Lot Testing QC Report Result Form

Department of Health
Research Institute for Tropical Medicine

Filinvest Corporate City Compound, Alabang, Muntinlupa City, Philippines 1781
Trunk Line Nos.: (63-2) 807-2628 to 32 * Fax Nos. (63-2) 842-2245, 842-2828
Direct Line No.: (63-2) 809-7599 * Website: www.ritm.gov.ph
Malaria RAPID DIAGNOSTIC TEST (RDT)

Quality Control Report
Initial
(Routine)
Report n° RITM-520 Date of the report: 16.08.2012
Report prepared by: name(s) /

QA-RDT network laboratory (Institute): Malaria RDT Quality Assurance Laboratory, Research Institute for Tropical
Medicine
Institution that requested the RDT-QC: name of the institution
name
Place from where tests were sent:
Send address:
Requesting Institution Contact(s): Contact(s) Email:
Interpretation of results: see last page
RDT Product Name: (see product insert) Malaria RDT
Catalog No: 00000

Manufacturer: Company name
Date received: (dd/mm/yyyy) 16-août-12
Place received: RITM, Philippines
Transport method:
(Sending Institution to Testing Institution)
Storage condition during transport:
(Sending Institution to Testing Institution)
Condition of RDTs on receipt:
Kit content: Heat Stability:
Buffer: Lancet : Alcohol swab: Blood transfer device:
Other:
RITM, FCC Cpd., Alabang, Muntinlupa City 1781, Philippines - Tel#807-2628 loc. 227
Controlled document, WHO-FIND malaria RDT evaluation programme, August 2008. mal-rdt@wpro.who.int Page 1 of 5
Lot number(s)
Expiry No of No of Total Testing
Lot no date Boxes tests / to test interval Result Comments
received box
1 08/2015 5 25 125 0 PASS
Summary of results:
Storage % positive results
Product Testing Temp. Date Result Pf Pf Pv Pv Pv Observations
(lot N°) Interval (°C) tested 200 2000 200 500 2000
1 0 Room T°C 16.08.2012 PASS N/A N/A N/A
1. 0 month(s)
Quality control dilutions Lot N°: 1 - RITM

Sample ID (parasites/цl) RDTs Tested RDTs Positive % Positive
Pf X
1. QC testing Method:
RDTs were tested with frozen QC samples based on the algorithm described in SOP 2.06 of the WHO Quality Control
Methods Manual for Malaria RDTs. For a lot of RDTs to pass the QC assessment, all quality control dilutions must be positive
(100%). RDTs which do not meet these criteria will be forwarded to a second laboratory for confirmation. False positive results
will be reported in the 'Observations' section.
The RDT lots will be retained in this laboratory for long term Quality Control. A further report will be issued after the next QC
assessment.
2. Samples used for QC testing

Quality control (QC) samples of dilutions from wild-types parasites prepared according to SOP 3.08 of the WHO Quality
Assurance Methods Manual for Malaria RDTs. Samples are stored at -70oC.
Samples used include:
a) Negative control: 0 parasites/ul of Plasmodium spp.
b) Low Positive Control: 200 parasites/ul of Plasmodium falciparum.
c) High Positive Control: 2000 parasites/ul of Plasmodium falciparum.
d) Low Positive Control: 200 parasites/ul of Plasmodium vivax.
e) Medium Positive Control: 500 parasites/ul of Plasmodium vivax.
f) High Positive Control: 2000 parasites/ul of Plasmodium vivax.
3. RDT preparation method:

RDTs were tested as per manufacturer instructions, using micropipette for blood transfer.
4. Interpretation of results:
For a lot of RDTs to pass the QC assessment, all positive quality control dilutions must be positive (100%).
Performance on Plasmodium negative control samples should also be taken into account when interpreting results.
Interpretation of results:
• PASS: This RDT lot passed the quality control test and the RDT sample assessed detects antigen at a threshold
SUFFICIENT FOR USE in the field.
• DEFERRED: This RDT lot failed this assessment, and has been sent to another institution for confirmation. A final report will
be issued on receipt of the confirmatory results. It is recommended that the lot is RETAINED until a final report is received.
• FAIL: This RDT lot failed the initial QC assessment and also failed confirmatory testing at another institution. It is
recommended that this lot should NOT BE USED in the field as it has been assessed as lacking sufficient sensitivity. It is
recommended that the manufacturer be contacted and advised of the results.
Note:
This RDT lot will be retained for long term Quality Control. A further report will only be issued after the next scheduled
assessment (6 months).
This assessment is performed in collaboration with the World Health Organization (WHO), the Foundation for Innovative New
Diagnostics (FIND) and the Special Programme for Research Training in Tropical Diseases (TDR). The report is prepared for
the confidential information of the institution that submitted these Rapid Diagnostic Tests (RDTs) for assessment. The results
are for use of the institution that submitted the RDTs for assessment as evidence that the stored samples of the particular lot
of RDTs tested performed with sufficient sensitivity for use. They must not be used for purposes of advertising or otherwise
promoting a product, or as evidence of formal approval or recommendation of a product, without the written permission of the
testing institution and World Health Organization. Other than confirmation of sufficient sensitivity of the sample of the tested
lot, the results listed here do not indicate endorsement of the RDT product by the World Health Organization or the testing
institution. While the results indicate that the RDTs tested detect antigen to an acceptable threshold in the QC parasite
samples used for testing, they do not necessarily reflect actual sensitivity in the field where local storage conditions, variation
in parasite antigen, and host factors may affect operation. Recommendations on use and storage of RDTs in the field can be
obtained from the WHO website www.wpro.who.int/rdt, or by email from mal-rdt@wpro.who.int.
Signed :

Lot Testing QC Report Result Form

Uploaded by

Lot Testing QC Report Result Form

Uploaded by

Department of Health

Research Institute for Tropical Medicine

Malaria RAPID DIAGNOSTIC TEST (RDT)

Report n° RITM-520 Date of the report: 16.08.2012

Report prepared by: name(s) /

Interpretation of results: see last page

RDT Product Name: (see product insert) Malaria RDT

Catalog No: 00000

Buffer: Lancet : Alcohol swab: Blood transfer device:

Quality control dilutions Lot N°: 1 - RITM

2. Samples used for QC testing

3. RDT preparation method:

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