HTLV Antibody Diagnostic ELISA Kit

Developing Scientifically
Focusing on the Health

Sensitivity: 100%
Specificity: 99.97%
Incubation time: 60’+30’
Specimen volume: 50µl
Shelf-life: 13 months

31 Kexueyuan Rd. Changping, Beijing, China E-mail: wtexport@ystwt.com Tel: 0086 10 59528888 Website: www.ystwt.cn
What is HTLV?
The human T-cell lymphotropic virus (HTLV) is a member of
the family of Retroviridae, consisting of enveloped double
stranded RNA viruses and genetically not related to HIV1&2;
however, they have similar routes of transmission and can
have extremely long period of latency prior to manifestation
of disease. HTLV type 1 was reported in 1980 as the first
retrovirus shown to be pathogenic to humans. The virus
preferentially infects CD4+ lymphocytes while the infections
of CD8+ T lymphocytes are rare. In contrast to HTLV 1, HTLV
Analytical Specificity
30 HCV and HBsAg, 12 HIV, 2 Syphilis positive specimens
were tested with Wantai HTLV ELISA, the specificity
was 100%. In addition, 122 HIV false positive samples
were also tested, with no false positive results observed.
Clinical Specificity
In 2016, Wantai HTLV ELISA was used to screen

type 2 can infect all type of lymphocytes as well as the 2,766,000 blood donors in China. The overall
macrophages. HTLV 1&2 is transmitted transplacentally, positive rate for HTLV antibodies was
parentally via sexual contacts and infected blood. The 0.0054% with specificity of 99.97%. The results
diseases associated with HTLV infection are usually are given in the table below:

classified as malignant or nonmalignant clinical Positive

Province Specimens Initially True Positive Rate Specificity
presentations. HTLV 1 is endemic in southern Japan, the Positive （% ）

Caribbean and the US and many other scattered population In total 2,766,000 1091 145 0.0054 99.97%
through the world. HTLV 2 is endemic in some North Fujian 255,000 282 89 0.0349 99.92%
American Indian tribes but is detected mostly in Zhejiang 650,000 104 17 0.0026 99.99%
intravenous drug users and their sexual partners. GuangDong 708,000 199 15 0.0021 99.97%

Other 25
1,153,000 506 24 0.002 99.96%
Provinces

Device Description Study-I

Total of 1850 voluntary blood donors specimens were
Wantai HTLV 1+2 is an enzyme-linked immunosorbent assay
tested. The specificity was 99.80% (1848/1850)
(ELISA) for qualitative detection of antibodies to Human
T-Cell Lymphotropic Virus types 1 and/or 2 in human serum Study-II
screening of blood
or plasma. It is intended for In this study, total of 2232 specimens were tested
donors and as an aid for the diagnosis of clinical including 1395 archived, and 837 fresh specimens. The
conditions related to infection with HTLV-1 and/or HTLV-2. Specificity was 100%

Mean OD value of
Specimen Number Positive Negative
the negative results
Archived serum 1395 0 1395 0.030
Fresh serum 837 0 837 0.015
Total 2232 0 2232 --

Study-III
In a more recent international study (2010, European
donors), total of 357 random negative samples have been
tested. As the kit allows to use serum and EDTA plasma a
total of 137 EDTA samples and 220 serums were tested.
The specificity was 100%.

Study-IV
In a performance evaluation study conducted in Brazil in
2005. Wantai demonstrated specificity of 100%
(60/60).
Clinical Sensitivity Qualification Panel QRP712: Wantai HTLV 1+2 was
reactive with all positive samples. The results are shown in
Study-I
detail in the table below:
In a multicenter study conducted in China, total of 2339
specimens were tested with Wantai HTLV ELISA. 9 samples Wantai Comparison Test

were initially and repeatedly positive, these samples were OD OD/CO OD OD/CO

also confirmed as positive by Western Blot, hence 1 0.567 3.02 0.588 2.33

2 0.008 0.04 0.003 0.01

Sensitivity is 100% 3 0.898 4.78 1.113 4.42

4 0.274 1.46 0.259 1.03

Study-II
5 0.459 2.44 0.560 2.22
In a performance evaluation study conducted in Brazil in
6 o.278 1.48 0.221 0.88
2005, Wantai HTLV ELISA demonstrated sensitivity of
100% (10/10).
Anti HTLV I Performance Panel A02 PRA202 from
BBI: Wantai HTLV ELISA detected all positive samples
Trueness with a reactivity similar to the comparison test. The
Commercial HTLV panels were tested with Wantai HTLV results are shown in the table below:
ELISA and comparison HTLV ELISA in order to establish the
trueness in antibody detection of the kit on Wantai Comparison Test 1
well-established antibody positive samples. OD OD/CO OD OD/CO
PRA202-04 >3.999 21.27 3.597 7.33
Panels:
PRA202-08 >3.999 21.27 3.492 7.11
Anti HTLV I/II Mixed Titer Performance Panel
PRP205(M) from BBI PRA202-09 1.928 10.26 3.787 7.71

Anti-HTLV I/II Qualification Panel QRP712 PRA202-13 3.270 17.39 2.029 4.13
Lot:116214 from BBI PRA202-14 >3.999 21.27 3.805 7.75
Anti HTLV I Performance Panel A02 PRA202 from
PRA202-15 >3.999 21.27 3.763 7.66
BBI
PRA202-16 3.284 17.47 2.696 5.49
PRA202-17 1.830 9.73 1.715 3.49
Results:
PRA202-18 >3.999 21.27 3.062 6.24
Anti HTLV I/II Mixed Titer Performance Panel
PRA202-19 3.176 16.89 3.864 7.87
PRP205(M) from BBI : Wantai HTLV ELISA detected all
PRA202-20 >3.999 21.27 3.914 7.97
positive samples with a reactivity similar to the comparison
PRA202-21 2.807 14.93 2.683 5.46
tests. The results are shown in the table below:
PRA202-22 2.297 12.22 3.587 7.31
Wantai Comparison Test 1 Comparison Test 2
PRA202-23 >3.999 21.27 3.648 7.43
OD OD/CO OD OD/CO OD OD/CO
BBI 205-2 >3.999 21.27 2.958 11.69 2.503 5.10
PRA202-25 2.871 15.27 3.801 7.74
BBI 205-3 3.290 17.50 9.969 39.40 2.547 5.19
BBI 205-4 3.231 17.19 9.97 39.41 3.825 7.79
BBI 205-5 3.051 16.23 2.508 9.91 3.874 7.89
Conclusion: the results showed that Wantai HTLV ELISA
BBI 205-6 0.008 0.04 0.028 0.11 0.058 0.12
BBI 205-7 3.245 17.26 3.31 13.08 2.437 4.96 correctly detected positive samples with a reactivity
BBI 205-8 2.780 14.79 1.012 4.00 1.459 2.97
similar to the comparison tests hence
BBI 205-9 dil.1/20 FCS 3.285 17.47 0.313 1.24 3.914 7.97
BBI 205-11 >3.999 21.27 9.969 39.40 3.708 7.55 demonstrating the trueness in detection of the kit.
BBI 205-12 2.685 14.28 2.123 8.39 3.939 8.02
BBI 205-13 3.159 16.80 1.416 5.60 1.549 3.15
BBI 205-14 0.760 4.04 0.466 1.84 2.430 4.95
BBI 205-16 1.825 9.71 2.863 11.32 1.517 3.09
BBI 205-17 1.646 8.76 1.176 4.65 3.857 7.86
BBI 205-18 3.217 17.11 9.969 39.40 2.554 5.20
BBI 205-20 3.285 17.47 9.967 39.40 3.906 7.96
BBI 205-21 3.011 16.02 1.053 4.16 1.377 2.80
BBI 205-22 2.434 12.95 0.994 3.93 0.872 1.78
BBI 205-24 0.008 0.04 0.027 0.11 0.038 0.08
BBI 205-25 3.299 17.55 9.969 39.40 3.882 7.91
Principle and Procedures

Microwell strips pre-coated with

- recombinant HTLV 1/2 antigens HTLV 1/2 antibodies

Recombinant HTLV 1/2 antigens

HRP-conjugateded HTLV 1/2 antigens

Add 50µl of HRP-Conjugate

Add 50µl of Specimens/ Controls
Incubation at 37℃ for 60 min

5 Wash cycles

Add 50µl of Chromogen Solution A

and 50µl of Chromogen Solution B
Incubation at 37℃ for 30 min

Add 50µl of Stop Solution

Read by single wavelength

450nm or dual wavelength
600~650nm

Ordering Info
Cat. Product Specimen Pack size

WT-9196 HTLV Antibodies Diagnostic ELISA Kit Serum/Plasma 96T/kit