Laboratory：Akiruno
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- HBs Antigen（Suspended beyond orders placed 03-31-2021）
Laboratory：Akiruno
○HBs Antigen（Suspended beyond orders placed 03-31-2021）
CODE：00366 5
-
TEST NAME
SPECIMEN
REQUIREMENT
（ｍL） CONTAINER CAP COLOR STORE
TEMPERATURE
(STABILITY) TURNAROUND
TIME (DAY) METHODOLOGY REFERENCE RANGE
(UNIT) -
HBs Antigen（Suspended beyond orders placed 03-31-2021）
Serum
0.2
S09
↓
A00
2-4 Magnetized particle aggregation method (MAT method) Negative (less than 8) (x)
COMMENT
[0366 8, 6488 8]About HBs antigen
[Diagnosis of HBV infection]
When diagnosing hepatitis B virus (HBV) infection, as with other immunoassays, please do not rely solely on the positive or negative results obtained using this product, but make a comprehensive decision by also taking into account the results of other tests, such as HBc antibody measurement and quantitative HBV-DNA testing, as well as the clinical progress. Please pay particular attention to usage in the following cases.
1. Screening test during health checkup
Use detection reagents using EIA method/chemiluminescence method etc. with as high detection sensitivity as possible, and please be careful when using detection reagents with low detection sensitivity using immunochromatography method or agglutination method.
2. Emergency testing
Even if a quick and simple detection reagent conducted as an emergency response is determined to be negative, it is recommended to retest with a detection reagent with even higher detection sensitivity as necessary.
3. Follow-up test for patients diagnosed with hepatitis B
Detection reagents using any method such as EIA method/chemiluminescence method, agglutination method, immunochromatography method, etc. can be used, but in the case of negative conversion, we recommend checking using a method with higher detection sensitivity.
(Note) Immediately after HBV infection, the amount of virus is extremely low, and no matter how sensitive the detection reagent is used, the virus cannot be detected. This period is called the “window period,” and HBs antigen may not always be detected in blood collected during the window.
[Performance]
[0366 8] Detection limit (minimum detection sensitivity) 4 IU/mL [natural sedimentation method]
[6488 8] Sensitivity 0.005 IU/mL or more.
CONTAINER
S09 旧容器記号 C1 1 セ X1
分離剤入り (真空採血量9mL)
貯蔵方法：室温
有効期間：製造から1年
A00 旧容器記号 X
ポリスピッツ
貯蔵方法：室温
