SARS-CoV-2 IgG/IgM Rapid Test Kits

Prix FOB

Obtenir le dernier prix

3.9 ~ 5.2 USD / Piece ( Negotiable )

2000 Piece Minimum Order

Pays:

China

N Â° de modÃ¨le:

COVID-19

Prix FOB:

3.9 ~ 5.2 USD / Piece ( Negotiable )(Negotiable) Obtenir le dernier prix

LocalitÃ©:

China

Prix de commande minimale:

3.9 per Piece

Commande minimale:

2000 Piece

Packaging Detail:

25pcs/box; 2000pcs/carton

Heure de livraison:

5-7days after payment

Capacité de Fournir:

50000 Piece per Week

Payment Type:

T/T

Groupe de produits :

COVID-19 TEST

Contacter maintenant

SHANGHAI HEALTHSKY MEDICAL PRODUCTS CO., LTD

China

Membre gratuit

Personne Ã contacter Kevin

Longlin, Shanghai, Shanghai

Contacter maintenant

SpÃ©cification du produit

IgG/IgM:Rapid Test

La description

SARS-CoV*2 IgG/IgM Rapid Test Kits
Brand: LUNGENE
Packing:*5sets/box;***0sets/carton;

INTENDED USE
SARS-CoV*2 IgG/IgM Rapid Test Kits is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies(IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Novel coronavirus.
COMPOSTION
Test Cassettes***5pcs;
Buffers***5bottles;
Laplace droppers***5pcs;
Blood sampling needles***5pcs;
Alcohol Pads***5pcs;
Material Required But Not Provided
Specimen collection container Timer

SPECIMEN
The test can be used to test Whole Blood/Serum/Plasma specimens.
To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
Strore specimens at **8°c(****6°F) if not tested immediately. Store specimens at **8°c up to 7 days. The specimens should be frozen at **0°c(*4°F) for longer storage. Do not freeze whole blood specimens.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing.
Do not use samples demonstrating gross lipemia, groos hemolysis or turbidity in order to avoid interference on result interpretation.

TEST PROCEDURE
Allow the test device and specimens to equilibrate to temterature(****0°c or ****6°FG) prior to testing.

Remove the test cassettes from the sealed pouch.
Hold the dropper vertically and transfer 1 drop of specimen(approximately *0Ul) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately *0ul) and start the timer. See the illustration below.
Wait for colored lines to appear. Interpret the test results in *5 minutes. Do

Not read results after *0 minutes.

PERFORMANCE CHARACTERISTICS
Summary data of COVID**9 IgG/IgM Rapid Test as below:
Regarding the IgM test, the result comparison to RT-PCR.
COVID**9 IgM:

COVID**9 IgM		RT-PCR		Total
COVID**9 IgM		Positive	Negative	Total
CLUGENE	Positive	*7	1	*8
CLUGENE	Negative	*0	*9	*9
Total		*7	*0	**7

A statistical comparson was made between the results yielding a sensitivity of *7.*1%, a specificity of *8.*9% and an accuracy of *3.*1%
Regarding the IgG test, we have counted the positive rate of the *7 patients during the convalescence period.
COVID**9 IgG:

COVID**9 IgG		Number of patients during the convalescence period	Total
CLUGENE	Positive	*5	*5
CLUGENE	Negative	2	2
		*7	*7

Cross-Reactivity and Interference

Other common causative agents of infectious diseases were evaluated for cross reactivity with the test. Some positive specimens of other common infectious diseases were spiked into the Novel coronavirus positive and negative specimens and tested separately. No cross reactivity was observed with specimens from patients infected with HIV, HAV, HBsag, HCV, TP, HtLV, CMV, FLUA, FLUB, RSV, MP. CP. HPIVs.
Potentially cross-reactive endogenous substances including common serum components, such as lipids, hemoglobin, bilirubin, were spiked at high concentrations nto the Novel coronavirus positive and negative specimens and tested, separately. No cross reactivity or interference was observed to the device.

Analytes	Conc.	Specimens
Analytes	Conc.	Positive	Negative
Albumin	*0mg/ml	+	-
Bilirubin	*0ug/ml	+	-
Hemoglobin	*5mg/ml	+	-
Glucose	*0mg/ml	+	-
Uric Acid	**0ug/ml	+	-
Lipids	*0mg/ml	+	-

Some other common biological analytes were spiked into the Novel coronavirus positive and negative specimens and tested separately. No significant interference was observed at the levels listed in the table below.

Analytes	Conc (ug/ml)	Specimens
Analytes	Conc (ug/ml)	Positive	Negative
Acetaminophen	**0	+	-
Acetoacetic Acid	**0	+	-
Acetylsalicylic Acid	**0	+	-
Benzoylecgonine	**0	+	-
Caffeine	**0	+	-
EDTA	**0	+	-
Ethanol	1.0%	+	-
Gentisic Acid	**0	+	-
β-Hydroxybutyrate	****0	+	-
Methanol	*0.0%	+	-
Phenothiazine	**0	+	-
Phenylpropanolamine	**0	+	-
Salicylic Acid	**0	+	-

Reproducibility
Reproducibility studies were performed for Novel coronavirus IgG/IgM Rapid Test at three physician office laboratoried(POL). Sixty (*0) clinical serum specimens, *0 negative, *0 borderline positive and **0 positive, were used in theis study, Each specimen was run in triplicate for three days at each POL.
The intra-assay agreements were **0%. The inter-site agreement was **0%.

Pays:	China
N Â° de modÃ¨le:	COVID-19
Prix FOB:	3.9 ~ 5.2 / Piece ( Negotiable ) (Negotiable) Obtenir le dernier prix
LocalitÃ©:	China
Prix de commande minimale:	3.9 per Piece
Commande minimale:	2000 Piece
Packaging Detail:	25pcs/box; 2000pcs/carton
Heure de livraison:	5-7days after payment
Capacité de Fournir:	50000 Piece per Week
Payment Type:	T/T
Groupe de produits :	COVID-19 TEST