Khoa hoc Y D u p e I Y h o c d u p h o n g DOI 10 31276/VJST 64( 12) 24 28 Nghien ciru gia tri cua xet nghiem nhanh khang nguyen Espline® SARS CoV 2 trong chan doan mac COVID 19 T ran M a i L in h 1,[.]
Trang 1Khoa hoc Y- D u p e I Y h o c d u p h o n g DOI: 10.31276/V JS T 64( 12 ).2 4 -2 8
Nghien ciru gia tri cua xet nghiem nhanh khang nguyen Espline® SARS-CoV-2 trong chan doan mac COVID-19
T ra n M a i L in h 1, N g u y e n T h i N g o c B ic h 2, N g u y e n D u e T u a n 2, Nguyen Thi Ngoc Lan2*
‘TruongD ai hoc YD uoc, D ai hoc Q uoc gia H a N oi
2 Truong D ai hoc Y H a N oi
N g a y nhan bai 6 /4 /2 0 2 2 ; n g a y giri phan b ien 1 1/4/2022; n g a y nhan phan bien 9 /5 2 0 2 2 ; m a y c h ip nhan dan g 13/5 /2 0 2 2
Tom tat:
T rade tinh hinh dich benh C O V ID -1 9 dien bien p h iic tap, xet nghiem nhanh k hang nguyen la m ot phirong phap hieu qua de ph at hien ca nhiem m di, tir do co the nhanh chong each ly ngutri benh de ban che nguy co lay nhiem cung nhir tien hanh cac bien phap ho tr g cham soc sire khoe kjp thori Tuy nhien, d e dam bao tinh chinh xac va hieu qua cua xet nghiem , viec nghien cuai gia tri chan doan tra d e khi trien khai th u c te cua xet nghiem nhanh khang nguyen noi chung va E spline® SA R S-C oV -2 noi rieng la het su e quan trqng Trong nghien ciru nay, cac tac gia da danh gia gia tri chan doan cua xet nghiem nhanh k hang nguyen E spline® SA R S-C oV -2 tren m au benh pham dich ty; hau b ang phirong phap nghien ciru m o ta cat ngang T ong so 266 doi tirong nghien ciru, trong do co 99 benh nhan
m ac va 167 khong m ac C O V ID -1 9 dirge chan doan theo hirdng dan cua Bo Y te K et qua cho thay, do nhay va dac hieu chung cua xet nghiem nhanh khang nguyen E spline® SA R S-C oV -2 lan lirgt la 71,72 va 100% D o nhay cua xet nghiem trong cac nhom tuoi dirdi 1 8 ,1 8 -5 9 va tren 60 Ian lu g t la 61,54, 72,86 va 75% D o nhay cua xet nghiem trong nhom co thdi gian d iin bien benh diroi 7 ngay la 83,61% va nhom co gia tri chu ky ngu&ng (C t)<29,58 la 88%
X et n g h if m nhanh khang nguyen E spline® SA R S-C oV -2 dap irng d u g c nhirng khuyen cao cua To chirc Y te the gidi (W H O ) ve yeu cau danh cho xet n g h ifm nhanh k hang nguyen sir dung trong sang loc va chan doan C O V ID -1 9
lit win fle
D a i d i c h C O V I D - 1 9 g a y r a b a i v i r u s S A R S - C o V - 2 b a t
n g u o n a V u H a n , T r u n g Q u o c v a o c u o i n a m 2 0 1 9 s a u d o
n h a n h c h o n g la n r a t o a n t h e g i d i c h i t r o n g m o t t h d i g i a n
n g a n C a p n h a t d e n n g a y 1 / 4 / 2 0 2 2 , d a c o t d i t r e n 4 8 6 t r i e u
c a m a c v a h o n 6,1 t r i e u t n r d n g h o p t u v o n g d u o c g h i n h a n
tr e n t o a n c a u [ 1 ] , T a i V i e t N a m d a tr a i q u a 4 l a n s o n g d i c h
v d i tr e n 9 , 5 t r i e u c a n h i e m v a h o n 4 2 n g h i n t r u d n g h o p tur
\ o n g [ 2 ] , M o t t r o n g c a c b i e n p h a p d e n g a n c h a n s u l a y la n
c u n g n h ir h a n c h e n h u n g h a u q u a c u a d a i d j e h C O V I D - 1 9
la n h a n h c h o n g s a n g l o c , x a c d i n h c a n h i e m , tir d o n h a n h
c h o n g e a c h l y n g u d i b e n h d e h a n c h e n g u y c a l a y n h i e m
c i i n g n h u t i e n h a n h c a c b i e n p h a p h o t r g , c h a m s o c s u e k h o e
k i p t h d i
C o n h i e u p h u o n g p h a p d e p h a t h i e n v i r u s S A R S - C o V - 2
c i n g n h u c a b e n h C O V I D - 1 9 , m o i p h u a n g p h a p c o n h u n g
a s n fa u g c d i e m k h a c n h a u , p h i i h o p v d i n h i l n g m u c d i c h v a
imrik fe m h d i c h b e n h k h a c n h a u X e t n g h i e m R e a l T i m e - R T -
f C R s i r d u n g d e p h a t h i e n v a t c h a t d i t r u y e n c u a v i r u s t r e n
e a c m a a h e n h p h i m d i c h t y h a u h o a c b e n h p h a m d u d n g h o
"jiiac p t t m £ jn x i •y& K I j ji n g m e n a h m u e d u vn
h a p d u g c c o i l a t i e u c h u a n v a n g t r o n g c h a n d o a n c a b e n h
m a c C O V I D - 1 9 b d i d o n h a y v a d o d a c h i e u c a o [ 3 , 4 ] ,
T u y n h i e n , x e t n g h i e m R e a l T i m e - R T - P C R c u n g c o n h u n g
n h u g c d i e m n h u d o i h o i n h a n l u c c o c h u y e n m o n s a u , c a c
t r a n g t h i e t b j h i e n d a i , p h o n g x e t n g h i e m d a t t i e u c h u a n v e
a n t o a n s i n h h o c c u n g n h u t h d i g i a n t i e n h a n h x e t n g h i e m
d a i, d o d o a n h h u d n g t d i t h d i g i a n tr a k e t q u a c u n g n h u
n h u n g p h u a n g a n x ir l y t i e p t h e o [ 4 ] V d i u u d i e m d e t h u c
h i e n , t h d i g i a n tr a k e t q u a n h a n h , c h i p h i h a p l y , c a c x e t
n g h i e m n h a n h k h a n g n g u y e n S A R S - C o V - 2 la m o t t r o n g
n h u n g p h u a n g p h a p d u g c k h u y e n c a o s u d u n g d e p h a t h i e n
c a b e n h m a c C O V I D - 1 9 [ 3 , 5 ] C a p n h a t t h e o d i e n b i e n c u a
t i n h h i n h d i c h b e n h , h i e n n a y B o Y t e d a c h o p h e p sir d u n g
c a c x e t n g h i e m n h a n h k h a n g n g u y e n S A R S - C o V - 2 d e c h a n
d o a n x a c d i n h c a b e n h c u n g n h u d u a r a q u y e t d i n h d a b o
e a c h l y , x u a t v i e n d o i v d i n g u d i m a c C O V I D - 1 9 [6] , M o t
s o n g h i e n c u u c h i r a r a n g , d o n h a y c u a m o t s o x e t n g h i e m
n h a n h k h a n g n g u y e n c o g i a tr i r a t t o t t r e n n h u n g m a u b e n h
p h a m d u d n g h o h a p t h u t h a p tir n h ir n g b e n h n h a n c o t a i
l u g n g v i r u s c a o , t u a n g u n g v d i g i a i d o a n p h a t t a n , l a y la n
v i r u s m a n h [ 5 , 7 ] B e n c a n h n h u n g u u d i e m , c a c x e t n g h i e m
Trang 2Khoa hoc Y - Dupe I Y hoc clu phong ■
Evaluation of the clinical utility of novel
coronavirus antigen detection reagent Espline®
SARS-CoV-2 in COVID-19 diagnosis
Mai Linh Tran1, Thi Ngoc Bich Nguyen2, Due Tuan Nguyen2.
Thi Ngoc Lan Nguyen2*
1U niversity o f M e d ic in e a n d Pharmacy.
Vietnam N a tio n a l U niversity Hanoi
:H a n o i M e d ic a l U niversity
R e c e iv e d 6 A p r il 2 0 2 2 ; a c c e p te d 13 M a y 2 0 2 2
Abstract:
In the face o f the com plicated situation o f the C O V ID -1 9
epidem ic, rapid antigen diagnostic tests have been an
effective m ethod to detect new infections, thereby quickly
isolating patients to reduce further transm issions as
w ell as take tim ely health care m easures However, to
ensure the accuracy and effectiveness o f the test, it is
critical to evaluate the clinical diagnostic value before
im plem enting the rapid SA R S-C oV -2 antigen detection
tests in general and the E spline® SA R S-C oV -2 antigen
test, in particular This research aim ed to evaluate the
clinical utility o f E spline® SA R S-C oV -2 in C O V ID -1 9
diagnosis T he authors used a cross-sectional descriptive
study m ethod to assess the sensitivity and specificity o f the
SA R S-C oV -2 antigen test on a n asopharyngeal sw ab o f
266 study subjects in clu d in g 99 C O V ID -1 9 patients and
167 n o n -C O V ID -1 9 patients according to the guidelines
o f the M in istry o f H ealth T he results show ed the overall
sensitivity and specificity o f the E spline® SAR S-C oV -2
antigen test w ere 71.72 and 100% , respectively The
sensitivity o f the test in the group o f age <18, from 18 to
59 and >60 w ere 6 1 5 4 ,7 2 8 6 , and 75% , respectively The
sensitivity o f the test w ith disease progression tim e o f less
than 7 days w as 83.61% , and the group w ith C t <29.58
was 88% The E spline® SA R S-C oV -2 antigen rapid
test m eets the recom m endations o f the W orld H ealth
O rganization on the requirem ents for rapid antigen tests
in the screening and diagnosis o f C O V ID -19.
tion, SA R S-C oV -2.
n h a n h k h a n g n g u y e n S A R S - C o V - 2 c u n g t o n t a i n h u n g h a n
c h e n h ir d o n h a y , d o d a c h i e u t h a p h o n s o v d i x e t n g h i e m
R e a l T i m e - R T - P C R [ 4 - 8 ] D a c b i e t , c o n h i e u y e u t o c o t h e
a n h h u e m g t a i k e t q u a c u a x e t n g h i e m n h a n h k h a n g n g u y e n
S A R S - C o V - 2 , t r o n g d o p h a i k e t b i 2 y e u t o q u a n t r o n g la
do n h a y d o d a c h i e u c u a t i m g x e t n g h i e m v a q u a t r i n h l a y mau b e n h p h a m C h i n h v i v a y , b a t k y x e t n g h i e m n h a n h khang n g u y e n t n r o c k h i d u p e t r i e n k h a i t h u c h i e n r o n g r a i dbu can dupe d a n h g i a v e g i a trj c h a n d o a n t u d o d u a ra nhung khuyen cao phu hop t r o n g q u a t r in h sir d u n g v a p h i e n giai k£i qua xet nghiem.
X et nghiem nhanh khang nguyen E s p l i n e ® S A R S - C o V - 2 (Fujirebio Inc_ Nbat Ban) da dupe phat trien va chap thuan
su dung d£ chan doan SA R S-CoV-2 tai Nhat Ban [5, 9]
N guyen ly cua xet q gh ip n la phuong phap sac ky mien djeh
su dung khang th& d on d ong nkaa b*£t khang nguyen protein nucleocapsid (N -A g) cua virus SARS-CoY-2, dong then nhung khang the dan dong nay dupe ep a g hpp vdi eazym
p h o s p h a t a s e kiem (ALP) Khi m in dupe h a van cn a so
m a u , n e u t r o n g mau co khang nguyen protein a a d e o c a p o d
c u a v i r u s S A R S - C o V - 2 , phurc hop khang nguyen - kfaang i h i
d u p e h i n h t h a n h v a d i chuyen tren mang den vung cua so
d i e n g i a i T a i v a c h x e t n g h i e m ( T ) , phuc hop khang nguyen
- k h a n g t h e d u p e c o d i n h t r e n m a n g b b i mot loai khang the
n h a n b i e t k h a n g n g u y e n p r o t e i n n u c l e o c a p s i d khac Enzym
A L P c o n g h o p t r o n g phurc h o p k h a n g n g u y e n - k h a n g the
s e p h a n u n g v a i c h a t n e n v a l e n m a u o v a c h x e t n g h i e m ( T )
t r o n g p h a n c u a s o d i e n g i a i C a c k h a n g t h e d u t h u a t i e p tuc
d i c h u y e n tr e n m a n g v a d u p e c o d i n h t a i v a c h t h a m c h i e u (r) [ 5 ] T a i V i e t N a m , x e t n g h i e m n a y d a n a m t r o n g d a n h muc
d u p e B o Y t e c a p p h e p , t u y n h i e n n h u n g d a n h g i a v e g i a trj
c h a n d o a n l a m s a n g c u a x e t n g h i e m n a y c o n n h i e u k h o a n g
t r o n g , d o d o c h u n g t o i t h u c h i e n n g h i e n c u u n h a m m u c t i e u
d a n h g i a g i a trj c u a x e t n g h i e m n h a n h k h a n g n g u y e n E s p l i n e ®
S A R S - C o V - 2 tr o n g c h a n d o a n m a c C O V I D - 1 9
O o i tffqfng va phifoing phap nghien cub
Din tteffng
M a u b e n h p h a m d j e h t y h a u c u a 2 6 6 d o i t u p n g t h a m g ia
n g h i e n c u u d u p e l a y t a i t i n h B a c N i n h v a T P H a N o i Thcri
g i a n n g h i e n c u u tCr t h a n g 3 / 2 0 2 1 d e n t h a n g 5 / 2 0 2 1 ta i K h o a
X e t n g h i e m , B e n h v i e n D a i h o c Y H a N o i
Phuong phap nghien cieu
P h u o m g p h a p : N g h i e n c u u d u p e t h u c h i e n t h e o p h u o n g
p h a p m o t a c a t n g a n g Tien hanh nghien cun cac d o i tirong den kham , sang lo c CO V TD -19.
Trang 3Khoa hoc Y - Dupe I Y hoc du phong
S a u k h i d u g c g i a i t h i c h v a d o n g y t h a m g i a n g h i e n c u u s e d u g c
t i e n h a n h th u t h a p t h o n g tin t u o i , g i a i tin h , d i e n b i e n la m s a n g ,
t i e n sir d i c h t e v a d ir g e l a y m a u d i c h t y h a u b b i n h a n v i e n y
te d a ta p h u a n M a u b e n h p h a m d u g c v a n c h u y e n t r o n g d i e u
k i e n b a o q u a n la n h t a i 4 ° C , s a u d o d u g c l u u t r u t a i d ib u k i e n
- 8 0 ° C c h o t a i k h i t h u c h i e n x e t n g h i e m
M a u b e n h p h a m d i c h t y h a u c u a d o i t u g n g t h a m g i a
n g h i e n c u u d u g c t i e n h a n h t a c h c h i e t R N A b a n g k it t a c h c h i e t
Q I A a m p V ir a l R N A M i n i K i t ( Q i a g e n ) V a t c h a t d i tr u y e n
R N A c u a v i r u s S A R S - C o V - 2 d u g c p h a t h i e n t h e o q u y t r i n h
C h a r it e B e r l i n d a d u g c W H O v a B o Y t e k h u y e n c a o n h a
p h a n u n g R e a l T i m e - R T - P C R sir d u n g b o k i t L i g h t M i x ®
S a r b e c o V E - g e n e p l u s E A V c o n t r o l ( R o c h e ) [ 1 0 ] T h u
n g h i e m b a o g o m m o t k h u o n m l u d o i c h i m g d u a n g t i n h v a
m o t m a u k i e m s o a t c h i e t x u a t b e n t r o n g R N A , g e n m u c t i e u
l a g e n E c u a v i r u s S A R S - C o V - 2 , g i a i h a n p h a t h i e n d o n h a
s a n x u a t b a o c a o la 5 , 2 b a n s a o / p h a n u n g T h e o k h u y e n c a o
c u a n h a s a n x u a t , c a c m a u h i e n th j d u r in g c o n g c h u a n v a g i a
tr i n g u r i n g c h u k y C t < 3 6 d u g c c o i la d u a n g t i n h [ 1 1 ] B e n h
n h a n d u g c c h a n d o a n m a c C O V I D - 1 9 d u a t h e o t h o n g t in
l a m s a n g , t i e n s u d i c h t e , k e t q u a x e t n g h i e m R e a l T im e - R T -
P C R t h e o h u b n g d a n c u a B o Y t e [ 1 1 , 1 2 ] ,
B o n g th r ii, m a u b e n h p h a m d i c h t y h a u c u a d o i t u g n g
t h a m g i a n g h i e n c u u s e d u g c t i e n h a n h t h u c h i e n x e t n g h i e m
n h a n h k h a n g n g u y e n E s p l i n e ® S A R S - C o V - 2 d e d a n h g i a g ia
tri c u a x e t n g h i e m tr o n g c h a n d o a n m a c C O V I D - 1 9 M l u d i c h
t y h a u d u g c x ir l y t h e o h u b n g d a n c u a n h a s a n x u a t r o i d u g c
n h o v a o c u a s o m a u , t h e o d o i v a d g c k e t q u a t h e o h u o n g d a n
c u a n h a s a n x u a t: 1 v a c h ta i v i tr i ( r ) - a m t i n h ; 2 v a c h t a i c a
v j tr i ( r ) v a ( T ) - d u a n g t in h ; k h o n g x u a t h i e n v a c h t a i v i tr i
( r ) - k h o n g x a c d i n h D u a v a o k e t q u a t h u d u g c , c h u n g t o i s e
p h a n t i c h d o n h a y , d o d a c h i e u c h u n g c u a x e t n g h i e m n h a n h
k h a n g n g u y e n E s p l i n e ® S A R S - C o V - 2 , c u n g n h u d u a t h e o
c a c d a c d i e m n h u t u o i , g i a i t i n h , t h a i g i a n d i e n b i e n b e n h ,
C t c u a c a c d o i t u g n g n g h i e n c u u
P h a n tic h t h o n g k e : S o l i e u d u g c n h a p b a n g p h a n m e m
M i c r o s o f t E x c e l 2 0 1 6 v a p h a n t i c h b a n g p h a n m e m S T A T A
1 6 0
D a o d u e n g h ie n c u u : N g h i e n c u u t u a n t h u c a c q u y d j n h
% i d a o d u e n g h i e n c u u B o i t u g n g t h a m g i a n g h i e n c u u d a
A n n : g i a i t h i c h v a d o n g y n g h i e n c u u T h o n g t i n t h u t h a p
pHrim t n m g s a n g l o c c h a n d o a n b e n h n h a n m a c C O V I D - 1 9
■ i i i l i i h o n q u a d o g i u p e a c h ly d i e u tr i k i p t h a i v a d u n g d a n
c m i k b b n g la m c h a m c h e h o a c t h a y d o i c h a n d o a n
wm. A m | f | n i l b e n h n h a n
K et qua
D a c d i e m d o i t m n x g n g h i e n c u m
T r o n g s o 2 6 6 d o i t u g n g t h a m g i a n g h i e n c u u , n i l g i a i
c h i S m 6 0 , 9 % , n a m g i a i c h i e m 3 9 , 1 % T u o i t r u n g b i n h
c u a d o i t u g n g n g h i e n c u u la 4 3 , 1 5 ± 1 6 , 4 6 C o 9 9 t r o n g
t o n g s o 2 6 6 d o i t u g n g t h a m g i a n g h i e n d u g c x a c d i n h
m a c C O V I D - 1 9 c h i e m 3 7 , 2 1 % T r o n g s o n a y , t h a i g i a n
d i e n b i e n b e n h t r u n g b i n h l a 7 , 6 4 n g a y v a C t t r u n g b i n h
c u a x e t n g h i e m R e a l T i m e R T - P C R la 2 8 , 7 2 ( b a n g 1 ). Bang 1 Mot so d$c diem cua doi tiromg nghien ciru.
T*«g
Chan doan
Duang tinh Am tinh
Gioiunh
diln bien
Gia trj Ct
Gia tri cua xet nghiem nhanh khang nguyen Espline® SARS-CoV-2 trong chan doan mac COVID-19
N g h ie n c u u th u c h ie n tren 2 6 6 d o i t u g n g c h o th a y d o n h a y v a
d o d a c h ie u c h u n g c u a x e t n g h ie m n h a n h k h a n g n g u y e n E s p lin e ®
S A R S -C o V - 2 la n lu g t la 7 1 ,7 2 v a 1 0 0 % D o n h a y c u a x e t n g h ie m
tr o n g c a c n h o m tu o i d u b i 1 8 , tir 18 d e n 5 9 v a > 6 0 la n lu g t la 6 1 ,5 4 ,
7 2 ,8 6 v a 7 5 %
Trang 4Khoa hoc Y - Dupe I Y hoc du phong
D o n h a y c u a x e t n g h ie m n h a n h k h a n g n g u y e n E s p lin e ®
S A R S - C o V - 2 tr o n g n h o m c o th d i g ia n d ie n b ie n b e n h dirai 7 n g a y
la 8 3 ,6 1 % v a n h o m d ie n b ie n b e n h tren 7 n g a y la 5 0 % T h e o g ia
tri c u a C t, d o n h a y c u a x e t n g h ie m n h a n h k h a n g n g u y e n E s p lin e ®
S A R S -C o V - 2 ta i c a c k h o a n g tu p h a n v j th ii 1 v a 2 , th u 3 , th ii 4 la n
lu o t la 88, 6 4 v a 4 5 ,8 3 % (b a n g 2 , h in h 1).
Bang 2 Do nhay, do dac hieu cua xet nghiem nhanh khang
nguyen Espline® SARS-CoV-2 trong chan doan mSc COVID-19.
Chan doan
Ket qua test nhanh l<hang nguyen
h ieu
(nhilm-khong
tin h in k nhav
nhilm COVID-19)
T 6 n g
N h iem
K h o n g n h iem
99 71 28
71 ,7 2 100
167 0 167
N h ie m 34 21 13
N a m
K h o n g n h iem
6 1 ,7 6 100
G io ilin h 70 0 70
N h ie m 65 50 15
N S
K h o n g n h iem 97 0 97
76,92 100
N h ie m 13 8 5
0 - I 7
K h o n g n h iem 3 0 3
6 1 ,5 4 100
N h ie m 70 51 19
T uoi 18-59
K h o n g n h iem 132 0 132
72.86 100
N h ie m 16 4
>60
2
T h o i g i a i 0 -7 N h ie m 61 51 10 83j61
d ien b ien benh
(ngav) > 8 N h ie m 38 19 19 50
K h o a n g t i p h a n v j t h i l -2
(C t< 2 9 ,5 8 ) N h ie m 50 44 6 88
G ia tri C t K h o a n g t u p h a n v i t h u 3
(2 9 ,5 8 < C t< 3 2 ,0 6 ) N h ie m 25 16 9 64
K h o a n g t o p h a n v i th u 4
( 0 3 2 , 0 6 ) N h ie m 24 11 13 45 ,8 3
, 8
* % 0
"O—; p—
j«f~-I o o V <■ *
O
s
■m
5 20.00- ••
o j j -,— ,— ,— ,— ,— ,— ,— r
-ThM gian dltn bi£n bfofa (n&y)
KfrnirftwM|M
daikuAi
Hinh 1 K it qua xet nghiem nhanh khang nguyen Espline®
SARS-CoV-2, Ct cua xet nghiem Real Time-RT-PCR va thdi
gian dien bien cua benh.
Ban luan
T h e o k h u y e n c a o c u a W H O , c a c x e t n g h i e m n h a n h
k h a n g n g u y e n S A R S - C o V - 2 d o n g m o t v a i t r o q u a n t r o n g
t r o n g c h i e n lu c r e p h o n g n g u a v a k i e m s o a t t o n g t h e d o i
v a i C O V I D - 1 9 [ 1 3 , 1 4 ] N g h i e n c u u c u a c h u n g t o i d u g c
t h u c h i e n t r e n 2 6 6 d o i t u g n g c h o t h a y d o n h a y v a d o d a c
h i e u c h u n g c u a x e t n g h i e m n h a n h k h a n g n g u y e n E s p l i n e ®
S A R S - C o V - 2 la n l u g t l a 7 1 , 7 2 v a 1 0 0 % G i a trj d o d a c h i e u
t u a n g t u n h u k e t q u a n h a s a n x u a t c o n g b o c u n g n h u m o t
s o n g h i e n c u u k h a c v e x e t n g h i e m n h a n h k h a n g n g u y e n
E s p l i n e ® S A R S - C o V - 2 c u a K A o k i v a c s ( 2 0 2 1 ) [ 5 ] V e
g i a tr i d o n h a y , k e t q u a t h u d u g c c u a c h u n g t o i t u a n g t u
n h u n h u k e t q u a n h a s a n x u a t c o n g b o ( 6 6 , 7 % ) v a c a o horn
s o v d i n g h i e n c u u c u a K A o k i v a c s ( 2 0 2 1 ) [ 5 ] , S u k h a c
b i e t n a y c o t h e g i a i t h i c h d o n h o m d o i t u g n g d a c o d i e n
b i e n b e n h tr e n 1 0 n g a y t r o n g n g h i e n c u u c u a K A o k i v a c s
c h i e m t a i 8 0 , 9 5 % ( 1 0 2 / 1 2 6 ) K e t q u a t r e n c u n g t u a n g t u v a i
c a c n g h i e n c u u t r e n m o t s o l o a i x e t n g h i e m n h a n h k h a n g
n g u y e n k h a c n h u n g h i e n c h u c u a T W e i t z e l v a c s ( 2 0 2 0 ) [ 1 5 ] v a i d o n h a y c u a c a c x e t n g h i e m n h a n h khang nguyen
c u a R a p i G E N , B i o e a s y t e s t s la n l u g t la 6 2 va 85.0% do
d a c h i e u d d u la 1 0 0 % T h e o m o t nghien cuu cong b6 cua
W H O t h i d o n h a y v a do dac hieu trung binh cua cac loai xet
n g h i e m n h a n h khang nguyen lan lugt la 72 va 99,2% [13] Mot trong nhung yeu to quy^t djnh kha nang lay truyen cua COYTD-19 la tai lugng virus ton tai va d u gc fthat tan beri ngucri mang vim s Tai lugng vim s ca benh cung thay doi theo qua truth dien bien cua benh nhan mac C O V 1D -19 Nhieu nghien cuu chi ra rang, tai lugng vim s thuong cao nhat trong tuan dau t i e n k e tir k h i k h d i p h a t , t u a n g u n g
v a i g i a i d o a n p h a t t a n , l a y la n v i r u s m a n h n h a t v a s a u d o
g i a m d a n [8, 1 6 ] T h e o k h u y e n c a o c u a W H O , x e t n g h i e m
n h a n h k h a n g n g u y e n n e n d u g c d u n g a n g u d i n g h i n g d m a c
C O V I D - 1 9 t r o n g 5 - 7 n g a y d a u t i e n k e tir k h i k h d i p h a t ,
v a x e t n g h i e m n h a n h k h a n g n g u y e n S A R S - C o V - 2 c a n d a p
u n g d u g c y e u c a u t o i t h i e u v e d o n h a y l a > 8 0 % v a d o d a c
h i e u > 9 7 % t r e n n h o m d o i t u g n g n a y T r o n g n g h i e n c u u c u a
c h u n g t o i , d o n h a y c u a x e t n g h i e m n h a n h k h a n g n g u y e n
E s p l i n e ® S A R S - C o V - 2 t r e n n h o m d o i t u g n g d i e n b i e n b e n h
d u d i 7 n g a y l a 8 3 , 6 1 % K e t q u a n a y c a o horn m o t n g h i e n
c u n k h a c v e x e t n g h i e m n h a n h k h a n g n g u y e n E s p l i n e ®
S A R S - C o V - 2 c u a K A o k i v a c s ( 2 0 2 1 ) [ 5 ] , d o n h a y c u a x e t
n g h i e m tr e n n h o m d o i t u g n g d i e n b i e n b e n h d u d i 10 ngay la
7 3 , 3 % S ir k h a c b i e t n a y c o t h e d o n g h i e n c u u c u a chung t o i
l u a c h o n t h d i g i a n d a n h g i a la 7 n g a y s o v d i 10 ngay c u a K
A o k i v a c s ( 2 0 2 1 ) [ 5 ] , K e t q u a n g h i e n c u u tren mot s o l o a i
x e t n g h i e m n h a n h k h a n g n g u y e n k h a c c u a D.B Larremore (2 0 2 1) [ 1 7 ] , t r o n g t u a n d d u t i e n c o t r i e u chung do nhay c u a
x e t n g h i e m n h a n h k h a n g n g u y e n la 93.9% D ieu nay co the
d u g c g i a i t h i c h d o d o n h a y c u a xet nghiem nhanh khang
n g u y e n b e n c a n h p h u t h u o c v a o tai lugng vim s, chung con
p h u t h u o c v a o n h i e u y e u t o nhu nguyen ly xet nghiem hoac
k y t h u a t t h u t h a p , b a o quan mau benh ph§m Trong nghien
Trang 5Khoa hoc Y - Dt/pc I Y hoc du phong
c u u c u a c h u n g t o i , m a u b e n h p h a m d i c h t y h a u c u a d o i t u p n g
t h a m g i a n g h i e n c u u d u p e l a y b o i n h a n v i e n y t e d u p e d a o
t a o , t u y n h i e n x e t n g h i e m k h o n g d u p e t h u c h i e n n g a y t o i t h u c
d ia T r o n g q u a tr in h v a n c h u y e n v a b a o q u a n m a u b e n h
p h a m , t h a n h p h a n k h a n g n g u y e n p r o t e i n n u c l e o c a p s i d c u a
v ir u s S A R S - C o V - 2 c o t h e b i a n h h u c m g m o t p h a n , d o d o
a n h h u o n g t d i d o n h a y c u a x e t n g h i e m D o n g t h d i , k h o k h a n
t r o n g v i e c l a y m a u , d a c b i e t la m a u d i c h t y h a u , c u n g c o t h e
l a n g u y e n n h a n g i a i t h i c h c h o k e t q u a c u a c h u n g t o i v e d o
n h a y t h a p t r e n n h o m d o i t u p n g d u o i 1 8 t u o i ( c h i e m 6 1 , 5 4 % )
s o v o i c a c n h o m t u o i t r u c m g t h a n h ( 7 2 , 8 6 v a 7 5 % )
C o n h i e u p h u o n g p h a p d e d a n h g i a t a i l u p n g v i r u s c u a
b e n h n h a n , t u y n h i e n t r o n g t i n h h i n h d j e h b e n h , C t c u a x e t
n g h i e m R T - P C R l a m o t p h u o n g p h a p t h u a n t i e n v a c o g i a
tr i d e u d e l u p n g t a i l u p n g v i r u s T h e o h u d n g d a n c u a B o Y
t e , t h d i k y l a y t r u y e n c u a c a b e n h x a c d i n h d u p e t i n h t u 2
n g a y t r u d e k h i k h d i p h a t ( d o i v d i c a b e n h x a c d j n h k h o n g
c o t r i e u c h u n g t h i t h d i k y l a y t r u y e n d u p e t i n h tir 2 n g a y
t r u d e n g a y d u p e l a y m a u c o k e t q u a x e t n g h i e m d u o m g t i n h )
c h o d e n k h i k e t q u a x e t n g h i e m R T - P C R a m t i n h h o a c g i a
tr i C t > 3 0 [ 1 8 ] D o d o , d o n h a y c u a x e t n g h i e m n h a n h k h a n g
n g u y e n t h e o ta i l u p n g v i r u s t h o n g q u a C t c u a x e t n g h i e m
R T - P C R c u n g c o y n g h i a r a t q u a n t r o n g T r o n g n g h i e n c u u
c u a c h u n g t o i , d o n h a y c u a x e t n g h i e m n h a n h k h a n g n g u y e n
E s p l i n e ® S A R S - C o V - 2 la 88% t r e n n h o m d o i t u p n g n g h i e n
c u u m a c C O V I D - 1 9 c o C t < 2 9 , 5 8 D o n h a y c u a x e t n g h i e m
d o i v d i n h o m d o i t u p n g n g h i e n c u u m a c C O V I D - 1 9 c o
2 9 , 5 8 < C t < 3 2 , 0 6 v a C t > 3 2 , 0 6 l a n l u p t la 6 4 v a 4 5 , 8 3 % S u
t h a y d o i v e d o n h a y t h e o C t n a y t u o n g t u n h u k e t q u a c u a
F J C a n d e l v a c s ( 2 0 2 0 ) [ 1 9 ] , d o n h a y c u a t e s t n h a n h k h a n g
n g u y e n la 9 8 % d o i v d i C t < 2 5 v a 5 7 % d o i v d i C t > 3 0
T o e d o d o t b ie n d c a c lo a i v i m s d ie n ra ra t n h a n h , t r o n g th d i
g ia n q u a c a c b ie n c h u n g m d i c u a v i m s S A R S - C o V - 2 n h u D e l t a ,
O m i c r o n l i e n t u c x u a t h ie n V d i n g u y e n l y p h a t h i e n d u a
tr e n k h a n g n g u y e n p r o t e i n c u a v i m s , n h u n g d o t b i e n t r o n g c a c
b i e n c h u n g m d i c u a S A R S - C o V - 2 c o t h e la m a n h h u d n g t d i
g i a tri c h a n d o a n c u a c a c x e t n g h i e m n h a n h k h a n g n g u y e n n o i
c h u n g v a x e t n g h i e m n h a n h k h a n g n g u y e n E s p l i n e ® S A R S -
C o V - 2 n o i r ie n g T h e o k e t q u a n g h i e n c u u c u a Y S T a g a w a v a
c s (2 0 2 1) [20] c h o t h a y r a n g , x e t n g h i e m n h a n h k h a n g n g u y e n
E s p l i n e h i e u q u a t r o n g p h a t h i e n b i e n t h e D e l t a ( B 1 6 1 7 2 )
c u a v ir u s S A R S - C o V - 2 T u y n h i e n , t r o n g d i e u k i e n c u a n g h i e n
c u u n a y c h u n g t o i c h u a t h e d a n h g i a s a u v e g i a tr i c h a n d o a n
c u a x e t n g h i e m n h a n h k h a n g n g u y e n E s p lin e ® S A R S - C o V - 2
«4o* v e n h m g l o a i b i e n t h e c u a v i m s S A R S - C o V - 2
D o n h a \ v a d a c h i e u l a m s a n g c u a x e t n g h i e m n h a n h
§ K u y e n E s p l i n e * S A R S - C o V - 2 d a p vrng d u p e n h u n g
c a o c u a \S H O \ e y e u c a u d a n h c h o x e t n g h i e m
k n g n g u y e n S A R S - C o V - 2 G i a tr i c h a n d o a n p h u
v a o r iiO T e i a n l a y m a u x e t n g h i e m v a g i a m t r o n g n h o m
c O C t > 3 0
Tfll LIEU TH AM KHA0 [1] https://w w w w ho.int/director-general/speeches/detail/w ho- director-general-s-opening-remarks-at-the-media-briefing-on-COVID-19-
— 11 -march-2020.
[2] https://covidl9.who.int.
[3] h tt p s : // m o h g o v v n t i n - l i e n - q u a n / - / a s s e t _ p u b l i s h e r / vjYyM709aWnX/contentcac-xet-nghiem-xac-inh-COVID-19.
[4] M.A Kabir et al (202) “Diagnosis for COVID-19: Current status and future prospects" E x p e r t R e v ie w o f M o le c u l a r D i a g n o s tic s , 4, pp 1 -20 [5] K Aoki et al (2021), “Evaluation of clinical utility o f novel coronavirus antigen detection reagent, Espline® SARS-CoV-2”, J I n f e c t
C h e m o th e r 27(2) pp.319-322.
[6] https://thuvienphapluat.vn/cong-van/T he-thao-Y -te/C ong-
v a n -1 1011 -B Y T -K C B -2021 -xet-ng h iem -d e-p h at-h ien -n g u o i-m ac- COVID19-499016.aspx.
[7] L Porte, et al (2020), “Evaluation o f a novel antigen-based rapid detection test for the diagnosis o f SARS-CoV-2 in respiratory samples,
I n te r n a tio n a l J o u r n a l o f I n f e c tio u s D i s e a s e s , 9 9 , pp.328-333.
[8] R Wolfel, et al (2020), “Virological assessment of hospitalized patients with Covid-2019”, N a tu r e , 581, pp.465-469.
[9] https://www.medrxiv.org/content/10.1101/2020.06.16.20131243v 1 [ 10] https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh- 4042-QD-BYT-2021-huong-dan-tam-thoi-mo-hinh-tram-y-te-luu-dong- trong-dich-COVID19-485511 aspx.
[11] https://www.roche-as.es/lrnjjdf/MDx_40-0776_96_Sarbeco-E- gene_V200204_09164154001 %20( 1 ).pdf.
[12] https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh- 2008-QD-B YT-2021 -huong-dan-dieu-tri-COVID 19-do-chung-vi-rut- Corona-moi-472206.aspx.
[13] G.C.K Mak, et al (2021), “Evaluation of rapid antigen detection kit from the WHO emergency use list for detecting SARS-CoV-2”, J C lin
V iro l., DOI: 10.1016/j.jcv.2020.104712.
[ 14] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716730/ [15] T Weitzel, et al (2020), “Head-to-head comparison o f four antigen-based rapid detection tests for the diagnosis o f SARS-CoV-2 in respiratory samples”, B io R x iv , DOI: 10.1101/2020.05.27.119255 [16] L Zou, et al (2020), “SARS-CoV-2 viral load in upper respiratory specimens of infected patients”, N E n g l J M e d , DOI: 10.1056/ NEJMc2001737.
[17] D.B Larremore, et al (2021), “Test sensitivity is secondary to frequency and turnaround time for COVID-19 screening”, S c i A d v , DOI: 10.1126/sciadv.abd5393.
[18] https://thuvienphapluat.vn/cong-van/The-thao-Y-te/Cong-van- 11042-B YT-DP-2021 -dinh-nghia-ca-benh-COVIDl 9-499128.aspx [19] F.J Candel, et al (2020), “Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: Attitude in different clinical settings”, R ev E s p a n o l a Q u im i o te r
P u b l i c a c i o n O f S o c E s p a n o l a Q u im i o te r , DOI: 10.37201/req/120.2020 [20] Y.S Tagawa, et al (2021), “Comparative sensitivity o f rapid antigen tests for the delta variant (b 1.617.2) o f SARS-CoV-2”, V iru se s ,
DOI: 10.3390/vl3112183.