Apakah tes virus corona di rumah benar-benar habis masa berlakunya? – Berita Harian Ukiah


Angela Rodriguez |.(TNS) Lebah Sacramento

Meskipun banyak virus pernapasan, termasuk COVID-19, RSV, dan influenza, beredar sepanjang tahun di California, virus-virus tersebut biasanya lebih aktif antara bulan Oktober dan Maret, menurut Departemen Kesehatan Masyarakat California.

Anda mungkin bertanya-tanya apakah gejala pilek yang Anda alami mungkin disebabkan oleh virus corona dan apakah Anda dapat menggunakan tes rumahan lama yang ada di lemari obat Anda.

Apakah Anda masih bisa menggunakan tes COVID-19 di rumah setelah tanggal kedaluwarsanya?

Inilah yang perlu Anda ketahui:

Apakah tes COVID-19 di rumah benar-benar habis masa berlakunya?

Menurut FDA, semua tes diagnostik COVID-19 di rumah memiliki tanggal kedaluwarsa yang tertera pada kotak atau kemasannya.

FDA mengatakan dalam FAQ bulan September tentang pengujian di rumah bahwa tes mandiri seperti itu umumnya tidak boleh digunakan setelah tanggal tersebut.

Namun, periode umur simpan ini dapat diperpanjang seiring tersedianya data stabilitas tambahan.

“Produsen alat tes COVID-19 telah melakukan penelitian untuk menunjukkan berapa lama setelah produksi, alat tes COVID-19 memberikan hasil dengan akurasi yang sama seperti pada hari tes tersebut diproduksi,” kata FDA.

Beberapa kotak alat tes virus corona di rumah
Mulai bulan September, warga California dapat mengajukan permohonan tes COVID-19 gratis di rumah secara online. (Andy Alfaro/Modesto Bee/TNS)

Umur simpan suatu pengujian adalah jangka waktu, terhitung sejak tanggal pembuatan, dimana pengujian tersebut dapat berfungsi sebagaimana mestinya.

Tanggal kedaluwarsa menandai akhir periode tersebut dan menunjukkan tanggal terakhir dimana tes diharapkan memberikan hasil yang akurat.

Bisakah masa berlaku tes virus corona diperpanjang?

Pengujian stabilitas menentukan berapa lama pengujian mempertahankan kinerja yang diharapkan.

FDA mengatakan produsen menyimpan tes untuk umur simpan yang direkomendasikan, ditambah beberapa waktu tambahan untuk memastikan keandalan, dan kemudian mengevaluasi kembali keakuratannya.

Misalnya, jika umur simpan yang diharapkan dari suatu pengujian di rumah adalah 12 bulan, produsen akan menguji keakuratannya setelah 13 bulan penyimpanan untuk memastikan bahwa pengujian tersebut masih berfungsi seperti yang diharapkan.

“Karena produsen alat tes memerlukan waktu untuk melakukan pengujian stabilitas, berdasarkan hasil studi pendahuluan, FDA biasanya mengizinkan tes COVID-19 di rumah dengan masa simpan sekitar empat hingga enam bulan sejak tanggal tes tersebut diproduksi, dan sesuai dengan ketentuan yang berlaku. dapat diperpanjang nanti seiring dengan semakin banyaknya data yang dikumpulkan,” kata FDA.

Setelah produsen pengujian mendapatkan hasil pengujian stabilitas tambahan untuk jangka waktu seperti 12 atau 18 bulan, mereka dapat meminta otorisasi FDA untuk memperpanjang umur simpan.



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