LABING anim na rapid test kits para sa coronavirus disease 2019 ang inaprubahan ng Food and Drug Authority.
Sa inilabas na pahayag kanina, sinabi ng FDA na nakompleto ng mga ito ang mga documentary requirements at sumailalim sa review at evaluation ng ahensya.
“As part of FDA’s mandate to ensure safety and quality of these products, surveillance measures are in place to monitor performance and effectiveness.”
Ang mga test kits na ito ay antibodies sa dugo ng indibidwal ang sinusuri. Ang katawan ay gumagawa ng antibodies, partikular ang Total Antibody, IgG antibody at IgM antibody para labanan ang COVID-19.
“Total antibody signifies the collective response of the patient’s immune system. IgM antibodies represent response to a current or recent infection while IgG antibodies represent response from a past infection. Some of the kits detect only one antibody – either IgM or IgG. Some kits detect total antibodies – IgM and IgG together in one result. Other kits detect both IgG and IgM at the same time but give a separate result for each.”
Mahalaga umano na ikonsidera ang kondisyon ng pasyente sa pagkuha ng dugo na gagamitin sa test.
“The selection of the type of kit to be used is also dependent on the indication, the information the doctor wants to obtain, and the specifications of the kit. Interpretation must be done with caution and clinical correlation.”
Paalala ng FDA tanging ang mga health professional ang gumamit ng test kits sa pasyente.
“The agency reiterates that these kits are strictly for medical professional use only and not intended for personal use. The test should be administered by trained health professionals and the results should be interpreted by licensed physicians. Confirmatory PCR based testing is still the gold standard.”
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