The brand name of the endorsed kit does not match the brand name indicated on the technical document. Will RITM accept such documents?
RITM may accept such documents provided that a Certificate of Equivalency is issued by the manufacturer as part of the documentary requirements.
When applying for self-test rapid antigen kit, will RITM accept independent studies and other technical documents that utilize NPS OPS as samples (professional use)?
RITM may accept independent studies using rapid antigen kits for professional use provided that the raw materials are the same as in the self-test kits. The supplier must provide a Certificate of Equivalency issued by the manufacturer.
Can the manufacturer’s validation report be considered the same as an independent study?
No. The manufacturer’s validation report is a technical document supporting the manufacturer’s claim showing the sensitivity and specificity of both clinical and analytical performance. On the other hand, an independent study is a third-party performance evaluation conducted by reputable Institutions or other National Regulatory Agencies. Alternatively, scientific publications in peer-reviewed, non-predatory journals are also accepted. The list of supporting independent studies is available on the RITM website.
What is the FLEX study and is it different from a usability study?
Flex studies evaluate the robustness of an assay done with the device in its final design/format and should be performed by competent technicians. Temperature and humidity, reading period, and sample amount are minimum prerequisites for Flex study design. The report should be published or signed by a principal investigator stating the affiliation and date of evaluation.
A usability study is performed to evaluate the ability of laypersons to perform the entire workflow of the procedure following the instruction for use. RITM encourages suppliers to submit their usability protocols including questions for study participants with pre-defined acceptance criteria and a defined strategy to mitigate risk errors identified in the study such as protocol modification. Enrollment population should represent different socioeconomic and educational backgrounds.
What PCR test kit qualifies for a performance evaluation?
1. PCR or NAAT test kits that are not yet evaluated by RITM.
2. Previously RITM-validated test kits that have undergone modifications in the assay component/s, assay profile or any part of the procedure that can affect the assay performance.
What third-party or independent performance evaluation will be honored in lieu of a full evaluation in RITM?
Performance evaluation reports that are published publicly and done by other institutions, other National Regulatory Agencies (NRA), or international regulatory agencies that include but not limited to World Health Organization (WHO), Foundation for Innovative Diagnostics (FIND), US CDC, US FDA, TGA Australia, MHRA UK, Singapore Regulatory Agency, and others that may fall under the following criteria:
– Academic institutions
– Non-profit organizations
– Government hospitals or medical institutions
– No for-profit or privately funded organization or institution
What is the turn around time for a full PCR kit evaluation?
Product evaluation will take at least twenty (20) working days upon receipt of ALL mandatory requirements: complete submission of documentary requirements, payment of evaluation fees, complete submission of the required number of product samples, and other machine/materials deemed applicable, and product samples delivered to RITM passed the lot quality check.
What pathogens are included in the performance evaluation of PCR kits?
For now, only SARS-CoV-2 targets of PCR kits to be subjected to performance evaluation are accommodated.
Given the resource constraints for COVID kit evaluation, how does RITM prioritize products for testing?
There are several laboratory teams conducting validation in RITM depending on the platform and commodity. We adhere to the “first come first served” policy.
If a product is unable to meet the claimed sensitivity and specificity requirements in the course of RITM evaluation, how can the affected company work with RITM to ensure that testing is done as per manufacturer's instructions?
An evaluation report is provided to the suppliers by the FDA where the methods are enumerated. RITM performs the evaluation as per manufacturer’s IFU as the standard operating procedure. The supplier may get in touch with RITM if there are clarifications on the evaluations done.
Why do some product evaluations take longer than others?
For some products, there is a challenge in the supply of samples (fresh swab samples for antigen tests; need for acute and convalescent serum for antibody tests) and it takes time to establish a pool of suitable samples to achieve the minimum sample size needed for RITM’s standard protocol.
Rest assured that RITM is doing its best to serve its clients.
What is the process for evaluation?
Please refer to our website for the guidelines.
Actual validations are based on protocols with reference to US FDA, WHO and FIND procedures.
Will we receive copies of the RITM evaluation report?
After securing endorsement letter from FDA, do we also need to submit hardcopy of documentary requirements to RITM ?
Yes. Please refer to the guidelines for the list of documentary requirements needed to facilitate the evaluation.
Can we deliver the samples in advance or when we submit our application?
No. Please wait for an email instruction regarding delivery of samples. The kit secretariat will inform you on the schedule of delivery.
If two distributors sell the same product, does RITM need to validate the same product twice?
As much as possible, we will synchronize the evaluation to save on time and effort.
For an instrument-based COVID-19 test, how should the company arrange for the testing? Do we need to install instruments at RITM site?
Ideally yes, but given the limited space at RITM , we will coordinate with you on the nearest available installations where RITM can perform the testing independently.
What is the mode of payment for the evaluation fee?
Either cash or check is accepted
Since most of the COVID test kits are still under development and may have future specification changes, how should this be informed to RITM? Will another evaluation be required in case the product has undergone changes after the initial evaluation?
The RITM will appreciate notice of changes to the test kits from the manufacturer or supplier ahead of time. A second evaluation will be conducted as needed.
Kindly coordinate via email at
We have received a letter of disapproval from FDA which means our kit did not meet the minimum performance required. What should we do next?
Secure an endorsement for re-evaluation from the FDA and submit all documentary requirements to RITM. Please see the guidelines for the list of requirements at the RITM website.