DOH - Covid-19 Rapid Antigen Test

Technical Specifications
Republic of the Philippines

Department of Health
TECHNICAL SPECIFICATIONS
Quantity
Item No. 1 Covid-19 Rapid Antigen Test 20,264,800 tests
/ Unit
Name of Manufacturer: Country of Origin:
Brand:
Total ABC: PhP668,738,400.00
MAXIMUM PURCHASER’S SPECIFICATION STATEMENT OF
ITEM
QUANTITY COMPLIANCE
Covid-19 20,264,800 A. Detailed Technical
Rapid tests Specifications:
Antigen Test
1. Principle: In vitro Rapid
Chromatographic
Immunoassay for the
detection of SARS-COV-2
Antigen
2. Specimen Type:
Nasopharyngeal and/or
Oropharyngeal Swab
3. Test Kit Package Content:

One (1) test kit is
equivalent to 1 test and
should contain all
materials and accessories
necessary for the
procedure:
a) 1 pc swab
(nasopharyngeal or
oropharyngeal)
b) 1 test kit cartridge
c) 1 tube or equivalent
container for mixing
of buffer with
sample, buffer, or
equivalent (either in
one bottle per
certain number of
test kits or already
pre-installed in each
tube)
d) 1 dropper or
equivalent sample
delivery instrument
as provided in the
38
Quantity
/ Unit
Brand:
Total ABC: PhP668,738,400.00
Instructions for Use
(IFU)
4. Storage Temperature: 18-30

°C
5. Result must be read visually

without the need for any
reader/equipment/machine
6. Biosafety Concerns: Can be

done without the need for
Biosafety Level (BSL) 2 or
3 Facilities
7. Clinical Sensitivity and

Specificity based on third-
party evaluation: At least
80% sensitivity (A useful
assessment of the test’s
performance is to consider
sensitivity among patients
whose positive samples
exhibit RT-PCR cycle
threshold of less than 30)
and at least 97% specificity
based on the third-party
evaluation such as RITM,
WHO FIND, or WHO
Emergency Use Listing
(EUL)
8. Processing time: Less than

30 minutes from sample
inoculation to reading of
result. Result output is rapid
and qualitative.
9. Reference Standard: WHO

Target Product Profiles for
Rapid Antigen Test; must
adhere to specifications,
stipulated in HTAC
39
Quantity
/ Unit
Brand:
Total ABC: PhP668,738,400.00
Guidance Documents for
Rapid Antigen Test
B. Additional Requirements in Technical Specifications form, arranged, numbered, and

tabbed as enumerated below:
1. Certificate of Authorization from the Food and Drug Administration (FDA) Philippines;
2. Valid and current License to Operate (LTO) as medical device importer, wholesaler,
suppliers, distributors or traders issued by the Philippine FDA.
Note: Existing Licenses to Operate (LTO) and Certificates of Product

Registration/Notification (CPR/Ns), and other existing authorizations issued by the
Food and Drug Administration (FDA) that have a validity expiring on 01 January
2022 to 31 December 2022, are automatically extended. An additional four (4)
months validity from the original date of expiration of the market authorization
shall be given; provided, that a complete application for renewal of the said
authorizations have been filed with the FDA within the given extension period [FDA
Circular No. 2021-025-A]
3. The bidder shall submit any of the following whichever is applicable:

a) If the bidder is a manufacturer, certificate that the bidder manufactures the
products/item; or
b) If the bidder is an Exclusive/Authorized Distributor or Dealer of the products/items, a
Certificate or Contract from the manufacturer must be provided as proof that the bidder
is an Exclusive/Authorized Distributor or Dealer of the products/items; or
c) If the bidder is an agent of the exclusive distributor or dealer, the following must be
provided:
i. Certificate or Distributor/Dealership Agreement by the Manufacturer with the
distributor or dealer; and
ii. Certificate or Contract/Dealership Agreement between the distributor/dealer
and the bidder.
4. Valid and Current Declaration of Conformity with appropriate ISO/IEC/PNS standard

issued to the manufacturer by an ISO Certifying body or any appropriate agency or body;
5. Product Insert/Product Information/Original Brochure or downloaded from the internet and

other manufacturer’s un-amended sales literature, unconditional statements of specification
and compliance issued by the manufacturer, samples, independent test data etc., as
appropriate for cross-referencing statement of compliance to the technical specification in
accordance to what is indicated in 2nd page of Section VII. Technical Specifications of the
Bidding Documents;
6. Screenshot from the Research Institute for Tropical Medicine (RITM) website showing that
40
Quantity
/ Unit
Brand:
Total ABC: PhP668,738,400.00
the kit is evaluated or recommended by the RITM if with External Validation Result;
7. Unconditional notarized letter of guarantee letter from supplier for item replacement within
three (3) months before expiration, in case the delivered kits are below the required 18-24
months shelf-life
8. Sworn Statement using the prescribed form.
Note:
Except for ISO Certificates with an affixed working QR Code, all documents issued abroad
should have a red ribbon certificate from the Philippine Consulate/Embassy or an Apostille
issued by a competent body authorized under the Apostille Convention.
If the red ribbon or Apostille is not available during the Submission of Bids, the bidder may
submit instead a copy of the Official Receipt from the Consulate or Apostille issuing body
proving that the subject document is undergoing authentication.
C. Upon delivery the following shall be complied with:
1. Shelf life:
a) Must be freshly manufactured stock with a total shelf life of at least 18-24 months
from the date of delivery; Below 18 months can issue guarantee letter subject for
approval.
b) Supplies with a shelf life of less than 12 months on the date of delivery will not be
accepted.
2. Packaging instructions:
a) Primary packaging: Standard manufacturer’s packaging.
b) Secondary packaging: Should strictly follow the manufacturer’s recommended
instructions in the packaging and should follow the manufacturer’s temperature
requirement for packaging while on shipping and on storage with continuous
monitoring and documentation.
3. Labeling instructions:
a) On each box, the following should be legibly imprinted or stickered with a non-removable
or permanent sticker or label that is binding and with residue and tearing, if removed:
Philippine Government Property – Department of Health
NOT FOR SALE
Date of Manufacture: ____________________

41
Quantity
/ Unit
Brand:
Total ABC: PhP668,738,400.00
Date of Expiry: _________________________
Batch/Lot No.: _________________________
b) On each corrugated carton, the following should be legibly imprinted or stickered with a
non-removable or permanent sticker or label that is binding and with residue and tearing,
if removed:
Philippine Government Property – Department of Health

NOT FOR SALE
Date of Manufacture: ____________________

Date of Expiry: _________________________
Batch/Lot No.: _________________________
D. Recall and Replacement:
1. The Supplier must ensure the quality of products and if there will be problems in the
quality, the Supplier will recall and replace the products distributed in the
regions/hospitals/treatment hubs/RHU/HC/BHSS based on Guidelines on Product Recall,
FDA Circular No. 2016-012;
2. In instances of product recalls due to failures of suppliers and manufacturers to comply with
standards of safety and quality, the cost associated with proper disposal/ destruction,
handling or pull out from health facilities where these products have already been
distributed shall be borne by the supplier (subject to the latest policy for disposal) (DOH
Administrative Order(AO) No. 2019-0041);
3. If the item is with approved shorter shelf life, the replacement for fresh stocks shall be
issued when returned three (3) months before the expiry date. The supplier shall be liable
for all the recall and replacement costs including reverse logistics of all supplies that have
already been distributed to the facilities
______________________
Signature over Printed Name
[date of signing]
In the capacity of: [title or other appropriate designation]
Duly authorized to sign bid for and on behalf of: [Name of Company]
[Complete office address]
[Contact No.]
[Fax No.]
[Email Address]
42

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Technical Specifications

Republic of the Philippines

3. Test Kit Package Content:

4. Storage Temperature: 18-30

5. Result must be read visually

6. Biosafety Concerns: Can be

7. Clinical Sensitivity and

8. Processing time: Less than

9. Reference Standard: WHO

B. Additional Requirements in Technical Specifications form, arranged, numbered, and

Note: Existing Licenses to Operate (LTO) and Certificates of Product

3. The bidder shall submit any of the following whichever is applicable:

4. Valid and Current Declaration of Conformity with appropriate ISO/IEC/PNS standard

5. Product Insert/Product Information/Original Brochure or downloaded from the internet and

8. Sworn Statement using the prescribed form.

C. Upon delivery the following shall be complied with:

Date of Manufacture: ____________________

Philippine Government Property – Department of Health

Date of Manufacture: ____________________

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