture isolates

1,227 participants

1,271 participants

1,271 participants

391 participants

753 participants

754 participants

7

Quality control

To improve quality and ensure high standards, FIND implemented quality control and quality assurance processes for blood, sputum, and urine samples. Including recording critical data about the collection, conducting additional baseline testing, and applying stringent monitoring of storage conditions and processing times. For instance, baseline testing of urine samples with dipsticks is now allowing documentation of the physical characteristics of the sample and presence of proteins, glucose, ketones, haemoglobin, bilirubin, urobilinogen, acetone, nitrite, and leucocytes.

Information on materials distributed per requester

Photo: FIND/Katie G.Nelson

2019

Fever

HCV

Malaria

9

0 50 100 150 200 250 300

Molbio Diagnostics Pvt. Ltd. Karnataka

NBCL, B.V.

Chembio Diagnostics Systems, Inc.

Qorvo

Mologic Ltd.

DCN Diagnostics 167

135

97

87

70

10

0 250 500 750 1000 1250 1500 1750

Meso Scale Diagnostics

MICROSYNTH

Inflammatix

NMI 1650

512

511

184

Requesters

0 50 100 150 200 250 300 350 400 450 500 550 600

Mologic Ltd.

Global Good Funf (GGF)

Lab. Malaria (309) LID

Access Bio, Inc

PATH

MICROSYNTH [570]193188189

[394]244150

125

72

60

60

Requesters

Requesters

Urine PlasmaSalivaWhole blood

Legend

Aliquots distributed

Aliquots distributed

Aliquots distributed

TB

10

0 150 300 450 600 750 900 1050 1200 1350 1500

NRL Australia

PHRI

NHLS

ITRC

NIRT

QUIDEL

GenEndeavor

Gigabiomol

Hain Lifescience GmbH

PATH

San Raffaele

Research Center Borstel

David Wright Laboratory

Biomerieux

DCN Diagnostics

Proteogenix

ZeptoMetrix Inc.

Stony Brook University

Biotem

Unima

NJH

QMRL

Pace Diagnostics

Cepheid AB

NMI

Meso Scale Diagnostics

Wyss Institute of Harvard University 1300 [1400]100

480

455

440

420

407

400

270

100 100

50 505050

[200]

[200]

200

70 50 [120]

110

100

100100

93

80844 [52]

3010 [40]

50

2020 [40]

3830

20

10

4

Requesters

Urine Plasma

SalivaWhole blood

Sputum

PBMCCulture isolate

Serum

Legend

Aliquots distributed

2020

Fever

Malaria

11

Requesters

Requesters

Urine PlasmaSalivaWhole blood

Legend

0 50 100 150 200 250 300

San Raffaele

LSTM

A. Mayor Laboratory

NMI

Cepheid USA

DCN Diagnostics

Duke University

20

90

100

100 200

20

20

45

[300]

0 50 100 150 200 250 300

LSHTM

Bionote, INC.

Arista Biologicals Inc

Shenzen Bioeasy Biotechnology Co., Ltd

INTEC PRODUCTS, Inc

MICROSYNTH

Purdue University

A. Mayor Laboratory

Wyss Institute of Harvard University

80

25

81 80

8

60

6

35 25 40

30

250

[100]

[241]

82

Aliquots distributed

Aliquots distributed

TB

12

0 200 400 600 800 1000 1200 1400 1600 1800 2000

Cepheid AB

InBios International Inc.

UCSF/Gladstone

CSU

Clemedi AG

Cepheid USA

KEI

Meso Scale Diagnostics

Scanogen Inc.

Washington UniversitySchool of Medicine

RIT/JATA

PATH

LSI Medience Corporation

Wyss Institute of Harvard University

Stellenbosch University

LUMC

DCN Diagnostics

FIND

San Raffaele

Biotem 1799 46 [1845]

150 333

300

480

100175

800

320

560

[483]

[275]

480

175

6

80

60

60

30

83

6060

139

2020

8181 [162]

[120]

[40]

167

Urine Plasma

SalivaWhole blood

Sputum

PBMCCulture isolate

Serum

Legend

Requesters

HCV

14 [1231]

0 200 400 600 800 1000 1200 1400 1600 1800 2000

Molbio DiagnosticsPvt. Ltd. Karnataka

DCN Diagnostics 1217

76 5 [81]

Requesters

Aliquots distributed

Aliquots distributed

Campus Biotech,Chemin de Mines 9,

1202 Geneva - SwitzerlandT: +41 (0)22 710 05 90 – F: +41 (0)22 710 05 99

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