Package size

100 Tests, 50 Tests, 25 Tests, 10 Tests, 5 Tests, 100 Tests (N-QC), 50 Tests (N-QC), 25 Tests (N-QC), 10 Tests (N-QC), 5 Tests (N-QC).

Intended use

This device is intended to be used for the in vitro quantitative determination of Procalcitonin (PCT) and Interleukin-6 (IL-6) in human whole blood, serum or plasma. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

PCT is the prohormone of calcitonin, which consists of 116 amino acid residues and has a molecular weight of about 12.8 kD. It is a glycoprotein without hormone activity and an endogenous non-steroidal anti-inflammatory substance. It is produced by the thyroid in non-infectious situations. In systemic infections, especially bacterial infections, different types of cells in many organs are stimulated by proinflammatory responses to secrete PCT. PCT metabolism depends little on renal function and is not affected by steroid hormones. In clinical diagnosis, the level of PCT in patients with sepsis increased earlier, which is convenient for early diagnosis and monitoring by doctors. In the case of systemic infection, the PCT content in serum begins to increase within 2-4 hours, reaches a peak within 8-24 hours, and lasts for several days or weeks. When it is greater than a certain value, patients have the potential to develop severe sepsis and septic shock. In addition, PCT is an important marker that can specifically distinguish bacterial infection and inflammatory response caused by other reasons. Viral infection, allergy, autoimmune disease and transplant rejection will not cause a significant increase in PCT, while local bacterial infection can result in moderately elevated PCT levels. Therefore, PCT is an ideal indicator for the auxiliary diagnosis of severe bacterial infection, sepsis and other diseases, and has high sensitivity and specificity for systemic bacterial infection, sepsis, etc.

Interleukin-6 is a pleiotropic cytokine with a wide range of functions. It is an intermediary of the immune system. It is expressed in single cells and contains 212 amino acids. It can be cut to form a mature protein of 184 amino acids with a molecular weight of about 22-27 kDa. A large number of studies have found that interleukin-6 not only has physiological activities on B cells, but also has physiological effects on T cells, hematopoietic stem cells, liver cells, and brain cells. Interleukin-6 is rapidly produced during acute inflammatory responses to trauma, surgery, stress, infection, and other conditions. Interleukin-6 levels in surgical patients can predict the occurrence of surgical complications. Serial detection of serum or plasma interleukin-6 levels in intensive care (ICU) patients can effectively assess the severity of systemic inflammatory response syndrome (SIRS), sepsis, and the prognosis of septic shock. Interleukin-6 also acts as an early warning indicator of sepsis.

For inflammatory and infectious diseases, PCT has high specificity and IL-6 has high sensitivity. Combined detection of PCT and IL-6 can not only improve the early diagnosis rate of infection, avoid missed diagnosis, but also reduce misdiagnosis.

The current clinical methods for detecting PCT & IL-6 include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® PCT & IL-6
Format	Cassette	Reaction Time	10min
Linearity	PCT: 0.02～ 50ng/L IL-6: 2～2000pg/L	Reference Interval	PCT: ＜0.05ng/mL IL-6: ＜7 pg/mL
Sample	S / P	Certificate	CE / NMPA*

ORDERING
Cat. No.	LMFMPI25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LAFMPI25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T