kalau kita ada lab rnd yang bagus di malaysia, malaysian scientists patut cipta / innovate covid19 test kits sndiri seperti korea selatan. so that x payah lah import dari luar... then boleh check kat semua warganegara malaysia... tapi itulah, myb pandemic kalini dapat ditangani dan memberi 1 pelajaran baru buat malaysia. utk sediakan mcm2 fasiliti di malaysia.
MyEG's Covid-19 rapid test kit approved by US FDA
KUALA LUMPUR (March 23): My EG Services Bhd (MyEG) said its Covid-19 rapid test kit has been qualified for emergency use by the US Food and Drug Administration (FDA), paving the way for the sale of the kits in the US, where the number of positive cases has surpassed 33,000, with 417 deaths.
In Malaysia, the rapid test kit is pending approval and certification by the Ministry of Health (MoH). The company had earlier said the kit has already been approved by health authorities in China and Europe, where they are already being used widely.
MyEG said the test kit, developed by an unnamed "reputable" Chinese biomedical company, has been approved by the FDA under a policy to accelerate detection and diagnosis during public health emergencies.
"The authorisation by the FDA for the test kits is in addition to the European CE mark, which certifies conformity with health, safety, and environmental protection standards, obtained earlier," it said in a statement today.
"The acceptance of the test kits worldwide, including in major regions like the US and Europe, is timely amid growing acknowledgement worldwide of the need for faster and more widespread detection capacities in the fight to contain the spread of the virus," MyEG added.
The company said the test kit enables early detection of the Covid-19 virus by detecting the presence of antibodies from blood samples which are taken through finger-pricking.
MyEG claimed that the kit can generate results on the spot within minutes, without having to send the samples to external diagnostic laboratories.
Presently, the test kits are available for pre-order on MyEG’s website at a price of RM99 per unit in a set of 10 units while stocks last.
"An upgraded kit with testing for additional antibody has been introduced at RM149 per unit and also available in sets of 10 units per pack," it added.
Last Friday, the MoH retracted its Facebook post which alleged that MyEG’s RM99 Covid-19 rapid testing kit is fake news.
The social media posting had raised questions about the reliability of the testing kit, which claims to produce results in just 30 minutes, but MyEG had insisted that its product is not fake.
The company clarified that its Covid-19 rapid test kits exist, and are currently awaiting approval from the local authorities and certification from the MoH.
At 3.54pm, MyEG fell three sen or 3.59% to 80.5 sen, with 37.86 million shares traded. The company was valued at RM2.77 billion.
#dudukrumahdiamdiam and get the news at theedgemarkets.com.
See also: MyEG says Covid-19 test kits not fake but pending MoH approval
MyEG says Covid-19 test kits not fake but pending MoH approval
KUALA LUMPUR: MyEG Services Bhd has clarified that its Covid-19 rapid test kits do exist, and is currently awaiting approval from the local authorities and certification from the ministry of health (MoH).
In fact, MyEG said the rapid test kits have been cleared by health authorities in China and Europe, where they are already being widely used.
“Due to the simplicity of use for the testing kit, MyEG believes that it is an accessible option to increase testing among Malaysians to help assist in early detection and further prevent the spread of the virus. It will also help give Malaysians some peace of mind given its relative ease of use,” it said in a statement yesterday.
MyEG was referring to a social media post by the MoH declaring that the Covid-19 rapid test kit was fake. The test kit was featured on MyEG’s official website, offered at RM99 per kit, or RM990 for a set of 10.
MyEG said the testing kit is an accessible option to help Malaysians in early detection of the Covid-19 virus.
The government’s e-services platform explained that due to the pandemic emergency, most countries accept the declaration of conformity, with clinical trial reports and all relevant supporting documents.
As such, MyEG said it is working in parallel to accept pre-orders in order to secure availability from its partner, an undisclosed Chinese biomedical firm, to ensure sufficient supplies once certification is received.
MyEG assured that pre-order payments are fully refundable if for any reason certification is not received.
MyEG shares closed 5.5 sen or 6.01% lower at 86 sen yesterday after 46.4 million shares were done, giving the group a market capitalisation of RM2.98 billion.
PUTRAJAYA: Penggunaan teknik Rapit Test Kit (RTK) atau kit ujian pantas tidak disarankan untuk tujuan diagnosa COVID-19, sebaliknya keputusan ujian tepat melalui teknik Real-Time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR), yang dijalankan Kementerian Kesihatan Malaysia (KKM) adalah penting dalam pengurusan pesakit COVID-19 yang berkesan.
Ini berikutan, teknik ujian rRT-PCR mampu mengesan virus yang masih berada dalam badan pesakit.
Ketua Pengarah Kesihatan, Datuk Dr Noor Hisham Abdullah, berkata melalui teknik kit ujian pantas yang kini terdapat di pasaran pula, ia bertujuan mengesan antibodi yang terhasil di dalam badan akibat jangkitan yang dialami.
Beliau berkata, antibodi muncul di dalam badan antara lima hingga lapan hari selepas jangkitan.
Katanya, teknik rRT-PCR digunakan untuk ujian makmal yang dijalankan di makmal fasiliti kesihatan kerajaan bagi mengesan jangkitan COVID-19.
"Ujian rRT-PCR yang dijalankan akan mengesan kehadiran virus COVID-19 yang terdapat di dalam badan pesakit. Justeru, ujian rRT-PCR COVID-19 yang positif bermaksud individu itu telah dijangkiti oleh virus COVID-19".
"Ujian RTK yang mengesan antibodi, tidak dapat mengesan virus dan membuat pengesahan pantas jangkitan".
"Ini menyebabkan ia tidak dapat membantu dalam pengesanan awal kes COVID-19," katanya pada sidang media harian di KKM, di sini, hari ini.
Justeru, Dr Noor Hisham berkata, KKM menggesa orang ramai untuk tidak menjalani ujian RTK dengan sewenang- wenangnya tanpa mendapat khidmat nasihat daripada pengamal perubatan, kerana ia berpotensi untuk menimbulkan salah tafsir dan keresahan terhadap keputusan ujian yang diperolehi.
Post time 23-3-2020 12:37 PM
Post time 24-3-2020 07:00 PM
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