Product
URS-10A
German Technology
Roche model
10 parameters:
Bilirubin.
Urobilinogen.
Keton.
Blood
Protein.
Nitrit.
Leukocyte.
Glucose.
Specific Gravity.
PH.
.
URS-3
URS-2K
Autoscreen I Test Kit
From scimedx diagnostic.
1196L 96 Test Kit.
.
ANA: A positive result is observed as one of the four basic staining patterns seen individually or in various combinations. The characteristic patterns are best seen when viewed using high dry objectives.
1. Homogeneous (Diffuse) - An even, finely diffused fluorescence of the entire nucleus is seen.
2. Peripheral (Rim, shaggy) - The nuclear membrane is more intensely fluorescent than the central area.
3. Speckled - Numerous small "specks" of fluorescence throughout the nucleus.
4. Nucleolar - The nucleoli are uniformly stained and appear as 1 to 5 large spherical areas of fluorescence scattered throughout the nucleus.
P-ANCA Test Kit
From scimedx diagnostic.
6 well x 10 slides = 60 tests.
Positive: A positive result is reported when the cytoplasm of the human granulocyte substrate displays a 1 + or greater fluorescence. P-ANCA and C-ANCA will give a similar uneven granular staining of the cytoplasm, with formalin fixation. C-ANCA and P-ANCA may occur together C-ANCA antibodies are associated with classic Wegener's granulomatosis. P-ANCA (MPO) antibodies are associated with renal limited diseases.
Negative: A serum is considered negative for ANCA if the cytoplasm fluorescence is less then 1 +. Patients should be screened on ANA HEp2 (Cat. 1120L) substrate to avoid confusion with PSEUDO-ANCA. PSEUDO-ANCA will stain the cytoplasm of HEp2 cells whereas true ANCA will be negative on HEp2 unless the patient possesses both ANA and ANCA antibodies.
Endomysial Antibody Test Kit
From scimedx diagnostic.
5396EL 96 Tests.
Staining of the endomysium around the smooth muscle fibers in the monkey esophagus is considered positive. Patients reactions should be compared with the positive control contained in the kit. IgA SMA reactivity should be considered and eliminated before reporting a positive EmA. IgA SMA stains only the myofibril and not the network between them in which the endomysial antigen is found.
C-ANCA Test Kit
From scimedx diagnostic.
6 well x 10 slide.
Positive = C-ANCA is identified as a positive result when there is intense positive granular staining of the cytoplasm that extends to the border of the human granulocyte substrate displaying a 1+ or greater fluorescence and there is absence of nuclear staining.
Negative = A serum is considered negative for ANCA if there is an absence or minimal staining of the cytoplasm, or a low level of uniform (not granular) staining of the cytoplasm. The fluorescence is less than 1+ at 1:20 dilution. The multi-lobed nucleus should also be negative.
Sensitivity = 75.7%
Specificity = 86.4%
Agreement = 84.8%
.
nDNA Antibody (Crithidia luciliae) Test Kit
From scimedx diagnostic.
6100L 100 Test Kit.
10 well x 10 slide = 100 tests.
A positive result is seen as a fluorescent circular dot (kinetoplast), which is located against the cytoplasmic membrane in between the nuclear and flagellar, ends of the organism. Frequently, a serum will produce both nuclear and kinetoplast fluorescence simultaneously, this reaction will also be a positive.
Negative reactions include nuclear fluorescence alone or basal body (polar) fluorescence. Occasionally, non-specific cytoplasmic staining can produce diffuse staining which surround the negative image of the kinetoplast and the nucleus, but this is not read as a positive reaction.
Anti-nuclear Antibody Test Kit
From scimedx diagnostic.
14 well x 10 slide=140 tests.
Positive = A positive ANA result is reported when the HEp2 substrate displays a 1+ or greater fluorescence.
Negative = A serum is considered negative for ANA if the fluorescence is less than 1+ at 1:40 dilution.
Relative Sensitivity = 100%
Relative Specificity = 100%
Relative Agreement = 100%
Dvv test
Dimertest Latex
From Biomedica diagnostic.
No. of tests: 60 tests.
Package size: latex 2ml, positive 0.6 ml, negative 0.6 ml, and buffer 20 ml.
Specificity: 95.3%.
Precision: intra-assay CV.
25(OH)-Vitamin-DELISA Kit
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Linearity:
|
|
|
Recovery
(%) | |||
|
no |
25-OH-Vitamin-D
undiluted specimen (mlU/L) |
1:2 |
1:4 |
1:8 |
1:16 |
|
1 |
18.3 |
110 |
108 |
* |
* |
|
2 |
37.3 |
92 |
93 |
97 |
* |
|
3 |
58.9 |
98 |
111 |
92 |
89 |
|
4 |
95 |
103 |
106 |
108 |
115 |
|
5 |
112 |
104 |
103 |
99 |
116 |
Sensitivity: The minimum detectable concentration of 25-OH-Vitamin-D was determined by the optical density (OD) of zero standard minus three times the standard deviation (SD). The sensitivity of 25-OH-Vitamin-D kit is 3.5 ng/ml and values less than this amount should be reported as <3.5 ng/ml.
Precision:
intra-assay:
|
Specimen
no. |
No
of tests performed |
Means
(ng/ml) |
SD
|
CV
% |
|
1 |
10 |
12 |
1.7 |
14.2 |
|
2 |
10 |
54 |
2.21 |
4.1 |
|
3 |
10 |
104 |
2.28 |
2.2 |
Inter-assay:
|
Specimen
no. |
No
of tests performed |
Means
(ng/ml) |
SD |
CV
% |
|
1 |
24 |
10.26 |
1.71 |
16.7 |
|
2 |
24 |
33.26 |
3.66 |
11 |
|
3 |
24 |
112.00 |
3.80 |
3.4 |
.
TSH
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Linearity:
|
|
|
Recovery
(%) | |||
|
no |
hTSH
undiluted specimen (mlU/L) |
1:2 |
1:4 |
1:8 |
1:16 |
|
1 |
2.7 |
100 |
98 |
102 |
96 |
|
2 |
8.4 |
99 |
103 |
99 |
96 |
|
3 |
16.7 |
99 |
94 |
104 |
105 |
|
4 |
27.8 |
97 |
105 |
94 |
85 |
Sensitivity: The minimum detectable concentration of TSH was determined by adding three standard deviations to the mean optical density values of replicated zero standard. The minimum detectable dose using a standard curve is 0.1 mIU/L.
Precision:
intra-assay:
|
Specimen
no. |
No
of tests performed |
Means
(mlU/L) |
SD
(μg/ml) |
CV
% |
|
1 |
16 |
0.25 |
0.015 |
6 |
|
2 |
16 |
4.35 |
0.17 |
3.9 |
|
3 |
16 |
11.7 |
0.53 |
4.5 |
Inter-assay
|
Specimen
no. |
No
of tests performed |
Means
(mlU/L) |
SD
(μg/ml) |
CV
% |
|
1 |
20 |
0.25 |
0.02 |
8.0 |
|
2 |
20 |
4.4 |
0.31 |
7.0 |
|
3 |
20 |
12.1 |
1.02 |
8.4 |
T4
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Linearity:
|
|
|
Recovery
(%) | |||
|
no |
hT4
undiluted specimen (μg/ml) |
1:2 |
1:4 |
1:8 |
1:16 |
|
1 |
8.5 |
95 |
106 |
91 |
- |
|
2 |
12 |
94 |
91 |
109 |
- |
|
3 |
21 |
96 |
90 |
92 |
91 |
|
4 |
28 |
90 |
94 |
109 |
107 |
Sensitivity: The minimum detectable concentration of T4 was determined by adding three standard deviations to the mean optical density values of replicated zero standard. The minimum detectable dose using a standard curve is 0.1 μg/dcurve is 0.1 ng/ml.
Precision:
intra-assay:
|
Specimen
no. |
No
of tests performed |
Means
(μg/ml) |
SD
(μg/ml) |
CV
% |
|
1 |
24 |
3.6 |
0.18 |
5.0 |
|
2 |
24 |
9.5 |
0.55 |
5.7 |
|
3 |
24 |
16 |
0.58 |
3.6 |
Inter-assay
For more information.
|
Specimen
no. |
No
of tests performed |
Means
(μg/ml) |
SD
(μg/ml) |
CV
% |
|
1 |
10 |
3. |
0.21 |
5.5 |
|
2 |
10 |
9.9 |
0.76 |
7.6 |
T3
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No of tests: 96 tests.
Linearity:
|
|
|
Recovery
(%) | |||
|
no |
hT3 undiluted
specimen (ng/ml) |
1:2 |
1:4 |
1:8 |
1:16 |
|
1 |
1.4 |
103 |
97 |
108 |
- |
|
2 |
2.9 |
92 |
95 |
109 |
101 |
|
3 |
4.8 |
100 |
111 |
89 |
87 |
|
4 |
7.8 |
100 |
105 |
109 |
111 |
Sensitivity: The minimum detectable concentration of T3 was determined by adding three standard deviations to the mean concentration values of replicated zero standards. The minimum detectable dose using a standard curve is 0.1 ng/ml.
Precision:
Intra-assay:
|
Specimen
no. |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
24 |
0.53 |
0.02 |
4.7 |
|
2 |
24 |
1.63 |
0.05 |
3.1 |
|
3 |
24 |
5.45 |
0.17 |
3.1 |
Inter-assay:
|
Specimen
no. |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
10 |
0.57 |
0.05 |
8.8 |
|
2 |
10 |
1.66 |
0.06 |
3.6 |
|
3 |
10 |
5.65 |
0.28 |
4.9 |
.
Toxoplasma IgM
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Sensitivity: To evaluate test sensitivity, 30 positive samples confirmed by chemiluminecense and ELISA were used which all showed positive results. The PT-Toxoplasma-IgM-ELISA showed 100% sensitivity which is comparable to other diagnostic kits or methods.
Precision:
|
Intra-assay: |
No
of repeats |
Means
OD |
SD
|
CV
% |
|
Positive
sample |
10 |
1.2 |
0.08 |
6.6 |
|
Negative
sample |
10 |
0.028 |
0.003 |
10.7 |
|
Weak
sample |
10 |
0.275 |
0.014 |
5.1 |
|
Inter-assay: |
No
of repeats |
Means
OD |
SD
|
CV
% |
|
Positive
sample |
10 |
1.15 |
0.1 |
8.7 |
|
Negative
sample |
10 |
0.025 |
0.003 |
12 |
|
Weak
sample |
10 |
0.267 |
0.018 |
6.7 |
H.pylori lgG
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Sensitivity:101 / 104 = 97 %
Precision:
intra-assay:
|
no |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
24 |
6.5 |
0.3 |
4.6 |
|
2 |
24 |
18 |
0.9 |
5.0 |
|
3 |
24 |
45 |
2.0 |
4.4 |
Inter-assay:
|
no |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
10 |
8.7 |
0.71 |
8.1 |
|
2 |
10 |
18.8 |
1.76 |
9.4 |
|
3 |
10 |
43.5 |
2.90 |
6.7 |
Free PSA
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Linearity:
|
|
|
Recovery
(%) |
| |||
|
No. |
Free
PSA (ng/ml) level in undiluted specimen |
1:2 |
1:4 |
1:8 |
1:16 |
1:32 |
|
1 |
7.09 |
100 |
97.7 |
97.1 |
90.4 |
114 |
|
2 |
5.37 |
94.8 |
94.5 |
84.2 |
- |
- |
|
3 |
>10 |
- |
104 |
106 |
108 |
122 |
Precision:
Intra-assay:
|
no |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
24 |
0.18 |
0.0113 |
6.27 |
|
2 |
24 |
0.55 |
0.02 |
3.63 |
|
3 |
24 |
1.58 |
0.058 |
3.67 |
|
4 |
24 |
7.43 |
0.28 |
3.76 |
Inter-assay:
|
no |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
24 |
0.177 |
0.0153 |
8.64 |
|
2 |
24 |
0.558 |
0.034 |
6.09 |
|
3 |
24 |
1.73 |
0.1 |
5.78 |
|
4 |
24 |
5.9 |
0.31 |
5.25 |
.
Ferritin
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Linearity:
|
|
|
Recovery
(%) | |||
|
No. |
Ferritin
(ng/ml) level in undiluted specimen |
1:2 |
1:4 |
1:8 |
1:16 |
|
1 |
550 |
106 |
98 |
101 |
91 |
|
2 |
370 |
112 |
101 |
96 |
83 |
|
3 |
200 |
109 |
105 |
95 |
97 |
|
4 |
94 |
98 |
101 |
103 |
90 |
Precision:
Intra-assay:
|
no |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
24 |
16.5 |
0.60 |
3.6 |
|
2 |
24 |
365 |
11.7 |
3.2 |
|
3 |
24 |
585 |
32.0 |
5.4 |
Inter-assay:
|
no |
No
of tests performed |
Means
(ng/ml) |
SD
(ng/ml) |
CV
% |
|
1 |
10 |
20.3 |
1.20 |
5.9 |
|
2 |
10 |
372 |
18.7 |
5.0 |
|
3 |
10 |
566 |
52.6 |
9.3 |
CMV IgM
From Pshtaz Teb Zaman diagnostic.
Package size: 96 tests.
No. of tests: 96 tests.
Sensitivity: To evaluate test sensitivity, 45 positive samples confirmed by chemiluminecense and ELISA were used which all showed positive results. The PT-CMV-IgM-ELISA showed 100% sensitivity which is comparable to other diagnostic kits or methods.
Precision:
|
intra-assay
test result: |
No of
repeats |
OD Mean |
SD |
CV% |
|
Negative
sample |
10 |
0.04 |
0.003 |
7.5 |
|
Positive
sample |
10 |
1.023 |
0.06 |
5.8 |
|
Weak
sample |
10 |
0.29 |
0.02 |
6.9 |
For more information.
|
intre-assay
test result: |
No of
repeats |
OD Mean |
SD |
CV% |
|
Negative
sample |
10 |
0.052 |
0.004 |
7.7 |
|
Positive
sample |
10 |
1.038 |
0.05 |
4.8 |
|
Weak
sample |
10 |
0.31 |
0.015 |
4.8 |