TestNGo COVID-19 Rapid Antigen Saliva Test

SARS-CoV-2 Antigen Test Kit

• Good specificity, suitable for assisting nucleic acid detection for early infection screening.
• High sensitivity, using high-affinity N-protein specific antibodies.
• Colloidal gold method, no additional equipment.
• Rapid test result, get results in 15 minutes.
• Non-invasive sampling, nasopharyngeal swab, nasal swab and saliva are available

Hospital Test Site Airport Station Hotel Corporation Mass Screening

TECHNICAL REPORT

IVD Test Assay Evaluation of TestNGo

COVID-19 Rapid Antigen Saliva Test
Prepared by:

JURAINA ABD JAMIL

Research Officer
WHO Collaborating Centre for Arbovirus Reference & Research (WHOCC: MAA-12)
Tropical Infectious Diseases Research & Education Centre (TIDREC)
Universiti Malaya

DR. TEOH BOON TEONG

Technical Manager
WHO Collaborating Centre for Arbovirus Reference & Research (WHOCC: MAA-12)
Tropical Infectious Diseases Research & Education Centre (TIDREC)
Universiti Malaya

Approved by:

PROFESSOR DR. SAZALY ABU BAKAR

Director
WHO Collaborating Centre for Arbovirus Reference & Research (WHOCC: MAA-12)
Tropical Infectious Diseases Research & Education Centre (TIDREC)
Universiti Malaya
 Material Tested:

TestNGo COVID-19 Rapid Antigen Saliva Test

Manufactured by:

Distributed by:

VQUEST SDN. BHD.

English/ Bahasa Malaysia
EN
TestNGo COVID-19 Rapid Antigen
Saliva Test
SARS-CoV-2 Antigen Test Kit (Self-Test)
INTENDED USE
The SARS-CoV-2 Antigen Test Kit is an
immunochromatographic test system for the rapid,
qualitative detection of SARS-CoV-2 antigen in human
saliva specimens, can be used for diagnosis of
coronavirus infection disease (COVID-19) in vitro, which
is caused by SARS-CoV-2.
This test offers individuals the opportunity for a rapid and
simple self-testing of SARS-CoV-2 virus to take using
simple saliva.
PRINCIPLE
The SARS-CoV-2 Antigen Test Kit is based on colloidal
gold immunochromatography method to detect SARS-
CoV-2 N protein in respiratory secretions and other
specimens. When the specimen is added into the test
device, the specimen is absorbed into the device by
capillary action, mixes with the gold-labeled antibody, and
flows across the precoated membrane.
The SARS-CoV-2 antigen in specimen captured by the
gold-labeled antibody S1a bound to antibody S1
immobilized in the Test Region (T) of the membrane, and
this produces a colored test band that indicates a positive
result.
When there is no SARS-CoV-2 antigen in the specimen
or the concentration is lower than the detection limit of the
test, there is not a visible colored band in the Test Region
(T) of the device. This indicates a negative result.
To serve as a procedure control, a colored line will
appear at the Control Region (C), if the test has been
performed properly.
CONTENTS
1 Instruction for Use 1 Tube with buffer
1 Test Cassette 1 Bags
1 Funnel
MATERIAL REQUIRED BUT NOT PROVIDED
Timer
Personal protective equipment, such a protective
gloves, medical mask, goggles and lab coat.
Appropriate biohazard waste container and disinfectants.
STORAGE CONDITION
Version 1.0
The test card is stable for 12 months (while sealed in an with water upon disposal. INTERPRETATION OF ICONS
aluminum foil bag) if stored at 2～30°C. When the test Avoid having the test solution come into contact with
environment humidity is more than 60%, the test card your eyes, skin and mouth. If contact occurs with the Temperature
Do not re-use
needs to be used immediately after the opening of the eyes, flush with water immediately and seek medical limit
aluminum foil bag. When the test environment humidity is help. If contact occurs with your skin, wash the area In vitro
less than 60%, the test card needs to be used within 1 with soap and rinse with water. diagnostics Batch code
hour after the opening of the aluminum foil bag. medical device
Do not ingest or inhale the test solution. If accidental
LIMITATION OF METHODOLOGY ingestion occurs, please seek medical help
Contains sufficient
Consult
instructions for
immediately.
1. The Novel SARS-CoV-2 Antigen Test Kit is an acute- for test use
DOES THIS TEST HURT?
phase screening test for qualitative detection. Date of
Sample collected may contain antigen concentration The saliva collection won’t cause any discomfort. But Manufacturer
below the reagent’s sensitivity threshold, so a it is important to follow the collection steps as
manufacture
negative test result does not exclude infection with indicated in the procedure.
CE mark Use-by date
novel coronavirus. WHAT DO I DO WITH THE TEST UNIT AFTER
2. The Novel SARS-CoV-2 Antigen Test Kit detects viable READING THE RESULTS?
Keep dry This way up
and non-viable novel coronavirus antigen. Test After recording your results, carefully wrap all product
performance depends on antigen load in the sample
components and dispose by throwing it into the Fragile, handle Stacking layer
and may not correlate with cell culture performed on garbage just like any household trash. Wash your
with care limit
the same sample. A positive test does not rule out hands thoroughly after handling and disposing the
the possibility that other pathogens may be present, Authorized representative in the European
components.
therefore, the results must be compared with all Community
other available clinical and laboratory information to HOW DOES THE TEST WORK?
make an accurate diagnosis. This test is designed to detect the presence of SARS- GENERAL INFORMATION
3. A negative test result may occur if the level of CoV-2 antigens from saliva specimens. Antigens are Shenzhen Ultra-Diagnostics Biotec. Co., Ltd.
extracted antigen in a specimen is below the present on the SARS-CoV-2 virus, and can be used Room 701, No.71-3, Xintian Avenue, Xintian
sensitivity of the test or if poor quality specimen is as markers for disease exposure. Community, Fuhai Street, Baoan District,
obtained. WHAT IF I TESTED NEGATIVE? Shenzhen, P.R.China 518103
4. Performance of the test has not been established for Tel: +86-755-82599902
Rapid antigen tests can only detect the presence of Fax: +86-755-82599221
monitoring antiviral treatment of novel coronavirus. antigens at the time of the test. A false negative result
5. Positive test results do not rule out co-infections with
maybe produced when the level of antigen in the CMC Medical Devices & Drugs S.L.
other pathogens. sample is below the detection limit of the test, the C/ Horacio Lengo N°18, CP 29006, Málaga, Spain
6. Negative test results are not intended to rule in other Tel: +34951214054
sample is collected improperly, or when the test was
coronavirus infection except the SARS-CoV-2. performed incorrectly. If you had contact with a known Mail:info@cmcmedicaldevices.com
7. Children tend to shed virus for longer periods of time or suspected COVID-19 cases, as a best practice, LOCAL AUTHORIZED REPRESENTATIVE
than adults, which may result in differences in performing the test at least once every week is
sensitivity between adults and children List. recommended.
8. A negative result may occur if the concentration of
antigen in a specimen is below the detection limit of HOW ACCURATE IS THE TEST?
the test or if the specimen was collected or The SARS-CoV-2 Antigen Test Kit has been clinically
transported improperly, therefore a negative test validated reach a high detection accuracy, reaching a
result does not eliminate the possibility of SARS- relative detection specificity of 99.33% and a relative
CoV-2 infection, and should be confirmed by viral detection sensitivity of 94.83% in our clinical study.
culture or PCR.
The SARS-CoV-2 Antigen Test Kit was tested on
ATTENTION clinical saliva specimens from 149 healthy persons
and 116 identified COVID-19 patients, using PCR as © 2021 UD-Bio. All rights reserved.
1. For in vitro diagnostic use only.
the reference method. The results are summarized as
2. Proper specimen collection storage and transit are All trademarks referenced are trademarks of either the
critical to the performance of this test. below: UD-Bio group of companies or their respective owners.
3. Use only once. Method PCR
SUM
4. Do not touch the reaction area of test strip. SARS- Result Positive Negative
5. Do not use test kit beyond the expiration date. CoV-2 Positive
110 1 111
6. Do not use the kit if the pouch is punctured or sealed Antigen
not well. Test Kit Negative 6 148 154
7. Do not freeze.
SUM 116 149 265
FREQUENTLY ASKED QUESTIONS (FAQs) Sensitivity 94.83% (95%CI:91.13%~95.65%)
I ACCIDENTALLY SPILLED THE TEST SOLUTION. IS Specificity 99.33% (95%CI:96.30%~99.88%)
IT HARMFUL? Accuracy 97.36% (95%CI:95.67%~97.70%)
If the test solution has been spilled, flush abundantly
-1-
 English/ Bahasa Malaysia Version 1.0

Carefully read these instructions prior to using SARS-CoV-2 5. Push the buffer tube on to the PERFORM THE TEST 3. Invalid results
Antigen Test Kit to ensure accurate results. perforated circle. 1. Take out the test card from the aluminum foil bag and The (C) line does not appears,
Children under 14 should be supported by an adult.
lay it flat on the test bench. repeat the test with a new test
BEFORE STARTING device.

Wash or sanitize your hands.

Make sure they are dry before starting.

PREPARE FOR THE TEST INSTRUCTIONS FOR ACTION ACCORDING TO

2. Unscrew the small lid of the tube. TEST RESULT
1. Check the expiration date on the box. Do not use if
the kit is expired. 1. In the event of a positive test result:
• There is currently a suspicion of COVID-19
infection.
2. Contained in this box
01 Test Cassette 02 Tube with buffer 03 Funnel
• Immediately contact a doctor/family doctor or the
local health authority.
• Comply with local self-insulation guidelines.
COLLECT THE SALIVA SPECIMEN • To have a PCR confirmation test carried out.
1. Do not place anything in the mouth including food, 2. In case of a negative test result:
drink, gum, tobacco, water and mouthwash • Continue to comply with all applicable rules
products for at least 10 minutes prior to collection of regarding contact with others and protective
oral fluid specimen. measures.
2. Spit your saliva until it reaches the second line of • An infection may be present even if the test is
3. Add 3 drops (approximately 80µl) of extracted
the tube negative.
specimen to the specimen well of the test device.
04 Bag • In case of suspicion, repeat the test after 1 - 2
days, as the coronavirus cannot be detected
accurately in all phases of an infection.
3. In case of an invalid test result:
• Possibly caused by faulty test execution.
• Repeat the test.
• If test results remain invalid, contact a doctor or
COVID 19 test center.
4. Read the result in 15~30minutes. Don't read the
3. Remove the funnel and put on the cap on the tube. results after 30minutes, it may give false results. DISPOSE THE TEST KIT
3. Keep the tube upright, twist to open the cap.
1. Place specimen, 2. Seal the Bag 3. Throw
tube, dropper and tightly. away the
test cassette into bag in
the disposal bag. waste
bin.
NOTE: The experiment should be done at 15~30℃,
humidity 35%～85%.

READ THE RESULT

4. Gently shake the extraction tube vertically for about 1. Positive results
4. Connect the funnel to the tube. 5 seconds to allow saliva mix well with the extraction
buffer. The presence of two lines, (T) and
(C), regardless of the intensity of the
test line, indicates the presence of
SARS-CoV-2 antigens.
2. Negative results

A single (C) Line appears, © 2021 UD-Bio. All rights reserved.

All trademarks referenced are trademarks of either the
UD-Bio group of companies or their respective owners.

-2-
English/ Bahasa Malaysia
BM
TestNGo COVID-19 Rapid Antigen
Saliva Test
SARS-CoV-2 Antigen Test Kit (Ujian Kendiri)
TUJUAN PENGGUNAAN
Kit ujian kendiri SARS-CoV-2 Antigen digunakan sebagai
ujian saringan pantas ‘in-vitro’ untuk pengesanan
kualitatif ‘antigen’ kepada virus SARS-CoV-2 yang
menyebabkan penyakit COVID-19 (coronavirus
infection) menggunakan sampel yang diperolehi melalui
sampel air liur (pensampelan kendiri/ persendirian).
PRINSIP UJIAN
Ujian SARS-CoV-2 Antigen Test Kit berdasarkan prinsip
‘kolloidal emas immunokromatografi untuk mengesan N
protin SARS-CoV-2 di saluran respiratori dan rembesan.
Bila sampel ditambah keatas peranti ujian, sampel akan
disedut ke dalam peranti ujian melalui pergerakan kapillari,
kemudian bercampur dengan antibody berlabel emas dan
bergerak merentangi membran yang terdahului diselaputi.
Sampel yang mengandungi antigen SARS-CoV-2 akan
dicekup oleh antibodi berlabel emas S1a yang terikat
kepada antibodi S1 yang telah ditetapkan di Kawasan Ujian
(T) pada membran, lalu menghasilkan satu jalur berwarna
menandakan keputusan ujian positif.
Sekiranya sampel ujian tidak mengandungi antigen
SARS-CoV-2 atau kepekatan antigen di bawah ambang
kepekaan pengesanan reagen bahanuji, jadi jalur berwarna
tidak akan menjelma di Kawasan Ujian (T) menghasilkan
keputusan ujian negatif.
Satu jalur berwarna akan menjelma di Kawasan Kontrol
(C), menandakan keputusan ujian yang sahih (sah).
KANDUNGAN KOTAK UJIAN
1 Arahan Pengguna 1 Tiub cecair buffer
1 Kaset Ujian 1 Beg
1 Corong Pengumpul
BAHAN KEPERLUAN YANG TIDAK DIBEKALKAN
Jam Pengira Masa
Pakaian dan peralatan perlindungan keselamatan
seperti sarung getah, topeng muka, cermin mata
keselamatan, kot makmal dan cecair pembasmi kuman
(disinfectant).
SYARAT PENYIMPANAN
Version 1.0
Kit ujian stabil sehingga tarikh luput (expiry date) atau 12 digunakan. Method PCR
bulan bila berada dan disimpan dalam beg aluminium ‘foil’ 6. Jangan guna ‘test kit’ jika beg ‘foil’ (pouch) sudah SUM
pada suhu antara 2 - 30 ° C. Bila tahap kelembapan berlubang atau tidak dimeterai rapat. SARS- Result Positive Negative
persekitaran melebihi 60%, kaset ujian perlu digunakan 7. Jangan letak ‘test kit’ di suhu paras beku (0 C).. CoV-2 Positive 110 1 111
sejurus selepas dibuka dari beg ‘aluminium foil’. Antigen
Sekiranya kelembapan adalah dibawah 60%, kaset ujian SOALAN LAZIM (FAQ) Test Kit Negative 6 148 154
boleh diguna dalam masa 1 jam selepas dibuka. SAYA TERSILAP TUMPAH CECAIR UJIAN. SUM 116 149 265
HAD KAEDAH METODOLOGI
MERBAHAYAKAH? Sensitivity 94.83% (95%CI:91.13%~95.65%)
Sekiranya cecair ujian tertumpah, bilas dengan air Specificity 99.33% (95%CI:96.30%~99.88%)
1. Novel SARS-CoV-2 adalah ujian saringan fasa akut yang banyak.
untuk pengesanan kualitatif. Sampel yang Accuracy 97.36% (95%CI:95.67%~97.70%)
dikumpulkan mungkin mengandungi kepekatan
Elakkan cecair ujian daripada tersentuh mata, kulit
dan mulut anda. Sekiranya terkena mata, bilas segara
antigen di bawah ambang kepekaan reagen bahan uji, MAKNA IKON
jadi keputusan ujian negative tidak boleh
dengan air berlebihan dan dapatkan bantuan
Guna satu kali Tahap had suhu
perubatan secepat mungkin. Sekiranya terkena pada
mengecualikan jangkitan dengan coronavirus. sahaja maksimum
2. Kit ujian Novel SARS-CoV-2 Antigen mengesan
kulit anda, basuh kawasan tersebut dengan sabun
dan bilas dengan air. Peranti perubatan
antigen coronavirus novel yang aktif (viable) dan yang Nombor Lot
Jangan menelan atau menyedut cecair ujian. jenis in-vitro
tidak-aktif (non-viable). Prestasi ujian bergantung (pengilangan)
Sekiranya berlaku pengambilan secara tidak sengaja, diagnostik
pada muatan antigen (antigen load) pada sampel dan
segera dapatkan bantuan perubatan. Sila rujuk
mungkin tidak berkorelasi dengan kultur sel dari Cukup untuk
kepada Arahan
sampel yang sama. Ujian positif tidak menolak ADAKAH UJIAN INI MENYAKITKAN? bilangan <n> ujian
Mengguna
kemungkinan kehadiran patogen lain. Justeru, Pengambilan sampel air liur tidak menyakitkan. Tetapi
keputusan ujian SARS-CoV-2 Antigen patut perlu diingatkan untuk mengikut langkah-langkah Pengilang Tarikh
dibandingkan dan disusuli dengan maklumat klinikal pengambilan sampel seperti yang dimaklumkan. Mengilang
dan keputusan ujian makmal yang lain untuk Guna sebelum
diagnosis yang tepat. APA PERLU SAYA LAKUKAN KEPADA UJIAN Tanda CE
(Tarikh)
3. Hasil ujian negatif mungkin berlaku jika tahap antigen ‘TEST KIT’ SELEPAS MEMBACA KEPUTUSAN? Simpan
yang diekstrak dalam sampel berada di bawah Simpan di tempat
Setelah merekodkan keputusan ujian anda, bungkus menghala arah
kepekaan ujian atau jika pengumpulan sampel semua komponen produk dengan teliti dan buang ke yang kering
Atas
berkualiti rendah. dalam sampah seperti sampah biasa. Basuh tangan Kendali dengan
4. Prestasi ujian belum dikenalpasti untuk memantau Had simpanan
anda dengan bersih setelah mengendalikan dan cermat (mudah
rawatan antivirus koronavirus novel. membuang komponen ‘test kit’. pecah)
bila bertindih
5. Keputusan ujian positif tidak boleh menolak
kemungkinan jangkitan bersama dengan patogen BAGAIMANA UJIAN INI BERFUNGSI? Wakil sah (Pengilang) di Komuniti Eropah
lain Ujian ini bertujuan untuk mengesan kehadiran antigen
6. Keputusan ujian negatif tidak boleh digunakan untuk SARS-CoV-2 dari sampel air liur. Antigen yang hadir di
MAKLUMAT AM
menolak kemungkinan (rule-in) jangkitan koronavirus virus SARS-CoV-2 boleh digunakan sebagai penanda
lain kecuali SARS-CoV-2. pendedahan kepada penyakit. Shenzhen Ultra-Diagnostics Biotec. Co., Ltd.
7. Kanak-kanak lebih cenderung mengeluarkan virus Room 701, No.71-3, Xintian Avenue, Xintian
APAKAH JIKA KEPUTUSAN SAYA NEGATIF? Community, Fuhai Street, Baoan District,
(virus-shedding) untuk jangka masa yang lebih lama Shenzhen, P.R.China 518103
Ujian antigen pantas hanya dapat mengesan
berbanding dengan orang dewasa; ini boleh Tel: +86-755-82599902
kehadiran antigen pada masa ujian. Keputusan ujian
menyebabkan perbezaan ‘test sensitivity’ antara Fax: +86-755-82599221
negative adalah mungkin jika kepekatan antigen dalam
orang dewasa dan kanak-kanak.
sampel berada di bawah had pengesanan ujian atau
8. Keputusan ujian negative adalah mungkin jika CMC Medical Devices & Drugs S.L.
jika sampel diambil atau dikendalikan dengan tidak C/ Horacio Lengo N°18, CP 29006, Málaga, Spain
kepekatan antigen dalam sampel berada di bawah
betul. Sekiranya anda mempunyai kontak dengan kes Tel: +34951214054
had pengesanan ujian atau jika sampel dikumpul atau
COVID-19 yang diketahui atau disyaki, sebagai Mail:info@cmcmedicaldevices.com
dikendalikan dengan tidak betul. Justeru keputusan
amalan terbaik, adalah disyorkan untuk melakukan
ujian negatif tidak boleh memutuskan tiada jangkitan WAKIL TEMPATAN SAH
ujian sekurang-kurangnya satu kali seminggu.
SARS-CoV-2 dan tindakan susulan haruslah diikuti
dengan kultur virus atau ujian PCR (Polymerase APAKAH KETEPATAN UJIAN INI?
Chain Reaction). Kit Ujian Antigen SARS-CoV-2 telah disahkan secara
klinikal mencapai ketepatan pengesanan yang tinggi,
PERHATIAN mencapai sensitiviti pengesanan relatif 94.83%
1. Untuk kegunaan in-vitro diagnostik sahaja. dan spesifisiti pengesanan relatif 99.33% dalam
2. Kaedah pengambilan, penyimpanan dan kajian klinikal kami.
pengendalian spesimen adalah amatlah kritikal Kit Ujian Antigen SARS-CoV-2 diuji pada sampel
kepada prestasi keputusan ujian. klinikal air liur dari 149 orang yang sihat dan 116
3. Ujian ‘test kit’ adalah untuk kegunaan sekali sahaja. pesakit COVID-19 yang dikenal pasti menggunakan
4. Jangan sentuh permukaan kawasan membran PCR sebagai kaedah rujukan. Keputusan ringkasan © 2021 UD-Bio. All rights reserved.
tindakbalas ujian ‘test kit’. adalah seperti di bawah.
All trademarks referenced are trademarks of either the
5. ‘Test kit yang melepasi tarikh luput tidak harus UD-Bio group of companies or their respective owners.
-3-
 English/ Bahasa Malaysia Version 1.0

Sila baca dan ikuti arahan yang dibentangkan dengan teliti 5. Tekan tiub buffer kedalam kotak seperti MULAKAN UJIAN 3. Ujian ‘Tidak Sah’ (Invalid)
sebelum memulakan ujian SARS-COV02 untuk keputusan
gambar dibawah.. 1. Keluarkan kaset ujian dari beg ‘alumuminium foil’ Kalau tiada garisan muncul di sebelah
terbaik.
Kanak-kanak dibawah umur 14 tahun dinasihatkan dan letak di permukaan yang rata huruf ‘C’, ini bermakna keputusan ujian
dibantu oleh orang dewasa. ini Tidak Sah (‘Invalid’) dan ujian baru
patut diulangi sekali lagi.
SEBELUM BERMULA
Basuh tangan dengan bersih dan pastikan tangan
adalah kering sebelum bermula. LANGKAH SETERUSNYA BERDASARKAN
KEPUTUSAN UJIAN
2. Putar dan tanggalkan penutup tiub yang kecil.
PERSEDIAAN SEBELUM UJIAN 1. Sekiranya keputusan ujian positif:
• jangkitan COVID-19 disyaki
1. Periksa tarikh luput pada kotak. Jangan guna
• Hubungi doktor / doktor keluarga atau pihak
sekira sudah melepasi tarikh luput.
berkuasa kesihatan tempatan
2. Kandungan dalam satu kotak • Patuhi garis panduan pihak berkuasa tempatan
mengenai pengasingan-kendiri (self-isolation)
01 Kaset Ujian 02 Tiub cecair buffer 03 Corong
PENGUMPULAN SAMPEL AIR LIUR • ambil tindakan susulan untuk menjalani ujian
PCR (Polymerase Chain Reaction)
1. Pastikan mulut anda kosong; tiada makanan,
minuman, gula-gula getah, tembakau (merokok), 2. Sekiranya keputusan ujian negatif:
cecair ubat kumur dsb sekurang-kurang 10 minit • Kekalkan langkah penjarakkan dan amalkan
3. Titiskan 3 titis (lebih kurang 80ul) cecair dalam tiub langkah penjagaan perlindungan keselamatan.
sebelum pengumpulan air liur. ke dalam telaga ujian disebelah huruf ‘S’. • Jangkitan mungkin hadir walau keputusan ujian
2. Ludah air liur kedalam tiub melalui corong sehingga
adalah negatif.
mencapai tahap garisan penanda kedua di tiub.
• Sekiranya jangkitan disyaki, ulangi ujian baru
setelah 1 - 2 hari, kerana coronavirus tidak dapat
04 Beg
dikesan dengan tepat dalam kesemua fasa
jangkitan.
3. Sekiranya keputusan ujian Tidak Sah (Invalid):
• Kemungkinan disebabkan oleh langkah langkah
pengujian yang tidak tepat
4. Mulakan jam pengira masa dan baca keputusan • Cuba ulangi ujian dengan ‘test kit’ baru
ujian selepas 15 – 30 minit. Jangan baca keputusan • Sekiranya ujian ulangan masih memberikan
ujian selepas 30 minit; risiko keputusan yang tidak keputusan Tidak Sah (Invalid), hubungi para
tepat/ salah. doctor atau or pusat ujian COVID-19.
3. Tegakkan tiub cecair buffer dan putar penutup 3. Tanggalkan corong dan letakkan semula penutup
tiub.
penyangga untuk membuka. PELUPUSAN KIT UJIAN
1. Letak kesemua 2. Tutup mulut 3. Buang
peranti beg dengan beg tadi
terpakai ke ketat. ke dalam
NOTA: Ujian patut dijalankan di keadaan suhu 15-30C dalam beg tong
dan kelembapan antara 35%-85%.. yang sampah
disediakan. biasa.

BACA KEPUTUSAN UJIAN

1. Ujian Positf
4. Goncang dan putar secara perlahan tiub ‘buffer’ Dua garisan muncul di sebelah huruf
4. Letakkan corong diatas tiub. selama 5 saat untuk campuran air liur dan cecair (T) dan (C), tak kira kedalaman
buffer bersebati.
warna (intensiti) bermakna
kehadiran antigen SARS-CoV-2.
2. Ujian Negatif

Hanya satu garisan muncul di

sebelah huruf ‘C’. © 2021 UD-Bio. All rights reserved.
All trademarks referenced are trademarks of either the
UD-Bio group of companies or their respective owners.
-4-
 ! Check the expiration date on the box. Do not use if the kit is expired.
! Do not place anything in the mouth including food, drink, gum, tobacco, water and mouthwash products for at least
10 minutes prior to collection of oral fluid specimen.

Step 1: Sample Preparation

Keep the tube upright,

Connect the funnel to the tube
twist to open the cap.

Step 2: Sample Collection

Second Line

Push the buffer tube on to the perforated circle. Spit your saliva until it reaches the second line of the tube

Step 3: Sample Extraction

Remove the funnel and put on
the cap on the tube.
Gently shake the extraction tube vertically
Unscrew the small lid
for about 5 seconds to allow saliva mix well
of the tube.
with the extraction buffer.

Step 4: Perform The Test

15 C C
C C C

T T T T T

S S
S S S

Read the result in

Add 3 drops (approximately 80µl) Negative Invalid
15~30minutes. Don't read the Positive
of extracted specimen to the
results after 30minutes, it may
specimen well of the test device.
give false results.

Step 5: Test Kit Disposal

Place specimen, tube, dropper and

Seal the Bag tightly. Throw away the bag in waste bin.
test cassette into the disposal bag.
 ! Periksa tarikh luput pada kotak. Jangan guna sekira sudah melepasi tarikh luput. Do not place anything in the mouth
! Pastikan mulut anda kosong; tiada makanan, minuman, gula-gula getah, tembakau (merokok), cecair ubat kumur dsb
sekurang-kurang 10 minit sebelum pengumpulan air liur.

Langkah 1: Penyediaan Sampel

Tegakkan tiub cecair buffer

Letakkan corong diatas tiub.
dan putar penutup
penyangga untuk membuka.

Langkah 2: Pengumpulan Sampel

Second Line

Tekan tiub buffer kedalam kotak seperti gambar dibawah. Ludah air liur kedalam tiub melalui corong sehingga
mencapai tahap garisan penanda kedua di tiub.

Langkah 3: Pengekstrakan Sampel

Tanggalkan corong dan letakkan
semula penutup tiub.
Goncang dan putar secara perlahan tiub
Putar dan tanggalkan
‘buffer’ selama 5 saat untuk campuran air
penutup tiub yang kecil.
liur dan cecair buffer bersebati.

Langkah 4: Pengujian Sampel

15 C C
C C C

T T T T T

S S
S S S

Mulakan jam pengira masa dan baca

Titiskan 3 titis (lebih kurang 80ul) keputusan ujian selepas 15 – 30 minit. Negatif Tidak Sah
Positif
cecair dalam tiub ke dalam telaga Jangan baca keputusan ujian selepas
ujian disebelah huruf ‘S’. 30 minit; risiko keputusan yang tidak
tepat/ salah.

Langkah 5: Pelupusan Kit Ujian

Letak kesemua alat peranti terpakai ke

Tutup mulut beg dengan ketat. Buang beg tadi ke dalam tong
dalam beg yang disediakan.
sampah biasa.