Subject: Re: Request for NO Objection for purchasing test systems
From: Tamar Gabunia <[email-masked]>
To: Volkan Cetinkaya <[email-masked]>, Maddalena Honorati <[email-masked]>, Tanvir Hossain <[email-masked]>, Nino Ramishvili <[email-masked]>, Mehek Marwaha <[email-masked]>, Giacomo Ottolini <[email-masked]>, Benedetta Magnaghi <[email-masked]>, Tamar Tsenteradze <[email-masked]>, Iryna Postolovska <[email-masked]>
Cc: Maia Nikoleishvili <[email-masked]>, Beka Jakeli <[email-masked]>, Tinatin Khardziani <[email-masked]>
Date: Tue, 16 Jun 2020 18:00:30 +0000

​Many thanks!

From: Volkan Cetinkaya <[email-masked]>

Sent: Tuesday, June 16, 2020 6:30 PM

To: Tamar Gabunia; Maddalena Honorati; Tanvir Hossain; Nino Ramishvili; 'Mehek Marwaha'; Giacomo Ottolini; 'Benedetta Magnaghi'; Tamar Tsenteradze; Iryna Postolovska

Cc: Maia Nikoleishvili; Beka Jakeli; Tinatin Khardziani

Subject: RE: Request for NO Objection for purchasing test systems

Dear Tamar,

Based on the information provided, the Bank has no objection to this procurement.

Best,

Volkan

From: Tamar Gabunia <[email-masked]>

Sent: Tuesday, June 16, 2020 5:41 AM

To: Volkan Cetinkaya <[email-masked]>; Maddalena Honorati <[email-masked]>; Tanvir Hossain <[email-masked]>; Nino Ramishvili <[email-masked]>; 'Mehek Marwaha' <[email-masked]>; Giacomo Ottolini <[email-masked]>;
'Benedetta Magnaghi' <[email-masked]>; Tamar Tsenteradze <[email-masked]>; Iryna Postolovska <[email-masked]>

Cc: Maia Nikoleishvili <[email-masked]>; Beka Jakeli <[email-masked]>; Tinatin Khardziani <[email-masked]>

Subject: RE: Request for NO Objection for purchasing test systems

[External]

Dear Volkan

Many thanks for your reply and no objection on selected items. In regard to your request for additional information in connection with the purchase of PCR tests listed below:

250,000 units of PCR tests manufactured by
ThermoFisher;

Sansure Biotech PCR
Tests -
55 200
units;

250 units of extraction kit for
62 500
Samples manufactured by
Qiagen.

We would like to inform you about the variety and number of devices available in Georgia, which are used for the diagnosis of nCOVID-19 virus. At this stage, 18 laboratories are
involved in this process, and whereas 24 laboratories will perform coronavirus PCR diagnostics from July on.

The table below describes the models, manufacturers and the capacity of the PCR diagnostic equipment available to Georgia:

PCR equipment

Manufacturer

Quantity

Daily Testing capacity / per instrument

Quant Studio 5 Real-Time PCR System

Thermo Fisher Scientific

10

4*96 or

2*384

7500 Fast Real Time PCR system

Thermo Fisher Scientific

10

3*96

BioRad iQ5 real-time PCR detection system

BioRad

7

4*96

m2000 RealTime System

Abbott

2

2*96

LightCycler® 480II Instrument

Roche

1

3*96

QX200 ™ Droplet Digital ™ PCR System

Bio-Rad

1

1*384 or

1*96

Rotor-Gene 6  chanel

Qiagen

2

3*72

Rotor-Gene 5  chanel

Qiagen

1

3*72

Rotor-Gene 2  chanel

Qiagen

4

3*72

Quant Studio 7 Real-Time PCR System

Thermo Fisher Scientific

1

4*96

Procleix Panther System

Grifols

2

2*250

In the selection of PCR tests the capacity and the relevant validated protocols were taken into account. Here is a comparison of the prices of different PCR tests.
Below please find a price comparison of various PCR tests. In addition, we would like to highlight that, although all the listed tests have been used once by our laboratories,
ThermoFisher and Sansure tests stand out with high sensitivity. Korean product -Solgen has also had satisfactory performance.
Roche tests only have a valid protocol on the Roche apparatus, while the rest are less sensitive. Here we compare the prices of various PCR tests and extraction kits by unit testing.

Test name

Manufacturer

Price per test (GEL)

Type

Novel Coronavirus(2019- nCoV) RT-PCR Detection Kit (#24)

Sansure Biotech Inc, China

48

PCR test

TaqPath™ COVID-19 CE-IVD RT-PCR Kit, Applied Biosystems™

Thermo Fisher Scientific, USA

56

PCR test

Modular Wuhan COV E-gene LightCycler Multiplex RNA Virus Master Mix

Roche

29

PCR test

Logix Smart Coronavirus Disease 2019 (COVID-19) kit Logix Smart

Co-diagnostics Inc,  USA

29

PCR test

DiaPlexQ Novel Coronavirus Detection kit

Solgent, Korea

60

PCR test

Genefinder Covid 19 plus Realamp kit

Genefinder, Korea

30

PCR test

QIAamp Viral RNA Mini

Qiagen, Germany

17

Manual Extraction

MagMAX ™ Viral/pathogen II (MVP II Nucleic Acid Isolation Kit 2000 preps)

Thermo Fisher Scientific, USA

5.6

Extraction

(for automotive

extractor)

EURx GeneMATRIX VIRAL RNA/DNA Purification kit

Roboklon, EURx Germany

7.5

Extraction

As for the extraction kits,
there are an automatic extraction
as well as
manual consumption. Automatic extraction machine is a closed system and we are limited in the selection process, however, there are only 8 machines in Georgia
and therefore both types of extraction are required. Qiagen production
kits have been selected for manual extraction, these products are available
in Georgia, they have
local dealers and we have a long experience of relations. Alternatively,
we bought kits from China (Fosun) for the extraction of 40,000 extracts, but it did not come with the additional test tubes needed for the procedure, which
became
difficult to purchase, and we cannot use these kits extensively.

Should you have additional questions please kindly let me know.

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia,
MD, MPH

First Deputy Minister

From: Volkan Cetinkaya [mailto:[email-masked]]

Sent: 12 June, 2020 04:30

To: Tamar Gabunia <[email-masked]>; Maddalena Honorati <[email-masked]>; Tanvir Hossain <[email-masked]>;
Nino Ramishvili <[email-masked]>; 'Mehek Marwaha' <[email-masked]>; Giacomo Ottolini <[email-masked]>;
'Benedetta Magnaghi' <[email-masked]>; Tamar Tsenteradze <[email-masked]>; Iryna Postolovska <[email-masked]>

Cc: Maia Nikoleishvili <[email-masked]>; Beka Jakeli <[email-masked]>; Tinatin Khardziani <[email-masked]>

Subject: RE: Request for NO Objection for purchasing test systems

Dear Tamar,

Based on the information you provided, the World Bank has no objection to your proposal as follows:

Amend the contract #COVID19/G/DC-01 for the additional 67,000 units of rapid test kits.

Direct contracting for Antigen Rapid Test Kits from SD Biosensor.

At present, World Bank is reviewing your request to follow direct contracting method for the PCR testing kits. In order for us to complete our review could you please provide following information:

Ø
We understand Georgia is doing COVID-19 test only in Thermo PCRs; please confirm.

Ø
Existing capacity of Thermo PCRs; meaning the maximum number of testing capacity per day for COVID-19.

Ø
Price comparison of PCR testing kits with similar brands.

Thanks in advance!

Best,

Volkan

From: Tamar Gabunia <[email-masked]>

Sent: Wednesday, June 10, 2020 1:18 PM

To: Volkan Cetinkaya <[email-masked]>; Maddalena Honorati <[email-masked]>; Tanvir Hossain <[email-masked]>;
Nino Ramishvili <[email-masked]>; 'Mehek Marwaha' <[email-masked]>; Giacomo Ottolini <[email-masked]>;
'Benedetta Magnaghi' <[email-masked]>; Tamar Tsenteradze <[email-masked]>; Iryna Postolovska <[email-masked]>

Cc: Maia Nikoleishvili <[email-masked]>; Beka Jakeli <[email-masked]>; Tinatin Khardziani <[email-masked]>

Subject: Request for NO Objection for purchasing test systems

Importance: High

[External]

Dear Volkan,

This is to bring to your attention to the possible stock out of the PCR and Rapid testing kits of nCOVID-19.

Following reopening and resuming economic operation of the country, the higher need of the test consumption is envisaged. Average daily consumption as of May are presented below:

PCR testing - As of June 4, 2020 the number of PCR testing conducted from January 30th is 67,394, out of which 46,011 was utilized in May. Average daily usage is 1,500 testing (the average daily usage including
control tests is approximately 1800-2000). Testing will be gradually increased, since the mandatory testing becomes more intensive in risk groups, pre-trial studies are also planned in different regions and the list of groups which are undergoing mandatory
testing according to the Order №01-190/o of the Minister dated 7 May will be increased as well. It will initially reach 3,000 daily testing (100,000 tests per month), which may later increase dramatically with the opening of borders and the full development
of the economy. Consequently, the country must have at least 100-150,000 test stock at the beginning of each month.

Rapid testing - As of June 4, 2020 the number of Antibody-based testing conducted in the country is 3,521 and the number of antigen-based tests - 411. According to the data of May, the daily usage of Antibody-based
tests is 45-55, and antigen-based tests - about 20. An increase of the usage of the rapid tests will depend on the epidemiological situation and amendment to the protocol that is currently focused on utilizing PCR tests. According to the order №01-144/ო of
the Minister dated April 1, 2020, the use of antigen-antibody testing is planned in various focus groups, in particular, in pregnant women (routinely), before surgical interventions, in patients with other non-fever somatic diseases, as well as in areas affected
by serological studies etc.  Consequently, the usage of the rapid testing is planned to increase to 1000-1500 per day.

Available stock for the testing kits:

PCR        64,896

PCR Extracting kit 54,232

Antibody 29,254

Antigen 34,055

In order to meet the increased demand for testing, it is necessary to fill up the inventory at least for the following two months.  For this purpose, intensive local market survey has been conducted.

PCR - As demand has increased dramatically, there has been a shortage of quality reagents in the world market. Therefore, the selection of supplier was based on a flexible supply scheme taking into account the
quality and price of the reagents. An important factor in this process is the existing material and technical resources, platforms of PJR and interactive machines. For some of the testing machines are closed systems, meaning, the reagents can be provided by
the manufacturer solely, such as Roche, Abbott, Grifols, Thermo, etc. For acquisition of the reagents of closed testing platforms, we have approached to local dealers of these manufacturers and requested the quotes and delivery schedule. The quotes with the
schedule are attached to this email.

As for the open testing systems, a list of tests recommended by WHO was used during the selection, as well as a list of diagnostic kits provided by the Global Fund. Also, in the selection, preference was given
to kits already validated and used in Georgia, in particular by the Lugar Center, as the laboratories involved in the diagnostic network nCovid-19 underwent appropriate trainings and were given recommendations (Qiagen, Roboklon, Altona, Sansure, Thermo).

Rapid tests – the approach highlighted above was applied to the local rapid test market as well. In rapid test case, the acquisition of large inventory is not recommended. As situation evolves, so does the quality
of the rapid tests. New and improved tests are being registered time after time. Therefore, purchase of more than 50,000 per month is not recommended.

The preference in the selection of rapid test providers was given to the flexible delivery schedule and validated products. In this process, the supplier was identified which already provided the rapid testing
kits under COVID-19 project financed by World Bank, which can immediately supply 17,000 units of tests immediately and additional 50,000 units within 2 weeks after the order. These tests have been positively evaluated and validated by the laboratories of Georgia.
The results of the laboratory tests and references are attached.

As for the antigen rapid test kits, as you know, there are very few suppliers in the world, out of which fewer are certified and recommended by WHO. In this light, we would like to approach supplier of already
validated test kits by the laboratories of Georgia and accredited by WHO. Previously ordered tests by national laboratories were highly satisfactory and recommended. Procurement of 50,000 AG testing kits are planned with the price of US$ 12 per unit (FOB).

In the light above, we kindly request your No Objection to:

1.            Direct contracting for the PCR testing kits as per attached schedule and price;

2.            Amend the contract #COVID19/G/DC-01 for the additional 67,000 units of rapid test kits.

3.            Direct contracting for Antigen Rapid Test Kits from SD Biosensor.

Kind regards,

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia,
MD, MPH

First Deputy Minister