TEST DIRECTORY

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Laboratory：Hachioji

○autoimmune-related test

TEST NAME

 SPECIMEN
REQUIREMENT
（ｍL）		 CONTAINER CAP COLOR STORE
TEMPERATURE
(STABILITY)		 TURNAROUND
TIME (DAY)		 METHODOLOGY REFERENCE RANGE
(UNIT)

Anti-nuclear antibody (ANA)

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 FA

Fluorescent antibody method (FA)
Using fluorochrome-labeled antibodies to the target antigen, the antigen-antibody reaction is carried out, and the fluorescence intensity is measured using fluorescence microscope.
The direct method uses fluorochrome-labeled antibodies that react directly with the antigen. The indirect method uses antibodies that react with the antigen first and then fluorochrome-labeled antibodies for the secondary reaction.

 < 40
(x)

Anti-DNA antibody, RIA

serum
0.2
S09
↓
A00 		Refrigeration
 2-4 RIA ammonium sulfate precipitation method

Radio immunoassay (RIA)
A target antigen is labeled with radioactive isotope (RI) and bound to its specific antibodies which is then competitively reacted with an antigen in a specimen. After the antigen-antibody reaction, the bound labeled antigens (bound) are separated from the unbound ones (free), and the antigen concentration is determined based on the proportion of radioactivity.
　To separate the bound and free antigens (B/F separation), the following methods are used. Solid-phase method:Antibodies are linked to the solid phase. Double antibody method: Antigen-antibody complexes are bound to the second antibody and precipitated. Ammonium sulfate precipitation method: Antigen-antibody complexes are precipitated by ammonium sulfate. PEG method: Antigenantibody complexes are precipitated by a precipitation reagent.

 ≦ 6.0
(IU/mL)

Anti-ss DNA antibody, IgG

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ≦ 25
(AU/mL)

Anti-ss DNA antibody, IgM

serum
0.3
S09
↓
A00 		Refrigeration
 2-8 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 17
(U/mL)

Anti-ds DNA antibody, IgG

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ≦ 12
(IU/mL)

Anti-ds DNA antibody, IgM

serum
0.3
S09
↓
A00 		Refrigeration
 2-8 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 6
(U/mL)

Anti-Sm antibody

serum
0.5
S09
↓
A00 		Refrigeration
 3-5 Ouchterlony

Ouchterlony method(Ouchterlony double immunodiffusion)
One of the gel-diffusion techniques, also called as ouchterlony double immunodiffusion, to identify antigen and antibody reactions. After antibodies and antigens are diffused in the gel plate, the presence or absence and the number of precipitin lines formed by the antigen-antibody reaction are confirmed.

 Negative
(x)

Anti-Sm antibody, CLEIA

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 10.0
(U/mL)

Anti-RNP antibody

serum
0.5
S09
↓
A00 		Refrigeration
 3-5 Ouchterlony

Ouchterlony method(Ouchterlony double immunodiffusion)
One of the gel-diffusion techniques, also called as ouchterlony double immunodiffusion, to identify antigen and antibody reactions. After antibodies and antigens are diffused in the gel plate, the presence or absence and the number of precipitin lines formed by the antigen-antibody reaction are confirmed.

 Negative
(x)

Anti-RNP antibody, CLEIA

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 10.0
(U/mL)

Anti-SS-A/Ro antibody

serum
0.5
S09
↓
A00 		Refrigeration
 3-5 Ouchterlony

Ouchterlony method(Ouchterlony double immunodiffusion)
One of the gel-diffusion techniques, also called as ouchterlony double immunodiffusion, to identify antigen and antibody reactions. After antibodies and antigens are diffused in the gel plate, the presence or absence and the number of precipitin lines formed by the antigen-antibody reaction are confirmed.

 Negative
(x)

Anti-SS-A/Ro antibody, CLEIA

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 10.0
(U/mL)

Anti-SS-B/La antibody

serum
0.5
S09
↓
A00 		Refrigeration
 3-5 Ouchterlony

Ouchterlony method(Ouchterlony double immunodiffusion)
One of the gel-diffusion techniques, also called as ouchterlony double immunodiffusion, to identify antigen and antibody reactions. After antibodies and antigens are diffused in the gel plate, the presence or absence and the number of precipitin lines formed by the antigen-antibody reaction are confirmed.

 Negative
(x)

Anti-SS-B/La antibody, CLEIA

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 10.0
(U/mL)

Anti-Scl-70 antibody

serum
0.5
S09
↓
A00 		Refrigeration
 3-5 Ouchterlony

Ouchterlony method(Ouchterlony double immunodiffusion)
One of the gel-diffusion techniques, also called as ouchterlony double immunodiffusion, to identify antigen and antibody reactions. After antibodies and antigens are diffused in the gel plate, the presence or absence and the number of precipitin lines formed by the antigen-antibody reaction are confirmed.

 Negative
(x)

Anti-Scl-70 antibody, CLEIA

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 10.0
(U/mL)

Anti-RNA polymerase III antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 28
See the following criteria.

Anti-centromere antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 10.0
See the following criteria.

Anti-Jo-1 antibody

serum
0.3
S09
↓
A00 		Refrigeration
 3-5 Ouchterlony

Ouchterlony method(Ouchterlony double immunodiffusion)
One of the gel-diffusion techniques, also called as ouchterlony double immunodiffusion, to identify antigen and antibody reactions. After antibodies and antigens are diffused in the gel plate, the presence or absence and the number of precipitin lines formed by the antigen-antibody reaction are confirmed.

 Negative
(x)

Anti-Jo-1 antibody, CLEIA

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 10.0
(U/mL)

Anti-ARS antibody

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 Negative < 25.0

Rheumatoid factor (RF), quantitative

serum
0.5
S09
↓
A00 		Refrigeration
 2-4 Latex aggulutination immunoassay ≦ 15
(IU/mL)

Rheumatoid factor, IgG

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 2.00

Anti-galactose deficient IgG antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ECLIA

Electro chemiluminescence immunoassay (ECLIA)
Antibody-bound beads are reacted with antigens that are secondarily reacted with antibodies labeled with rutheniumpyridine complexes, which promotes the electrochemical reaction. The emission intensity of ruthenium-pyridine complexes is measured.

 < 6.0
(AU/mL)

Anti-cyclic citrullinated peptide (CCP) antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 4.5
(U/mL)

Anti-mitochondrial antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 FA

Fluorescent antibody method (FA)
Using fluorochrome-labeled antibodies to the target antigen, the antigen-antibody reaction is carried out, and the fluorescence intensity is measured using fluorescence microscope.
The direct method uses fluorochrome-labeled antibodies that react directly with the antigen. The indirect method uses antibodies that react with the antigen first and then fluorochrome-labeled antibodies for the secondary reaction.

 Negative (< 20)
(x)

Anti-mitochondrial M2 antibody

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 7.0

Anti-smooth muscle antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 FA

Fluorescent antibody method (FA)
Using fluorochrome-labeled antibodies to the target antigen, the antigen-antibody reaction is carried out, and the fluorescence intensity is measured using fluorescence microscope.
The direct method uses fluorochrome-labeled antibodies that react directly with the antigen. The indirect method uses antibodies that react with the antigen first and then fluorochrome-labeled antibodies for the secondary reaction.

 Negative (< 40)
(x)

Anti-parietal cell antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 FA

Fluorescent antibody method (FA)
Using fluorochrome-labeled antibodies to the target antigen, the antigen-antibody reaction is carried out, and the fluorescence intensity is measured using fluorescence microscope.
The direct method uses fluorochrome-labeled antibodies that react directly with the antigen. The indirect method uses antibodies that react with the antigen first and then fluorochrome-labeled antibodies for the secondary reaction.

 Negative (< 10)
(x)

Anti-intrinsic factor antibody

serum
0.8
S09
↓
A00 		Refrigeration
 2-6 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 (-)

Fecal calprotectin

stool
F30 Freeze
（28 days）
 3-7 FEIA

Fluorescence enzyme immunoassay (FEIA)
One of the techniques of EIA. Using either enzyme-labeled antigen or antibody as a labeled-substance, the antigenantibody reaction is carried out. After adding a fluorescence substrate, the fluorescence intensity is measured.

 ≦ 50.0
(mg/kg)

Fecal calprotectin

stool
1g
F00 Freeze
 5-9 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ＜94.0
(μg/g)

Leucine-rich alpha 2 glycoprotein (LRG)

serum
0.5
S09
↓
A00 		Refrigeration
（28 days）
 2-4 Latex agglutination immunoassay < 16.0
(cutoff)
(μg/mL)

Anti-melanoma differentiation associated gene 5 (MDA5) antibody

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ＜32
Negative

Anti-Mi-2 antibody

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ＜53
Negative

Anti-transcriptional intermediary factor 1-γ(TIF1- γ) antibody

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ＜32
Negative

Anti-thyroid peroxidase antibody (Anti- TPO antibody), CLEIA

serum
0.5
S09
↓
A00 		Refrigeration
（21 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 ＜3.3
(IU/mL)

Anti-thyroglobulin antibody, CLEIA

serum
0.5
S09
↓
A00 		Refrigeration
（21 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 ＜19.3
(IU/mL)

Thyroid stimulating antibody (TSAb)

serum
0.3
S09
↓
A00 		Refrigeration
（21 days）
 2-4 Bioassay ＜110
(%)

INACTIVE
TSH receptor antibody（Suspended beyond orders placed 03-31-2021）

serum
0.2
S09
↓
A00 		Refrigeration
 2-4 Radioreceptorassay (RRA)

Radioreceptor assay (RRA)
RRA is based on the same assay principle as RIA. Instead of an antibody, a receptor is used, and the biological activity is determined by the reactivity.

 ≦ 15
(%)

TSH receptor antibody, quantitative

serum
0.4
S09
↓
A00 		Refrigeration
 2-4 Radioreceptorassay (RRA)

Radioreceptor assay (RRA)
RRA is based on the same assay principle as RIA. Instead of an antibody, a receptor is used, and the biological activity is determined by the reactivity.

 < 1.0
(IU/L)

TSH receptor antibody, CLEIA

serum
0.8
S09
↓
A00 		Refrigeration
（21 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 ＜2.0
(IU/L)

Anti-GAD antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 5.0
(U/mL)

Anti-IA-2 antibody

serum
0.6
S09
↓
A00 		Refrigeration
（28 days）
 3-9 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 0.6
(U/mL)

Zinc transporter 8 (ZnT8) antibody

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 Please contact us in advance. ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 15.0
(U/mL)

Insulin antibody

serum
0.3
S09
↓
A00 		Refrigeration
 3-7 RIA

Radio immunoassay (RIA)
A target antigen is labeled with radioactive isotope (RI) and bound to its specific antibodies which is then competitively reacted with an antigen in a specimen. After the antigen-antibody reaction, the bound labeled antigens (bound) are separated from the unbound ones (free), and the antigen concentration is determined based on the proportion of radioactivity.
　To separate the bound and free antigens (B/F separation), the following methods are used. Solid-phase method:Antibodies are linked to the solid phase. Double antibody method: Antigen-antibody complexes are bound to the second antibody and precipitated. Ammonium sulfate precipitation method: Antigen-antibody complexes are precipitated by ammonium sulfate. PEG method: Antigenantibody complexes are precipitated by a precipitation reagent.

 < 0.4
(U/mL)

Anti-acethylcholine receptor antibody(anti-AChR antibody)

serum
0.3
S09
↓
A00 		Refrigeration
 3-7 RIA

Radio immunoassay (RIA)
A target antigen is labeled with radioactive isotope (RI) and bound to its specific antibodies which is then competitively reacted with an antigen in a specimen. After the antigen-antibody reaction, the bound labeled antigens (bound) are separated from the unbound ones (free), and the antigen concentration is determined based on the proportion of radioactivity.
　To separate the bound and free antigens (B/F separation), the following methods are used. Solid-phase method:Antibodies are linked to the solid phase. Double antibody method: Antigen-antibody complexes are bound to the second antibody and precipitated. Ammonium sulfate precipitation method: Antigen-antibody complexes are precipitated by ammonium sulfate. PEG method: Antigenantibody complexes are precipitated by a precipitation reagent.

 ≦ 0.2
(nmol/L)

Muscle-specific receptor tyrosine kinase antibody (anti-MuSK antibody)

serum
0.3
S09
↓
A00 		Refrigeration
（21 days）
 3-9 RIA

Radio immunoassay (RIA)
A target antigen is labeled with radioactive isotope (RI) and bound to its specific antibodies which is then competitively reacted with an antigen in a specimen. After the antigen-antibody reaction, the bound labeled antigens (bound) are separated from the unbound ones (free), and the antigen concentration is determined based on the proportion of radioactivity.
　To separate the bound and free antigens (B/F separation), the following methods are used. Solid-phase method:Antibodies are linked to the solid phase. Double antibody method: Antigen-antibody complexes are bound to the second antibody and precipitated. Ammonium sulfate precipitation method: Antigen-antibody complexes are precipitated by ammonium sulfate. PEG method: Antigenantibody complexes are precipitated by a precipitation reagent.

 < 0.02
(nmol/L)

Anti-P/Q-type voltage-gated calcium channels (Anti-P/Q VGCCs antibody)

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-8 RIA

Radio immunoassay (RIA)
A target antigen is labeled with radioactive isotope (RI) and bound to its specific antibodies which is then competitively reacted with an antigen in a specimen. After the antigen-antibody reaction, the bound labeled antigens (bound) are separated from the unbound ones (free), and the antigen concentration is determined based on the proportion of radioactivity.
To separate the bound and free antigens (B/F separation), the following methods are used. Solid-phase method:Antibodies are linked to the solid phase. Double antibody method: Antigen-antibody complexes are bound to the second antibody and precipitated. Ammonium sulfate precipitation method: Antigen-antibody complexes are precipitated by ammonium sulfate. PEG method: Antigenantibody complexes are precipitated by a precipitation reagent.

 ＜30.0
(pmol/L)

Anti-desmoglein 1 antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 20.0
(U/mL)

Anti-desmoglein 3 antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 20.0
(U/mL)

BP180 antibody (serum anti-BP180NC16a antibody)

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 9.0
(U/mL)

Anti-glomerular basement membrane antibody (anti-GBM antibody)

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 3.0
(U/mL)

Sperm immobilizing antibody

serum
0.3
S09
↓
A00 		Freeze
（9 months）
 Please contact us in advance. Immobilization method(Isojima method) (-)
See the following criteria.

Sperm immobilizing antibody (SI50)

serum
0.3
S09
↓
A00 		Freeze
（9 months）
 Please contact us in advance. Immobilization method(Isojima method) < 1.0

Lupus-anticoagulant

Immediately
plasma
1.0
PC5
↓
A00 		Freeze
 2-4 APTT clotting time ≦ 46.5
(seconds)

Lupus-anticoagulant

Immediately
plasma
1.0
PC5
↓
A00 		Freeze
（21 days）
 2-4 Diluted Russell's viper venom time test < 1.3

Lupus-anticoagulant

Immediately
plasma
1.0
PC5
↓
A00 		Freeze
 2-4 Phospholipid neutralization method ≦ 1.16

Anti-cardiolipin β2GP I complex antibody (anti-CL-β2 GP I antibody)

serum
0.3
S09
↓
A00 		Freeze
（1 month）
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 3.5
(U/mL)

INACTIVE
Anti-cardiolipin antibody, IgG（Suspended beyond orders placed 03-31-2022）

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 10
(U/mL)

INACTIVE
Anti-cardiolipin antibody, IgM（Suspended beyond orders placed 03-31-2022）

serum
0.3
S09
↓
A00 		Refrigeration
 3-5 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 8
(U/mL)

Anti-β2 glycoprotein Ⅰ antibody, IgG

serum
0.3
S09
↓
A00 		Refrigeration
（21 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 ＜0.7
(U/mL)

Anti-β2 glycoprotein Ⅰ antibody, IgM

serum
0.3
S09
↓
A00 		Refrigeration
（21 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 ≦17.5
(U/mL)

Anti-cardiolipin antibody, IgG

serum
0.3
S09
↓
A00 		Refrigeration
（7 days）
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ≦12.3
(U/mL)

Anti-cardiolipin antibody, IgM

serum
0.3
S09
↓
A00 		Refrigeration
（14 days）
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ≦20.8
(U/mL)

Anti-platelet antibody

serum
0.4
S09
↓
A00 		Refrigeration
 3-6 Mixed passive hemagglutination(MPHA) Negative

Specified days
Platelet associated Immunoglobulin G (PAIgG)

whole blood (with ACD-A)
7.5
PAC Refrigeration
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ≦ 46
(ng/107 cells)

HIT antibody (Platelet factor 4-heparin complex antibody)

Immediately
plasma
0.5
PC2
↓
A00 		Freeze
 2-6 Latex turbidimetry Negative: < 1.0
(U/mL)

Serine proteinase 3-antineutrophil cytoplasmic antibody (PR3-ANCA)

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 3.5
(U/mL)

Myeloperoxidase-antineutrophil cytoplasmic antibody (MPO-ANCA)

serum
0.3
S09
↓
A00 		Refrigeration
（28 days）
 2-4 CLEIA

Chemiluminescent enzyme immunoassay (CLEIA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies.
After adding a chemiluminescent substrate, the emission intensity is measured.

 < 3.5
(U/mL)

Anti-LKM-1 antibody

serum
0.3
S09
↓
A00 		Refrigeration
 2-8 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 < 17
See the following criteria.

Immune complex (Monoclonal RF)

serum
0.2
S09
↓
A00 		Freeze
（21 days）
 2-8 EIA

Enzyme immunoassay (EIA)
EIA is based on the same assay principle as RIA. Using either enzyme-labeled antigen or antibody as a labeledsubstance, the antigen-antibody reaction is carried out. After adding a chromogenic substrate, the enzyme activity is measured.

 < 4.2
(μg/mL)

Anti-aquaporin 4 antibody

serum
0.4
S09
↓
A00 		Freeze
（28 days）
 2-8 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 Negative: < 3.0
(U/mL)

Skin autoantibody, direct method

skin tissues
5×5×3mm
VP1 Freeze
 12-14 Fluorescent antibody staining

INACTIVE
Immune complex (C1q)（Suspended beyond orders placed 05-14-2022）

serum
0.3
S09
↓
A00 		Freeze
 2-4 ELISA

Enzyme-linked immunosorbent assay (ELISA)
Antibodies linked to the solid phase are reacted with antigens that are secondarily reacted with enzyme-labeled antibodies. After adding a chromogenic substrate, the enzyme activity is measured.

 ≦ 3.0
(μg/mL)

INACTIVE
Anti-thyroid microsomal antibody (Microsome test)（Suspended beyond orders placed 12-01-2022）

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 Particle agglutination(PA)

Particle agglutination (PA)
Using antigen- or antibody-coated gelatin particles (sensitizing particles), etc., the antigen-antibody reaction is carried out. The existence of the antibody or antigen is determined based on appearance or non-appearance of clots.

 Negative (< 100)
(x)

INACTIVE
Anti-thyroid thyroglobulin antibody (Thyroid test)（Suspended beyond orders placed 12-01-2022）

serum
0.3
S09
↓
A00 		Refrigeration
 2-4 Particle agglutination(PA)

Particle agglutination (PA)
Using antigen- or antibody-coated gelatin particles (sensitizing particles), etc., the antigen-antibody reaction is carried out. The existence of the antibody or antigen is determined based on appearance or non-appearance of clots.

 Negative (< 100)
(x)

INACTIVE
Anti-thyroglobulin antibody（Suspended beyond orders placed 09-30-2021）

serum
0.5
S09
↓
A00 		Refrigeration
 2-4 ECLIA

Electro chemiluminescence immunoassay (ECLIA)
Antibody-bound beads are reacted with antigens that are secondarily reacted with antibodies labeled with rutheniumpyridine complexes, which promotes the electrochemical reaction. The emission intensity of ruthenium-pyridine complexes is measured.

 < 28
(IU/mL)

INACTIVE
TSH receptor antibody (3rd generation)（Suspended beyond orders placed 09-30-2021）

serum
0.5
S09
↓
A00 		Refrigeration
 2-4 ECLIA

Electro chemiluminescence immunoassay (ECLIA)
Antibody-bound beads are reacted with antigens that are secondarily reacted with antibodies labeled with rutheniumpyridine complexes, which promotes the electrochemical reaction. The emission intensity of ruthenium-pyridine complexes is measured.

 < 2.0
(IU/L)

INACTIVE
Anti-thyroid peroxidase antibody (Anti-TPO antibody)（Suspended beyond orders placed 09-30-2021）

serum
0.5
S09
↓
A00 		Refrigeration
 2-4 ECLIA

Electro chemiluminescence immunoassay (ECLIA)
Antibody-bound beads are reacted with antigens that are secondarily reacted with antibodies labeled with rutheniumpyridine complexes, which promotes the electrochemical reaction. The emission intensity of ruthenium-pyridine complexes is measured.

 < 16
(IU/mL)

INACTIVE
TSH receptor antibody (TSAb)（Suspended beyond orders placed 03-31-2023）

serum
0.8
S09
↓
A00 		Refrigeration
（21 days）
 3-5 Bioassay EIA ≦ 120
(%)

INACTIVE
Anti-pituitary antibody 1（Suspended beyond orders placed 09-29-2020）

serum
0.9
S09
↓
A00 		Freeze
 7-13 Indirect fluorescent antibody method (-)

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