| rhTNK-tPA

Recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) represents the most advanced thrombolytic agent currently available internationally, featuring cutting-edge technology and superior therapeutic efficacy. China's independently developed rhTNK-tPA has filled a critical gap in this medical field, and upon successful validation of its safety and clinical effectiveness, this innovative drug is expected to significantly improve treatment outcomes for Chinese patients with acute ST-segment elevation myocardial infarction (STEMI), potentially revolutionizing the current thrombolytic therapy paradigm in domestic cardiovascular emergency care.
 

| Typical data

As the OD values of the standard curve may vary according to the conditions of the actual assay performance (e.g. operator, pipetting technique, wash technique or temperature effects), the operator should establish a standard curve for each test. Typical standard curve and data are provided below for reference only.

 

Concentration (pg/mL)	100	50	25	12.5	6.25	3.12	1.56	0
OD	2.22	1.56	0.92	0.63	0.42	0.25	0.18	0.01
Corrected OD	2.14	1.48	0.84	0.55	0.34	0.17	0.1	-

 

| Repeatability

Intra-assay Precision (Precision within an assay)：CV% < 10%; Inter-assay Precision (Precision between assays)：CV% < 10%
 

| Recovery

The recovery of Human rhTNK-tPA spiked at three different levels in samples throughout the range of the assay was evaluated in various matrices.

 

Sample Type	Range(%)	Average Recovery(%)
Serum(n=8)	84-102	97
Plasma(n=8)	92-106	103
Cell Culture Supernates(n=8)	96-108	105

 

| Linearity

Samples were spiked with high concentrations of Human rhTNK-tPA and diluted with Universal Diluent to produce samples with values within the range of the assay.

 

		Serum(n=4)	Plasma(n=4)	Cell Culture Supernates(n=4)
1 : 2	Range (%)	84-95	88-96	90-110
	Average (%)	91	93	96
1 : 4	Range (%)	89-104	87-108	105-115
	Average (%)	95	98	108