金准生物，量子点，炎症二联检

[Product Name]PCT/IL-6 Detection Kit

[Sample Type]Serum, plasma, whole blood, or capillary blood

[Intended Use]
For the in vitro quantitative detection of Procalcitonin/Interleukin-6 (PCT/IL-6) in human serum, plasma, whole blood, or capillary blood.

[Clinical Department]
Clinical Laboratory, Emergency Department/ICU, Infectious Diseases Department, Respiratory Department, Paediatrics Department, Neonatology Department, Haematology Department, Rheumatology Department, etc.

Product Parameters
Item	PCT/IL-6
Test Time	18min
Sample Type	serum, plasma, whole blood, or capillary blood
Sensitivity	0.01ng/ml、 0.002ng/ml
Storage Condition	4-30℃
Packing Specification	Card Type: 25 Tests/Kit, 50 Tests/Kit Cartridge type: 25 Tests/Kit, 50 Tests/Kit

1. It enables rapid detection of positive results in the early stage of infection, facilitating prompt screening of infection sources, and assisting in determining the infection progression and recovery status.

2. It can assist in differentiating COVID-19 from other common respiratory diseases, helping primary medical institutions to triage patients, reduce the risk of cross-infection, and improve the efficiency of diagnosis and treatment.

3. When combined with clinical manifestations and epidemiological data, it can provide early risk alerts for high-risk groups such as the elderly and patients with underlying conditions, thus offering references for severe case assessment and intervention.

4. It can be used for dynamic monitoring post-infection; sequential test results can reflect the condition recovery progress, providing evidence for prognosis evaluation and isolation management.

PCT/IL-6 Clinical Application
PCT (ng/mL)	IL-6 (ng/mL)	Clinical Application Recommendations
>0.5	>0.250	Indicates a high probability of sepsis.
>0.5	<0.250	Suggests potential bacterial infection or systemic inflammatory response syndrome.
<0.5	<0.250	Normal results may indicate the presence of mild inflammation or mild infection.
For assessing infection severity and prognostic evaluation: IL-6 levels exceeding 1000 ng/mL are indicative of poor prognosis.
*Each laboratory shall verify the applicability of the established reference ranges through internal validation studies; it is advisable to establish laboratory-specific reference ranges where necessary.

Number	Controls	Number of registration certificate
1	降钙素原质控品（Procalcitonin（PCT）Control）	粤械注准 20172400844
2	白介素6质控品（Interleukin-6（IL-6）Control）	粤械注准 20172400852
3	C反应蛋白质控品（C-Reactive Rrotein（CRP）Control）	粤械注准 20172400847
4	心肌肌钙蛋白 I 质控品（Cardiac Troponin I（cTnl）Control）	粤械注准 20172400846
5	肌酸激酶同工酶质控品（Creatine kinase Isoenzyme-MB（CK-MB）Control）	粤械注准 20172400849
6	D · 二聚体制控品（D-Dimer Control）	粤械注准 20172400843
7	人心型脂肪酸结合蛋白质控品（Human Heart-type Fatty Aeid Binding Rrotein（H-FABP）Control）	粤械注准 20172400851
8	肌红蛋白质控品（Myoglobin（MYO）Control）	粤械注准 20172400848
9	N末端脑钠肱前体质控品（N-terminal pro-B-type natriuretic peptide（NT-proBNP）Control）	粤械注准 20172400845
10	中性粒细胞明胶酶相关脂质运载蛋白质控品（Neutrophil gelatinase-assoiated lipocalin（NGAL）Control）	粤械注准 20172400850