Influenza Test Kit for Flu A, Flu B & COVID-19

No. Do not use the test device if the pouch is damaged or the seal is broken/ incomplete. Please use a new test.

No. Desiccant should come together with test device in the pouch. Please use a new test.

No. User should not use the test beyond the expiry date shown on the test kit labelling.

No. Only use fresh direct anterior nasal swab specimen from patient.

It is recommended to use only direct anterior nasal swab specimen from patient. Do not use other types of samples and please follow the IFU strictly.

No. Buffer from other brand cannot be used as a substitute for the buffer in this kit. Please contact your supplier for assistance.

The buffer provided in the kit are more than the actual volume needed to run a single test. User should check the IFU again and ensure that the tests are run following the correct assay procedure.

Sometimes, samples from the patient can be thick and viscous. This may reduce the mixing efficiency of buffer with sample and cause flow impairment on the test strip, leading to possible inaccurate or invalid results. Therefore, it is advisable to avoid overly-thick mucus and re-collect new sample if necessary. If a viscous sample cannot be avoided, please mix it thoroughly in the buffer and try not to force the thick material through the dropper.

It may be due to insufficient specimen or buffer volume. Sufficient amount of specimen and buffer are important to ensure the sample to flow up properly. Please repeat the test with a new test device if invalid results observed.

When adding buffer, it is important to hold the buffer tube vertically, carefully press the tube to release full drop of buffer, one drop by one drop. The droplet volume of the buffer may be inconsistent if the buffer tube is not held vertically above the well “S”, or buffer being released
too fast.

No. The assay procedures need to be followed strictly. If no sample flow observed, check again the procedure and repeat the test with a new test device.

Results can be read from 10-20 minutes. Positive results may be visible as quick as 3 minutes. Negative result must be confirmed at 20 minutes.

No. Do not read results after 30 minutes. Results read after 30 minutes may lead to a false positive, false negative, or invalid result.

If coloured bands appear at the control line (C) and test lines (CV19, B, and/or A), it indicates a positive result. Positive results indicate the presence of Influenza A, Influenza B and/or SARS-CoV-2 antigen in the specimen. Positive result should not be used as the sole criteria for the diagnosis of Influenza A, Influenza B and/or SARS-CoV-2 viral infection. Positives results should be confirmed by alternative testing method and clinical finding before positive determination is made.

The result is negative if only control line (C) is visible with no coloured line developed at positions CV19, A or B. This indicates that Influenza A, Influenza B and/or SARS-CoV-2 antigen has not been detected. Negative result does not preclude the possibility of exposure to or infection, particularly in the presence of clinical signs and symptoms consistent with influenza or COVID-19.

If the symptom persists, while the result is negative or non-reactive result, it is recommended to re-sample the patient few days later or test with an alternative testing method such as PCR.

Place the used test device and buffer tube into the biohazard waste bag provided and seal the zipper completely. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens and test devices.

Users should follow respective Good Laboratory Practice SOP of the labs. However, it is recommended to use external controls, positive and negative, to confirm the test procedure and to verify proper test performance, particularly under the following circumstances:

• New operator uses the kit, prior to performing testing of specimens.
• A new lot of test kits is used.
• A new shipment of test kits is used.
• The temperature used during storage of the kit falls outside of 4-30°C.
• The temperature used during storage of the kit falls outside of 2-30°C.
• To verify a higher-than-expected frequency of positive or negative results.
• To investigate the cause of repeated invalid results.

The RESZON® ABC Combo Test is a professional in vitro diagnostic test for trained healthcare professionals in clinical settings, which include clinics, hospitals, clinical diagnostic laboratories, and health screening companies. It is not intended for home or self-testing. MDA Malaysia has not approved any influenza rapid test kit for consumer self-test use. Local distributors with MDA Establishment License and GDPMD certification intended to distribute to medical professionals may also enquire with Reszon directly.

Yes. The RESZON® ABC Combo Test holds MDA registration number IVDC5790924-181335 under Malaysia’s Medical Device Act 737. This confirms the product meets regulatory requirements for professional in vitro diagnostic use in Malaysian clinical and laboratory settings.

Yes. Reszon Diagnostics supplies the RESZON® ABC Combo Test directly to clinics, hospitals, health screening medical centre, clinical diagnostic lab, and medical device distributors in Malaysia and internationally. Contact Reszon via WhatsApp (+6012 815 8689), phone (+603 8022 1162), or email (info@reszonics.com) to discuss order quantities and pricing.

Procurement teams should prepare the following details before requesting a quote for influenza rapid test kits:

1. Confirm the intended use setting: Clinic, hospital, health screening programme, or medical device distribution, as this is associated with medical device regulatory compliance.
2. Estimate monthly or annual volume: Since pricing is typically tiered by order quantity.
3. Verify the supplier holds an MDA Establishment License as a distributor and the product holds an active MDA Registration Number. RESZON ABC Combo Test is registered under IVDC5790924-181335.
4. Confirm the receiving facility’s storage conditions: Kits are required to be stored at 2–30°C.

Having these ready reduces back-and-forth before an order is confirmed.

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